Metastatic Hormone-sensitive Prostate Cancer Articles

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  • A Multi-arm, Multi-stage, Randomized Phase II/III Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

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    A Multi-arm, Multi-stage, Randomized Phase II/III Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer


    Condition: Metastatic Hormone-sensitive Prostate Cancer

    Intervention:

    • Drug: Ipilimumab 5 MG/ML
    • Drug: Nivolumab 10 MG/ML
    • Drug: Docetaxel
    • Drug: ADT (androgen deprivation therapy)

    Purpose: Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT). However, the disease progresses in virtually all patients to the state of castration resistant prostate cancer (CRPC), with a median time to progression of 24 months. Patients with high volume disease (with either visceral metastasis and/or bone metastasis) exhibit a worse prognosis, with a median clinical progression of 14 months. Recently, the CHAARTED and STAMPEDE studies demonstrated that the combination of Docetaxel (chemotherapy) and ADT delayed the clinical progression and improved the survival a median of 14 months (17 for high volume patients). Nevertheless, the prognosis of patients with high volume metastatic disease continues to be poor. Meanwhile the immunotherapy, the use of antibodies that recognize tumoral cells and promote the immune system activity against the cancer, has emerged as a very useful option in many cancers. Among others, the antibodies Nivolumab and Ipilimumab have been approved for the treatment of multiple types of cancer. In this context, SOGUG (Spanish Oncology Genitourinary Group) has designed this new study "PROSTRATEGY" with the objective of evaluating whether the addition of immunotherapy to chemotherapy and ADT improves the prognosis and survival of patients with high volume metastatic hormone-sensitive prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03879122

    Sponsor: Spanish Oncology Genito-Urinary Group

    Primary Outcome Measures:

    • Measure: Overall Survival
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: PSA response
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: PSA progression-free survival (PSA-PFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Radiological progression-free survival (rPFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Clinical progression-free survival (cPFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Time to castration resistant prostate cancer (TCRPC)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Immune radiological progression-free survival (irPFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Immune clinical progression-free survival (icPFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Time to immune castration resistant prostate cancer (TiCRPC)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Symptomatic skeletal-related event free survival (SSREFS)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Toxicity of each of the treatment arms by assessing Adverse Events
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Quality of life (QOL)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Quality of life (QOL)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:
    • Measure: Quality of life (QOL)
    • Time Frame: through study completion, an average of 2 years
    • Safety Issue:

    Estimated Enrollment: 135

    Study Start Date: February 11, 2019

    Phase: Phase 2/Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Patients must be at least 18 years of age 2. Signed and dated written informed consent, obtained before the performance of any protocol-related procedure. 3. Histological or cytological diagnosis of prostate cancer with an elevated PSA level and radiologic evidence of metastatic disease. 4. ECOG performance-status score of 0, 1, or 2. Patients with a score of 2 are eligible if the decrement in functioning was due to prostate cancer. 5. Metastatic disease that has spread beyond the prostate or relapsed after local therapy, documented by body CT scan and/or bone scan, according to PCWG 3 criteria, with high volume according to criteria used in the CHAARTED study. 6. Radiological and scintigraphic studies to identify initial evaluable disease should be done as follows:
    • If ADT has not been initiated, CT scans and bone scan must be obtained within 6 weeks prior to the start of ADT.
    • If all required imaging had not been completed prior to starting ADT, any additional scan must be obtained after starting androgen deprivation but prior to randomization and the initiation of docetaxel (It is assumed that the scans of patients with high volume disease would not normalize in less than 120 days to the point that a patient would go from "high volume" to "low volume"). 7. Measurable or evaluable disease according to the PWGC 3. 8. Patients who started ADT for metastatic disease are eligible if ADT commenced within 120 days before randomization, they have not started docetaxel chemotherapy yet, and there was no evidence of clinical, radiological or biochemical progression after ADT. 9. Patients receiving ADT in the adjuvant and/or neoadjuvant setting for less than 30 months of therapy, AND the effect of the last depot injection had expired at least 12 months prior to documentation of metastatic disease, AND
    • They had no evidence of disease (PSA < 0.2 ng/dL) after prostatectomy plus hormonal therapy, or
    • PSA was < 0.5 ng/dL after completing radiation therapy plus adjuvant or neoadjuvant hormonal therapy, and had not doubled above nadir in at least 12 months. 10. Patients must have adequate organ function within 4 weeks prior to randomization and evidenced by:
    • Absolute Neutrophil Count > 1500/mm 3
    • Platelet count > 100,000/mm 3
    • Creatinine clearance (CrCl)> 30 mL/min calculated at screening using the Cockcroft- Gault formula: Creatinine clearance for mule (mL/min) = (140- age in years)(body weight in kg)/[72x(serum creatinine in mg/dl).
    • Total bilirubin < 1.5 ULN (< 3.0 mg/dl in patients with Gilbert´s Syndrome).
    • Prothrombin time or INR and PTT < 1.5 x ULN, except if on therapeutic anti- coagulation in which case the patient can be enrolled if stable and anti-coagulation levels are appropriate for their condition per good clinical practice.
    • ALT and AST < or = 3 x ULN (or < or = 5 if liver metastases) 11. At least 4 weeks should have passed after major surgery prior to randomization, and the patient should be recovered from all side effects and complications. 12. Men who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days (duration of sperm turnover) for a total of 31 weeks post-treatment completion.

    Exclusion Criteria:

    1. Patients are not eligible if the PSA has risen from its lowest point, between the beginning of androgen deprivation therapy and the date of randomization, and met criteria for progression as defined in the protocol.
    2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, PROSTVAC, Sipuleucel-T or any previous immunotherapy or vaccines for cancer.
    3. Prior chemotherapy in the adjuvant or neoadjuvant setting.
    4. Unable to receive docetaxel at full doses at investigator criteria.
    5. Peripheral neuropathy grade >
    6. All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia or fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to prior surgery or radiotherapy, which are not expected to resolve and result in long-term lasting sequelae, are permitted to enrol.
    7. History of hypersensitivity reaction to Docetaxel®, other drugs formulated with polysorbate 80, or monoclonal antibodies.
    8. Prior hormone therapy or immunotherapy in the metastatic setting.
    9. Prior palliative radiation therapy within 30 days of starting docetaxel.
    10. Known acute or chronic HIV, Hepatitis B, or Hepatitis C. Past Hepatitis B infection with no signs of activity later, are allowed
    11. Active brain metastases or leptomeningeal metastases, except if they have been treated and there is a magnetic resonance imaging (or CT scan if MRI were contraindicated) showing no evidence of progression for at least 4 weeks after the treatment
    12. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days previous to randomization. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
    13. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed.
    14. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous six months
    15. History of malignancy in the past 5 years except for basal cell and squamous cell carcinoma of the skin and non-muscle-invasive bladder cancer. Other more malignancies considered to have a low potential to progress may be enrolled if approved by study chair.
    16. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
    17. Participation in another clinical trial within 30 days prior to randomization.

    Contact:

    • Jose Ángel Arranz Arija, MD, PhD
    • +34 610287201

    Locations:

    • Hospital Universitario Central de Asturias
    • Oviedo Asturias 33011 Spain
    • Hestia Duran I Reynals
    • Hospitalet de Llobregat Barcelona 08908 Spain
    • Hospital Sant Joan de Deu (Althaia Manresa)
    • Manresa Barcelona 08242 Spain
    • Hospital de Sabadell
    • Sabadell Barcelona 08208 Spain
    • Hospital General, Materno E Infantil Reina
    • Córdoba Cordoba 14004 Spain
    • Hospital Son Llatzer
    • Palma De Mallorca Islas Baleares 07198 Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
    • Majadahonda Madrid 28222 Spain
    • Hospital Universitario Infanta Sofía
    • San Sebastián De Los Reyes Madrid 28072 Spain
    • Complejo Hospitalario de Navarra
    • Pamplona Navarra 31008 Spain
    • Hospital Arnau de Vilanova
    • Valencia Valenci 46015 Spain
    • Hospital de Basurto
    • Bilbao Vizcaya 48013 Spain
    • Hospital Del Mar
    • Barcelona 08003 Spain
    • Hospital Universitari Vall D'Hebron
    • Barcelona 08035 Spain
    • Hospital Clínic de Barcelona
    • Barcelona 08036 Spain
    • Hospital Universitario de Burgos
    • Burgos 09006 Spain
    • Hospital General de Ciudad Real
    • Ciudad Real 13005 Spain
    • Hospital San Pedro de Alcántara
    • Cáceres 10003 Spain
    • Hospital Universitari de Girona Dr. Josep Trueta
    • Girona 17007 Spain
    • Hospital Universitario Lucus Augusti
    • Lugo 27003 Spain
    • Hospital General Universitario Gregorio Marañón
    • Madrid 28007 Spain
    • Hospital Ramón Y Cajal
    • Madrid 28013 Spain
    • Hospital Clínico San Carlos
    • Madrid 28040 Spain
    • Hospital Universitario 12 de Octubre
    • Madrid 28041 Spain
    • Hospital Virgen Del Rocío
    • Sevilla 41013 Spain
    • Hospital Nuestra Señora de Valme
    • Sevilla 41014 Spain
    • Hospital Virgen Macarena
    • Sevilla 41071 Spain
    • Hospital Virgen de La Salud
    • Toledo 45004 Spain
    • Fundación Instituto Valenciano de Oncología
    • Valencia 46009 Spain
    • Consorcio Hospital General Universitario de Valencia
    • Valencia 46014 Spain
    • Hospital Universitario Alvaro Cunqueiro
    • Vigo 36312 Spain

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

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    A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)


    Condition: Metastatic Hormone Sensitive Prostate Cancer

    Intervention:

    • Drug: Enzalutamide
    • Drug: Placebo

    Purpose: The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02677896

    Sponsor: Astellas Pharma Global Development, Inc.

    Primary Outcome Measures:

    • Measure: Radiographic progression-free survival (rPFS)
    • Time Frame: Up to 4 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall survival (OS)
    • Time Frame: Up to 7 years
    • Safety Issue:
    • Measure: Time to first symptomatic skeletal event (SSE)
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Time to castration resistance
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Time to deterioration of quality of life (QoL)
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Time to initiation of a new antineoplastic therapy
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Time to PSA progression
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: PSA undetectable rate
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Objective response rate
    • Time Frame: Up to 4 years
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: Up to 4 years
    • Safety Issue:

    Estimated Enrollment: 1100

    Study Start Date: March 7, 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Subject is considered an adult according to local regulation at the time of signing informed consent.
    • Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
    • Subject has metastatic prostate cancer documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan. Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.
    • Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    Exclusion Criteria:

    • Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
    • Up to 3 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
    • Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
    • Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
    • Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
    • Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
    • Subject had a major surgery within 4 weeks prior to day 1.
    • Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.
    • Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
    • Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1.
    • Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
    • Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
    • Subject has known or suspected brain metastasis or active leptomeningeal disease.
    • Subject has absolute neutrophil count < 1500/μL, platelet count < 100000/μL or hemoglobin < 10 g/dL (6.2 mmol/L).
    • Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN .
    • Subject has creatinine > 2 mg/dL (177 μmol/L).
    • Subject has albumin < 3.0 g/dL (30 g/L).
    • Subject has a history of seizure or any condition that may predispose to seizure.
    • Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1.
    • Subject has clinically significant cardiovascular disease.
    • Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis

    Contact:

    • Astellas Pharma Global Development
    • 800-888-7704 Ext. 5473

    Locations:

    • Site US10016
    • Homewood Alabama 35209 United States
    • Site US10007
    • Anchorage Alaska 99503 United States
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    • Site US10034
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    • Site US10026
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    • Site US10036
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    • Site US10018
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    • Site FR33010
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    • Site DE49014
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    • Site DE49001
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    • Site DE49013
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    • Site DE49006
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    • Site IL97201
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    • Seoul Korea, Republic of
    • Site NL31002
    • Sneek Friesland Netherlands
    • Site NL31003
    • Nijmegen Gelderland Netherlands
    • Site NL31007
    • Nijmegen Gelderland Netherlands
    • Site NL31005
    • Eindhoven Noord-Brabant Netherlands
    • Site NL31010
    • Alkmaar Noord-Holland Netherlands
    • Site NL31004
    • Amsterdam Noord-Holland 1105 AZ Netherlands
    • Site NL31008
    • Amsterdam Noord-Holland Netherlands
    • Site NL31009
    • Zwolle Overijssel Netherlands
    • Site NL31006
    • Rotterdam Zuid-Holland Netherlands
    • Site NZ64003
    • Tauranga Bay Of Plenty New Zealand
    • Site NZ64008
    • Kensington Northland New Zealand
    • Site NZ64002
    • Dunedin South Island New Zealand
    • Site NZ64005
    • Nelson Tasman District New Zealand
    • Site NZ64006
    • Christchurch New Zealand
    • Site NZ64004
    • Hamilton New Zealand
    • Site PL48003
    • Wroclaw Dolnoslaskie Poland
    • Site PL48007
    • Krakow Malopolskie Poland
    • Site PL48008
    • Warszawa Mazowieckie Poland
    • Site PL48011
    • Warszawa Mazowieckie Poland
    • Site PL48005
    • Gdańsk Pomerania Poland
    • Site PL48010
    • Slupsk Pomorskie Poland
    • Site PL48001
    • Myslowice Poland
    • Site RO40008
    • Cluj-Napoca Cluj Romania
    • Site RO40009
    • Cluj-Napoca Cluj Romania
    • Site RO40002
    • Floresti Cluj Romania
    • Site RO40011
    • Timisoara Timis Romania
    • Site RO40007
    • Brasov Romania
    • Site RO40003
    • Bucharest Romania
    • Site RO40006
    • Bucharest Romania
    • Site RO40004
    • Sibiu Romania
    • Site RU70013
    • Ivanovo Russian Federation
    • Site RU70001
    • Moscow Russian Federation
    • Site RU70003
    • Moscow Russian Federation
    • Site RU70014
    • Moscow Russian Federation
    • Site RU70006
    • Omsk Russian Federation
    • Site RU70005
    • Penza Russian Federation
    • Site RU70007
    • St. Petersburg Russian Federation
    • Site RU70008
    • St. Petersburg Russian Federation
    • Site RU70009
    • St. Petersburg Russian Federation
    • Site RU70012
    • St. Petersburg Russian Federation
    • Site RU70016
    • St. Petersburg Russian Federation
    • Site SK42110
    • Bratislava Slovakia
    • Site SK42109
    • Kosice Slovakia
    • Site SK42102
    • Michalovce Slovakia
    • Site SK42103
    • Nitra Slovakia
    • Site SK42101
    • Poprad Slovakia
    • Site SK42107
    • Trencin Slovakia
    • Site SK42106
    • Žilina 012 07 Slovakia
    • Site ES34018
    • Santiago de Compostela A Coruna Spain
    • Site ES34011
    • Salamanca A Coruña Spain
    • Site ES34020
    • Oviedo Asturias Spain
    • Site ES34010
    • Sabadell Barcelona Spain
    • Site ES34012
    • Barcelona Cataluña Spain
    • Site ES34014
    • Barcelona Cataluña Spain
    • Site ES34013
    • Valencia Comunidad Valenciana Spain
    • Site ES34006
    • Pamplona Navarra Spain
    • Site ES34001
    • Avila Spain
    • Site ES34007
    • Barcelona Spain
    • Site ES34004
    • Madrid Spain
    • Site ES34019
    • Madrid Spain
    • Site SE46002
    • Örebro Orebro Län Sweden
    • Site SE46001
    • Malmö Skåne Län Sweden
    • Site SE46006
    • Stockholm Sodermanlands Lan Sweden
    • Site SE46004
    • Sundsvall Vasternorrlands Lan Sweden
    • Site SE46007
    • Goteborg Vastra Gotalands Lan Sweden
    • Site TW88601
    • Kaohsiung 112 Taiwan
    • Site TW88606
    • Taichung 40705 Taiwan
    • Site TW88602
    • Taipei Taiwan
    • Site TW88605
    • Taipei Taiwan
    • Site TW88607
    • Taoyuan 333 Taiwan
    • Site GB44002
    • Withington Manchester United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • A Phase 2 Trial of Radium Ra 223 Dichloride in Combination With Androgen Deprivation Therapy and Stereotactic Body Radiation Therapy for Patients With Oligometastatic Castration Sensitive Prostate Cancer

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    A Phase 2 Trial of Radium Ra 223 Dichloride in Combination With Androgen Deprivation Therapy and Stereotactic Body Radiation Therapy for Patients With Oligometastatic Castration Sensitive Prostate Cancer


    Condition: Prostate Adenocarcinoma

    Intervention:

    • Drug: Leuprolide Acetate
    • Drug: Goserelin Acetate
    • Radiation: Stereotactic Body Radiation Therapy
    • Radiation: Radium Ra 223 Dichloride
    • Other: Laboratory Biomarker Analysis
    • Drug: Degarelix

    Purpose: This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body radiation may work better at treating prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03361735

    Sponsor: City of Hope Medical Center

    Primary Outcome Measures:

    • Measure: Time to treatment failure
    • Time Frame: Assessed up to 5 years
    • Safety Issue:
    • Measure: Objective response rate
    • Time Frame: Up to 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Progression-free survival
    • Time Frame: From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years
    • Safety Issue:
    • Measure: Overall survival
    • Time Frame: From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years
    • Safety Issue:
    • Measure: Complete response (CR) rate defined as the proportion of patients achieving CR
    • Time Frame: Up to 5 years
    • Safety Issue:
    • Measure: Duration of response
    • Time Frame: From documented response to recurrent or progressive disease is first met, assessed up to 5 years
    • Safety Issue:
    • Measure: Duration of overall complete response
    • Time Frame: From documented CR to recurrent/ progressive disease, assessed up to 5 years
    • Safety Issue:
    • Measure: Bone specific progression-free survival
    • Time Frame: Time to progression of bone specific disease over baseline, assessed up to 5 years
    • Safety Issue:
    • Measure: Duration of stable disease
    • Time Frame: Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years
    • Safety Issue:
    • Measure: Incidence of adverse events (AE) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
    • Time Frame: Up to 5 years
    • Safety Issue:

    Estimated Enrollment: 24

    Study Start Date: August 29, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Documented informed consent of participant and/or legally authorized representative
    • Agreement to provide archival primary or metastatic tumor tissue if available
    • Eastern Cooperative Oncology Group (ECOG) =< 2
    • Life expectancy > 12 months
    • Histologic diagnosis of prostate adenocarcinoma * Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen
    • Stage M1 * Metastatic disease can be documented by bone scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT or the combination of these tests
    • Up to 4 metastatic lesions:
    • Must have at least 1 bone lesion AND each non-visceral lesion should be less than 5 cm
    • Visceral lesions will be limited to one lung lesion (< 2 cm) or one lymph node; no liver lesions allowed; lymph nodes allowed provided they are not in a field of prior radiation, and if amenable to SBRT (to be reviewed by principal investigator [PI])
    • Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements
    • If have untreated primary prostate cancer: must undergo debulking prostatectomy
    • If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI); retreatment to local residual-recurrent disease will result in potential eligibility to be reviewed by PI on a case-by-case basis
    • Does not have castration resistant disease * Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL
    • PSA >= 0.2 prior to start of androgen deprivation treatment
    • Initiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy * Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count
    • May have received prior hormonal therapy in the context of definitive treatment of a primary tumor * Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease
    • Must have refused standard of care chemotherapy for metastatic disease
    • Recovered from all acute side-effects (except alopecia) related to previous systemic therapy
    • Absolute neutrophil count (ANC) >= 1,500/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care
    • Platelets >= 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
    • Hemoglobin (HgB) >= 9.0 g/dL (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
    • Total serum bilirubin =< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy)
    • Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
    • Alanine aminotransferase (ALT) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
    • Creatinine =< 2.5 mg/dL (to be performed within 14 days prior to day 1 of protocol therapy)

    Exclusion Criteria:

    • Prior radium Ra 223 dichloride
    • Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:
    • Prior chemotherapy for local primary disease is permitted
    • Bisphosphonates or receptor activator of nuclear factor kappa-Β (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis
    • Prior radiation treatment for metastatic disease
    • Concomitant radiation treatment to primary prostate site
    • Orchiectomy
    • Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities)
    • Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
    • History of brain metastases or who currently have treated or untreated brain metastases
    • Uncontrolled human immunodeficiency virus (HIV) infection
    • Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
    • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

    Contact:

    • Savita Dandapani, MD
    • 626 256-4673

    Location:

    • City of Hope Medical Center
    • Duarte California 91010 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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    A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)


    Condition: Prostate Cancer

    Intervention:

    • Drug: Apalutamide
    • Drug: Placebo
    • Drug: Androgen Deprivation Therapy (ADT)

    Purpose: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02489318

    Sponsor: Aragon Pharmaceuticals, Inc.

    Primary Outcome Measures:

    • Measure: Radiographic Progression-Free Survival (rPFS)
    • Time Frame: Up to 54 Months
    • Safety Issue:
    • Measure: Overall Survival (OS)
    • Time Frame: Up to 54 Months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Time to Pain Progression
    • Time Frame: Up to 54 Months
    • Safety Issue:
    • Measure: Time to Skeletal-Related Event (SRE)
    • Time Frame: Up to 54 Months
    • Safety Issue:
    • Measure: Time to Chronic Opioid Use
    • Time Frame: Up to 54 Months
    • Safety Issue:
    • Measure: Time to Initiation of Cytotoxic Chemotherapy
    • Time Frame: Up to 54 Months
    • Safety Issue:

    Estimated Enrollment: 1000

    Study Start Date: November 27, 2015

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Diagnosis of prostate adenocarcinoma as confirmed by the investigator
    • Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
    • Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
    • Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
    • Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies

    Exclusion Criteria:

    • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
    • Known brain metastases
    • Lymph nodes as only sites of metastases
    • Visceral (ie, liver or lung) metastases as only sites of metastases
    • Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
    • Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
    • History of seizures or medications known to lower seizure threshold

    Contact:

    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

    Locations:

    • Urology Centers Of Alabama
    • Homewood Alabama 35209 United States
    • 21st Century Oncology
    • Scottsdale Arizona 85251 United States
    • Arizona Institute of Urology
    • Tucson Arizona 85704 United States
    • Urological Associates of Southern Arizona, P.C.
    • Tucson Arizona 85741 United States
    • Cedars-Sinai Medical Center
    • Los Angeles California 90048 United States
    • Greater Los Angeles VA Healthcare System
    • Los Angeles California 90073 United States
    • San Bernardino Urological Associates
    • San Bernardino California 92404 United States
    • Genesis Research
    • San Diego California 92123 United States
    • The Urology Center of Colorado
    • Denver Colorado 80211 United States
    • Norwalk Hospital
    • Norwalk Connecticut 06477 United States
    • 21st Century Oncology
    • Fort Myers Florida 33908 United States
    • Jesse Brown VAMC Department of Surgery
    • Chicago Illinois 60612 United States
    • Rush University
    • Chicago Illinois 60612 United States
    • Fort Wayne Medical Oncology and Hematology, Inc.
    • Fort Wayne Indiana 46804 United States
    • First Urology
    • Jeffersonville Indiana 47130 United States
    • Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic (TCCCC)
    • New Orleans Louisiana 70112-2618 United States
    • Ochsner Clinic Foundation
    • New Orleans Louisiana 70121 United States
    • University of Maryland
    • Baltimore Maryland 21201-1544 United States
    • MidAtlantic Urology Associates
    • Greenbelt Maryland 20770 United States
    • Maryland Oncology Hematology, PA
    • Rockville Maryland 20850 United States
    • Chesapeake Urology Research Associates
    • Towson Maryland 21204 United States
    • Sparrow Regional Cancer center
    • Lansing Michigan 48912 United States
    • Michigan Institute of Urology
    • Troy Michigan 48084 United States
    • Metro Urology
    • Woodbury Minnesota 55125 United States
    • Nebraska Cancer Specialists
    • Omaha Nebraska 68130 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89169 United States
    • Maimonides Cancer Center
    • Brooklyn New York 11220 United States
    • Premier Medical Group
    • Poughkeepsie New York 12601 United States
    • Associated Medical Professionals
    • Syracuse New York 13210 United States
    • Montefiore Medical Center
    • The Bronx New York 10461 United States
    • Associated Urologists of North Carolina
    • Raleigh North Carolina 27612 United States
    • W. G. 'Bill' Hefner VA Medical Center
    • Salisbury North Carolina 28144 United States
    • Piedmont Medical Research
    • Winston-Salem North Carolina 27103 United States
    • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
    • Winston-Salem North Carolina 27157 United States
    • TriState Urologic Services PSC Inc. DBA The Urology Group
    • Cincinnati Ohio 45212 United States
    • University Hospitals Case Medical Center
    • Cleveland Ohio 44106 United States
    • Clinical Research Solutions, LLC
    • Middleburg Heights Ohio 44130 United States
    • Oregon Urology Institute
    • Springfield Oregon 97477 United States
    • Urologic Consultants of SE PA
    • Bala-Cynwyd Pennsylvania 19004 United States
    • Urology Health Specialists, LLC
    • Bryn Mawr Pennsylvania 19010 United States
    • Lancaster Urology
    • Lancaster Pennsylvania 17604 United States
    • Ralph H. Johnson VAMC and Medical University of South Carolina
    • Charleston South Carolina 29401 United States
    • Carolina Urologic Research Center
    • Myrtle Beach South Carolina 29572 United States
    • Urology Associates
    • Nashville Tennessee 37209 United States
    • Urology Clinics of North Texas
    • Dallas Texas 75231 United States
    • Texas Oncology P.A.
    • Houston Texas 77024 United States
    • Houston Metro Urology
    • Houston Texas 77027 United States
    • Urology San Antonio Research
    • San Antonio Texas 78229 United States
    • University of Utah
    • Salt Lake City Utah 84112 United States
    • Virginia Urology Center
    • Richmond Virginia 23235 United States
    • Urology of Virginia, PLCC
    • Virginia Beach Virginia 23642 United States
    • Seattle Urology Research Center
    • Burien Washington 98166 United States
    • Medical Oncology Associates, PS
    • Spokane Washington 99208 United States
    • Madigan Army Medical Center
    • Tacoma Washington 98431 United States
    • University of Wisconsin Carbone Cancer Center
    • Madison Wisconsin 53792 United States
    • Medical College Of Wisconsin
    • Milwaukee Wisconsin 53226-3522 United States
    • COIBA
    • Berazategui B1880BBF Argentina
    • Fundación Investigar
    • C.a.b.a. C1025ABI Argentina
    • Sanatorio Guemes
    • C.a.b.a. C1180AAX Argentina
    • Hospital Italiano de Buenos Aires
    • C.a.b.a. C1181ACF Argentina
    • Instituto Medico Alexander Fleming
    • C.a.b.a. C1426ANZ Argentina
    • Hospital Militar Cosme Argerich
    • C.a.b.a. C1426BOR Argentina
    • Centro de Urologia (CDU)
    • Ciudad Automoma Buenos Aires C1120AAT Argentina
    • CEMIC Saavedra
    • Ciudad Autonoma Buenos Aires C1431FWN Argentina
    • Fundacion Favaloro
    • Ciudad Autonoma De Buenos Aires 1093 Argentina
    • Clínica Adventista Belgrano
    • Ciudad De Buenos Aires C1430EGF Argentina
    • Clinica Sucre
    • Cordoba 5000 Argentina
    • Instituto Oncologico de Cordoba (IONC)
    • Cordoba X5000HXL Argentina
    • Clinica Universitaria Reina Fabiola
    • Cordoba X5004FHP Argentina
    • H.I.G.A. San Roque de Gonnet
    • La Plata 1900 Argentina
    • Centro Oncológico Riojano Integral
    • La Rioja F5300COE Argentina
    • Centro de Investigacion Pergamino SA
    • Pergamino B2700CPM Argentina
    • Sanatorio Britanico de Rosario
    • Rosario 2000 Argentina
    • Instituto de Oncologia de Rosario (IOR)
    • Rosario S2000KZE Argentina
    • Centro Médico San Roque
    • San Miguel De Tucuman T4000IAK Argentina
    • ARS Médica
    • San Salvador De Jujuy Y4600AFW Argentina
    • Clínica Viedma
    • Viedma R8500ACE Argentina
    • Border Medical Oncology Research Unit
    • Albury 2640 Australia
    • The Lyell McEwin Hospital
    • Elizabeth Vale 5112 Australia
    • St George Private Hospital
    • Kogarah 2217 Australia
    • North Coast Cancer Institute
    • Port Macquarie 2444 Australia
    • Mater Hospital Brisbane
    • South Brisbane 4101 Australia
    • Northern Cancer Institute
    • St Leonards 2065 Australia
    • St John of God Subiaco Hospital
    • Subiaco 6008 Australia
    • Fundacao Pio Xii - Hospital De Cancer De Barretos
    • Barretos 14784-400 Brazil
    • UNICAMP
    • Campinas 13083-970 Brazil
    • Centro de Pesquisas Oncológicas - CEPON
    • Florianópolis 88034-000 Brazil
    • Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
    • Goiânia 74605-070 Brazil
    • Hospital de Caridade de Ijui - CACON
    • Ijui 98700-000 Brazil
    • Liga Norte Riograndense Contra O Cancer
    • Natal 59075-740 Brazil
    • Irmandade Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre 90020-090 Brazil
    • Hospital de Clínicas de Porto Alegre
    • Porto Alegre 90035-904 Brazil
    • IRPCC - Instituto Ribeiraopretano de Combate ao Cancer
    • Ribeirao Preto 14015-130 Brazil
    • Instituto Nacional do Cancer - INCA
    • Rio De Janeiro 20231-050 Brazil
    • Hospital Universitário Pedro Ernesto
    • Rio De Janeiro 20551-030 Brazil
    • Instituto COI de Pesquisa, Educação e Gestão
    • Rio De Janeiro 22793-080 Brazil
    • Hospital Santa Isabel
    • Salvador 40050-410 Brazil
    • Núcleo de Oncologia da Bahia
    • Salvador 42700-000 Brazil
    • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
    • Santo André 09060-650 Brazil
    • Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
    • Sao Jose Do Rio Preto 15090-000 Brazil
    • Centro de Pesquisa do Instituto do Cancer Arnaldo Vieira de Carvalho
    • Sao Paulo 01209-000 Brazil
    • IBCC Instituto Brasileiro de Controle do Cancer
    • Sao Paulo 03102-002 Brazil
    • Hospital Santa Marcelina
    • Sao Paulo 08270-070 Brazil
    • Centro de Estudos e Pesquisas Oncologicas de Sorocaba (Instituto de Oncologia de Sorocaba)
    • Sorocaba 18030-075 Brazil
    • Sociedade Hospital Samaritano
    • São Paulo 01232-010 Brazil
    • ICESP - Instituto do Câncer do Estado de São Paulo
    • São Paulo 01246-000 Brazil
    • Hospital Sirio Libanes
    • São Paulo 01308-050 Brazil
    • Fundação Antônio Prudente - A.C. Camargo Cancer Center
    • São Paulo 01509-900 Brazil
    • Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO
    • São Paulo 04039-004 Brazil
    • Hospital Israelita Albert Einstein
    • São Paulo 05651-900 Brazil
    • Southern Alberta Institute of Urology / Prostate Cancer Centre
    • Calgary Alberta T2V 1P9 Canada
    • Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
    • Vancouver British Columbia V5Z 1M9 Canada
    • McMaster Institute of Urology
    • Hamilton Ontario L8N 4A6 Canada
    • Centre for Applied Urological Research
    • Kingston Ontario K7L 3J7 Canada
    • Princess Margaret Cancer Centre
    • Toronto Ontario M5G 2M9 Canada
    • Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc
    • Quebec G1R 2J6 Canada
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)
    • Beijing 100022 China
    • Peking Union Medical College Hospital
    • Beijing 100032 China
    • Peking University First Hospital
    • Beijing 100034 China
    • Beijing Friendship Hospital
    • Beijing 100050 China
    • Beijing Cancer Hospital of Peking University
    • Beijing 100142 China
    • Peking University Shougang Hospital
    • Beijing 100144 China
    • Peking University Third Hospital
    • Beijing 100191 China
    • Beijing Hospital
    • Beijing 100730 China
    • Hunan Cancer hospital
    • Changsha 410013 China
    • The people's Hospital of Sichuan Province
    • Chengdu 610072 China
    • Chongqing Cancer hospital
    • Chongqing 400030 China
    • Southwest Hospital
    • Chongqing 400038 China
    • Fujian Medical University Union Hospital
    • Fuzhou 350001 China
    • Sun Yat-Sen University Cancer Center
    • Guangzhou 430030 China
    • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
    • Guangzhou 510120 China
    • Guangzhou First Municipal People's Hospital
    • Guangzhou 510180 China
    • The Second Affiliated Hospital of Zhejiang University
    • Hangzhou 310009 China
    • Anhui Province Hospital
    • Hefei China
    • The First Affiliated hospital of Anliui Medical University
    • Hefei China
    • Jiangsu Cancer Hospital
    • Nanjing 210000 China
    • Nanjing Drum Tower Hospital
    • Nanjing 210008 China
    • Jiangsu Province Hospital
    • Nanjing 210029 China
    • Fudan Cancer Hospital
    • Shanghai 200032 China
    • Shanghai Zhongshan Hospital
    • Shanghai 200032 China
    • ShangHai Huadong Hospital
    • Shanghai 200040 China
    • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai 200093 China
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
    • Shanghai 200127 China
    • ShangHai Changhai Hospital
    • Shanghai 200433 China
    • Shanghai General Hospital
    • Shanghai 201620 China
    • Second Affiliated Hospital, SooChow University
    • Suzhou 215004 China
    • First Affiliated Hospital, SooChow University
    • Suzhou 215006 China
    • The Second Hospital of Tianjin Medical University
    • Tianjin 300211 China
    • Wuhan Tongji Hospital, Tongji Medical College
    • Wuhan 430030 China
    • Wuxi People's Hospital
    • Wuxi 214023 China
    • First Affiliated Hospital, Xi'an Jiaotong University
    • Xi'An 710004 China
    • Fakultni nemocnice Hradec Kralove
    • Hradec Králove 500 05 Czechia
    • Krajská nemocnice Liberec
    • Liberec 460 63 Czechia
    • Nemocnice Novy Jicin a.s., oddeleni radioterapie a onkologie
    • Nový Jicin 741 01 Czechia
    • Urologicka klinika FNOL
    • Olomouc 775 20 Czechia
    • Slezska nemocnice v Opave
    • Opava 746 01 Czechia
    • Onkologicke Centrum Multiscan
    • Pardubice 532 03 Czechia
    • Fakultni nemocnice Kralovske Vinohrady
    • Praha 10 100 34 Czechia
    • Urocentrum Praha
    • Praha 2 120 00 Czechia
    • Urologicka klinika 1.LF UK a VFN
    • Praha 2 120 00 Czechia
    • Thomayerova nemocnice
    • Praha 4 140 59 Czechia
    • Urologicka klinika 2.LF UK a FN Motol
    • Praha 5 150 00 Czechia
    • Nemocnice Na Bulovce
    • Praha 8 180 00 Czechia
    • Krajska Nemocnice T. Bati a.s. (KNTB) - Ambulance Urologicka
    • Zlin 762 75 Czechia
    • CHU Gabriel-Montpied
    • Clermont Ferrand 63000 France
    • Institut du Cancer de Montpellier
    • Montpellier 34298 France
    • Centre d'oncologie de Gentilly
    • Nancy 54100 France
    • Institut Mutualiste Montsouris
    • Paris 75014 France
    • Hopital Europeen Georges-Pompidou
    • Paris 75015 France
    • Centre hospitalier Lyon-Sud
    • Pierre Bénite 69495 France
    • Strasbourg Oncologie Libérale
    • Strasbourg 67000 France
    • Hopital Foch
    • Suresnes 92151 France
    • Urologisches Zentrum Bonn
    • Bonn 53111 Germany
    • Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie
    • Braunschweig 38126 Germany
    • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
    • Hamburg 20246 Germany
    • Urologikum Hamburg
    • Hamburg 22399 Germany
    • Medizinische Hochschule Hannover
    • Hannover 30625 Germany
    • Praxis Dr. med. Silvio Szymula
    • Leipzig 04105 Germany
    • Universitätsklinikum Schleswig Holstein Campus Lübeck
    • Lubeck 23538 Germany
    • Praxis Dr. med. Ralf Eckert
    • Lutherstadt Eisleben 06295 Germany
    • Studienpraxis Urologie Nürtingen
    • Nürtingen 72622 Germany
    • Klinikverbund Südwest Medical Center Sindelfingen-Böblingen
    • Sindelfingen 71065 Germany
    • Klinikum St. Elisabeth Straubing GmbH
    • Straubing 94315 Germany
    • Semmelweis Egyetem, Urológia Klinika
    • Budapest 1082 Hungary
    • Egyesitett Szent Istvan Es Szent Laszlo Korhaz Rendelointezet
    • Budapest 1097 Hungary
    • Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
    • Budapest 1122 Hungary
    • Petz Aladar Megyei Oktato Korhaz
    • Győr 9023 Hungary
    • Uro-Clin Kft.
    • Pécs 7621 Hungary
    • Soproni Gyógyközpont, Urológia Osztály
    • Sopron 9400 Hungary
    • Soroka Medical Center
    • Beer Sheva 85101 Israel
    • Rambam Medical Center
    • Haifa 31096 Israel
    • Wolfson Medical Center
    • Holon 58100 Israel
    • Meir Medical Center
    • Kfar Saba 44281 Israel
    • Rabin Medical Center
    • Petach Tikva 49100 Israel
    • Sheba Medical Center
    • Ramat Gan 52621 Israel
    • Asaf Harofe Medical Center
    • Zrifin 60930 Israel
    • Chiba Cancer Center
    • Chuo-Ku, Chiba-City 260-8717 Japan
    • Harasanshin Hospital
    • Hakata-Ku 812-0033 Japan
    • Dokkyo Medical University Koshigaya Hospital
    • Koshigaya-Shi 343-8555 Japan
    • NHO Shikoku Cancer Center
    • Matsuyama 791-0280 Japan
    • Kitasato University Hospital
    • Minami-Ku, Sagamihara-Shi 252-0375 Japan
    • University of Miyazaki Hospital
    • Miyazaki 889-1692 Japan
    • Nagano Municipal Hospital
    • Nagano 381-8551 Japan
    • Nagasaki University Hospital
    • Nagasaki 852-8501 Japan
    • Kindai University Hospital
    • Osaka-Sayama 589-8511 Japan
    • Osaka International Cancer Institute
    • Osaka-Shi 541-8567 Japan
    • Toho University Sakura Medical Center
    • Sakura 285-8741 Japan
    • Hokkaido University Hospital
    • Sapporo 060-8648 Japan
    • Yokohama City University Medical Center
    • Yokohama 232-0024 Japan
    • Oita University Hospital
    • Yufu 879-5593 Japan
    • Kyungpook National University Chilgok Hospital
    • Daegu 702-210 Korea, Republic of
    • Chungnam National University Hospital
    • Daejeon 301-721 Korea, Republic of
    • National Cancer Center
    • Goyangsi 410 769 Korea, Republic of
    • Chonnam National University Hwasun Hospital
    • Hwasun-Gun 519-809 Korea, Republic of
    • Seoul National University Bundang Hospital
    • Seongnam 13605 Korea, Republic of
    • Seoul National University Hospital
    • Seoul 03080 Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Seoul 03722 Korea, Republic of
    • Gangnam Severance Hospital
    • Seoul 06273 Korea, Republic of
    • Seoul St. Mary's Hospital
    • Seoul 06591 Korea, Republic of
    • Samsung Medical Center
    • Seoul 135 710 Korea, Republic of
    • Korea University Hospital
    • Seoul 136 705 Korea, Republic of
    • Asan Medical Center
    • Seoul 138-736 Korea, Republic of
    • Instituto Metropolitano de Investigación Clínica S.C
    • Ciudad De México 14370 Mexico
    • Consultorio de Especialidad en Urologia Privado
    • Durango 34000 Mexico
    • Hospital Civil Fray Antonio Alcalde
    • Guadalajara 44280 Mexico
    • Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
    • Guadalajara 45030 Mexico
    • Hospital Aranda de la Parra S.A. de C.V.
    • Leon 37000 Mexico
    • Urología Multidisciplinaria S.C.
    • Mexico City 11950 Mexico
    • Centro Medico Nacional Siglo XXI IMSS
    • Mexico 06720 Mexico
    • Instituto Nacional de Cancerologia
    • Mexico 14080 Mexico
    • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
    • Mexico 14080 Mexico
    • Mexico Centre for Clinical Research, S.A. de C.V.
    • Mexico 3100 Mexico
    • Centro de Investigacion Clinica Chapultepec
    • Morelia 58260 Mexico
    • Hospital Central Militar
    • Naucalpan De Juárez 53950 Mexico
    • Investigacion Biomedica Aplicada de Hidalgo
    • Pachuca 42090 Mexico
    • Centro Oncologico Estatal ISSEMYM
    • Toluca 50180 Mexico
    • Consultorio Medico
    • Zapopan 45040 Mexico
    • Uniwersytecki Szpital Kliniczny Bialystok Klinika Urologii
    • Bialystok 15-276 Poland
    • Przychodnia Srodmiescie SP. z o.o.
    • Bydgoszcz 85-080 Poland
    • Szpital Uniwersytecki Nr 2 w Bydgoszczy
    • Bydgoszcz 85-168 Poland
    • Malopolskie Centrum Medyczne
    • Krakow 30-510 Poland
    • Szpital Specjalista Sp. z o.o
    • Kutno 99-300 Poland
    • Dermed Centrum Medyczne Sp. z o.o
    • Lodz 90-265 Poland
    • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
    • Lublin 20-718 Poland
    • Urologica Praktyka Lekarska Adam Marcheluk
    • Siedlce 08-110 Poland
    • ZOZ Szpitala Powiatowego w Sochaczewie
    • Sochaczew 96-500 Poland
    • Szpital Św. Elżbiety Mokotowskie Centrum Medyczne
    • Warszawa 02-616 Poland
    • Miedzyleski Szpital Specjalistyczny
    • Warszawa 04-749 Poland
    • Uromedica Wojciech Kolaczyk
    • Wroclaw 52-210 Poland
    • Baia Mare Emergency County Hospital
    • Baia-Mare 430031 Romania
    • Hyperclinica Medlife Grivita
    • Bucharest 010719 Romania
    • Fundeni Clinical Institute, Center for Uronephrology and Renal Transplantation
    • Bucharest 022328 Romania
    • Prof. Dr. Theodor Burghele Clinical Hospital
    • Bucharest 050659 Romania
    • Prof. Dr. Theodor Burghele Clinical Hospital
    • Bucharest 050659 Romania
    • Medisprof SRL
    • Cluj-Napoca 400058 Romania
    • SC Oncolab SRL
    • Craiova 200385 Romania
    • Spitalul Clinic Judetean Mures
    • Targu Mures 540141 Romania
    • Spitalul Clinic Municipal de Urgenta Timisoara
    • Timisoara 300594 Romania
    • Altai Regional Oncology Dispensary
    • Barnaul 656049 Russian Federation
    • Ivanovo Regional Oncology Dispensary
    • Ivanovo 153040 Russian Federation
    • FSBSI 'N. N. Blokhin Russian Cancer Research Center'
    • Moscow 115478 Russian Federation
    • Federal Scientific Clinical Center of Specialized Medical Care Medical Technologies FMBA
    • Moscow 115682 Russian Federation
    • Russian Scientific Center of Roentgenoradiology
    • Moscow 117997 Russian Federation
    • European Medical Center
    • Moscow 123104 Russian Federation
    • Moscow City Clinical Hospital # 62
    • Moscow 125130 Russian Federation
    • Botkin City Clinical Hospital
    • Moscow 125284 Russian Federation
    • Hertzen Oncology Research Institute
    • Moscow 125284 Russian Federation
    • Scientific Clinical Center ''RZD''
    • Moscow 125315 Russian Federation
    • Semashko Regional Clinical Hospital
    • Nizhny Novgorod 603126 Russian Federation
    • National Medical Radiological Research Center
    • Obninsk 249036 Russian Federation
    • Clinical Oncology Dispansary
    • Omsk 644013 Russian Federation
    • LLC Novaya Clinica
    • Pyatigorsk 357500 Russian Federation
    • Pyatigorsky Oncology Dispensary
    • Pyatigorsk 357502 Russian Federation
    • Hospital for War Veterans
    • Rostov-On-Don 344037 Russian Federation
    • Regional Clinical Oncology Dispensary
    • Ryazan 390011 Russian Federation
    • Leningrad Regional Oncology Dispensary
    • Saint-Petersburg 191104 Russian Federation
    • Republican Oncology Dispensary
    • Saransk 430032 Russian Federation
    • Regional Oncology Dispansary #2
    • Saratov 410053 Russian Federation
    • Oncologic Dispensary No.2
    • Sochi 354057 Russian Federation
    • St. Petersburg GBUZ City Hospital # 26
    • St Petersburg 196247 Russian Federation
    • Russian Scientific Center of Radiology and Surgical Technologies
    • St Petersburg 197758 Russian Federation
    • Komi Republic Oncology dispensary
    • Syktyvkar 167904 Russian Federation
    • Tambov Regional Oncology Clinical Dispansary
    • Tambov 392013 Russian Federation
    • Tomsk Regional Oncology Dispensary
    • Tomsk 634050 Russian Federation
    • Multifunctional clinical medical center 'Medical city'
    • Tyumen 625041 Russian Federation
    • Bashkiria State Medical University
    • Ufa 450000 Russian Federation
    • Vologda Regional Oncological Dispensary
    • Vologda 160012 Russian Federation
    • Fund. Puigvert
    • Barcelona 8025 Spain
    • Hosp. Reina Sofia
    • Cordoba 14004 Spain
    • Hospital Jerez De La Frontera
    • Jerez De La Frontera 11407 Spain
    • Hosp. Clinico San Carlos
    • Madrid 28040 Spain
    • Hosp. Univ. 12 de Octubre
    • Madrid 28041 Spain
    • Hosp. Univ. La Paz
    • Madrid 28046 Spain
    • Hospital Universitario Madrid Sanchinarro
    • Madrid 28050 Spain
    • Hosp. Univ. Infanta Sofia
    • Madrid 28702 Spain
    • Hosp. Univ. Fundacion Alcorcon
    • Madrid 28922 Spain
    • Clinica Univ. de Navarra
    • Pamplona 31008 Spain
    • Kliniska Prövningsenheten Urologmottagningen
    • Göteborg 413 45 Sweden
    • Urologiska Mottagningen
    • Malmö 205 02 Sweden
    • Urologiska kliniken
    • Stockholm 118 83 Sweden
    • Urologkliniken
    • Stockholm 171 76 Sweden
    • Urologkliniken
    • Umeå 901 85 Sweden
    • Urologiska kliniken
    • Uppsala 751 85 Sweden
    • Kirurgkliniken
    • Växjö 351 88 Sweden
    • Urologkliniken
    • Örebro 701 85 Sweden
    • Ankara University Medical Faculty
    • Ankara 06100 Turkey
    • Hacettepe University Medical Faculty
    • Ankara 06100 Turkey
    • Dışkapı Yıldırım Beyazıd Training and Research Hospital
    • Ankara 06110 Turkey
    • Gazi University Medical Faculty
    • Ankara 06560 Turkey
    • Ataturk Training and Research Hospital
    • Ankara 06800 Turkey
    • Trakya University Medical Faculty
    • Edirne 22030 Turkey
    • Istanbul University Cerrahpasa Medical Faculty
    • Istanbul 34098 Turkey
    • Ege Universitesi Tip Fakultesi
    • İzmir 35040 Turkey
    • Izmır Medical Park Hospital
    • İzmir 35580 Turkey
    • Mersin University Medical Faculty
    • Mersin 33343 Turkey
    • Cherkassy Regional Oncology Dispensary, Department of Hematology
    • Cherkasy 18009 Ukraine
    • Bukovinian State medical University, Chernivtsi regional clinical Hospital
    • Chernivtsi 58002 Ukraine
    • Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I.
    • Dnipo 49005 Ukraine
    • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
    • Dnipo 49102 Ukraine
    • Ivano Frankivsk National Medical University
    • Ivano-Frankivsk 76008 Ukraine
    • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
    • Kharkiv 61037 Ukraine
    • Municipal non-profit enterprise 'Regional Center of Oncology'
    • Kharkiv 61070 Ukraine
    • Khmelnitckiy regional hospital
    • Khmelnytsky 29000 Ukraine
    • Main military medical clinical centre
    • Kyiv 01133 Ukraine
    • Kyiv City Clinical Hospital #3
    • Kyiv 02660 Ukraine
    • State Institution National Cancer Institute
    • Kyiv 03022 Ukraine
    • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
    • Kyiv 03115 Ukraine
    • Lviv Clinical Regional Hospital
    • Lviv 79010 Ukraine
    • Lviv State Regional Oncology Medical and Diagnostic Center
    • Lviv 79031 Ukraine
    • Municipal institution 'City clinical hospital #10'
    • Odesa 65074 Ukraine
    • Ukrainian Medical Stomatological Academy
    • Poltava 36024 Ukraine
    • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
    • Uzhgorod 88000 Ukraine
    • Vinnitsa clinical oncology dispensary
    • Vinnitsa 21029 Ukraine
    • Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
    • Zaporizhzhya 69600 Ukraine
    • Cumberland Infirmary
    • Carlisle Ca2 7hy United Kingdom
    • Nhs Tayside
    • Dundee DD2 1UB United Kingdom
    • Beatson West Of Scotland Cancer Centre
    • Glasgow G12 0yn United Kingdom
    • Sarah Cannon Research Institute
    • London W1G 6AD United Kingdom
    • Freeman Hospital
    • Newcastle Upon Tyne NE7 7DN United Kingdom
    • Churchill Hospital
    • Oxford Ox3 7lq United Kingdom
    • Derriford Hospital
    • Plymouth PL6 8qh United Kingdom
    • Scunthorpe General Hospital
    • Scunthorpe DN15 7BH United Kingdom
    • University Hospital of North Tees
    • Stockton On Tees TS19 8PE United Kingdom
    • New Cross Hospital
    • Wolverhampton WV10 0QP United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair

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    A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair


    Condition: Prostate Cancer

    Intervention:

    • Drug: Olaparib
    • Drug: Durvalumab

    Purpose: The purpose of this study is to determine if the combination of olaparib and durvalumab are better than the standard of care for treating prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03810105

    Sponsor: Memorial Sloan Kettering Cancer Center

    Primary Outcome Measures:

    • Measure: Therapeutic efficacy as defined by number of participants with an undetectable PSA
    • Time Frame: 1 year
    • Safety Issue:

    Estimated Enrollment: 32

    Study Start Date: March 7, 2019

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
    • Males 18 years of age and above
    • Body weight > 30kg
    • History of radical prostatectomy
    • Histologically confirmed prostate cancer with progressive disease defined as:
    • Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential.
    • PSA doubling time of
    • No evidence of metastatic disease on conventional imaging (CT/MRI and bone scan). However, subjects with pelvic and/or retroperitoneal nodes < 2cm in the short axis will be permitted on study, as they are considered not to have definitive metastases. (Note: Metastatic disease on investigational imaging, Prostate Specific Membrane Antigen-targeted (PSMA) PET, PET-choline, or other novel PET tracers who do not have evidence of metastatic disease using conventional imaging (CT/MRI, bone scan) are allowed.)
    • Molecular evidence of DDR deleterious mutations (somatic or germline), including BRCA1, BRCA2, ATM, CHEK2, FANCA, RAD51C, RAD51D, PALB2, or CDK12. Mutations may be truncating, splice site mutations, missense or homozygous deletions. Mutation status is determined by a local laboratory with the result documented in the subject's medical record, previously obtained genomic testing from a CLIA-certified lab, or via archival or fresh tissue.
    • ECOG status of ≤1
    • Normal organ function with acceptable initial laboratory values within 14 days of treatment start:
    • WBC ≥ 2000/ul
    • ANC ≥ 1500/uL
    • Hemoglobin ≥ 10g/dL
    • Platelet count ≥100,000/ul
    • Creatinine Clearance ≥ 51 mL/min estimated using the Cockcroft-Gault equation
    • Bilirubin ≤ 1.5 ULN (unless documented Gilbert's disease)
    • SGOT (AST) ≤ 2.5 x ULN (unless liver metastases are present, in which case AST must be 5 x ULN)
    • SGPT (ALT) ≤ 2.5 x ULN (unless liver metastases are present, in which case ALT must be 5 x ULN)
    • Non-castrate level of testosterone defined as a value ≥ 150 ng/dL
    • Life expectancy of ≥ 52 weeks.
    • Agree to use two medically acceptable, highly effective forms of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 180 days after the last dose of study drug. Sperm donation is prohibited during the study and for 3 months after the last dose of study drug. Female partners of child bearing potential should use hormonal or barrier contraception unless postmenopausal or abstinent.

    Exclusion Criteria:

    • No other malignancy from which the subject has been disease-free for less than 3 years, with the exception of adequately treated and cured non-invasive malignancies such as basal or squamous cell skin cancer or superficial bladder cancer.
    • Less than one month prior to treatment start from last prior regimen or radiation exposure. Prior radiotherapy to the prostate (adjuvant or salvage radiotherapy) is allowed.
    • No prior investigational use with an anti-PD(1) including durvalumab or anti-CTLA4 antibody.
    • No prior treatment with a PARP inhibitor, including olaparib.
    • No concomitant or prior therapy with any of the following: IL-2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; or chronic use of systemic corticosteroids within 6 weeks of treatment start. Exceptions include: intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day ofprednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
    • No receipt of live attenuated vaccine within 30 days prior to treatment start Note: enrolled subjects should not receive live vaccine while receiving IP and up to 30 days after the last dose of study therapy
    • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to treatment start is 2 weeks.
    • Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
    • More than 2 cycles of intermittent hormones for the treatment of biochemical recurrence, with a cycle defined as a period of consistent ADT (generally 3-12 months) followed by intentional cessation of ADT without re-initiation of ADT until the PSA rises. Prior ADT in the treatment of localized prostate cancer or with salvage radiation therapy is allowed.
    • No medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous.
    • Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, myocardial infarction within 3 months of treatment start, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
    • No active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or active infection with human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
    • No autoimmune disease: subjects with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis *e.g., Sarcoidosis syndrome or Wegener's granulomatosis with polyangiitis+); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis); Graves' disease. Exceptions include history of eczema, vitiligo, alopecia, hypothyroidism (e.g., following Hashimoto syndrome) , and any chronic skin condition that does not require systemic therapy; subjects without active disease in the last 5 years prior to treatment start may be included but only after consultation with the treating physician. Exceptions may be made on a case by case basis upon discussion with the Sponsor Principal Investigator.
    • No history of active primary immunodeficiency
    • No major surgery within 4 weeks of treatment start. Subjects must have recovered from any significant effects of any major surgery but investigators may discuss with the Sponsor Principal Investigator in the case of any exceptions.
    • No blood transfusion within 28 days of treatment start.
    • Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
    • Enrollment in another clinical trial with a therapeutic agent. Subjects may co-enroll on investigational imaging studies (e.g., PSMA PET) or correlative trials.
    • No previous allogeneic bone marrow transplant or double umbilical cord blood transplant.
    • No history of leptomeningeal carcinomatosis
    • No unresolved toxicity (Common Terminology Criteria for Adverse Event (CTCAE) Grade >/= 2) caused by previous anticancer therapy, excluding alopecia, vitiligo, and the laboratory values described in the inclusion criteria. Subjects with Grade >/= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Sponsor Principal Investigator. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with study drugs may be included only after consultation with the Sponsor Principal Investigator
    • No subjects who are HIV-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with olaparib. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy.
    • No subjects with baseline moderate to severe hepatic impairment (Child-Pugh Class B and C).
    • No subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
    • No known allergy to any of the compounds under investigation or excipients of the product.
    • Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication.
    • No other condition which, in the opinion of the investigator, would preclude participation in this trial.

    Contact:

    • Karen Autio, MD, MSc
    • 646-422-4632

    Locations:

    • City of Hope Comprehensive Cancer Center
    • Duarte California 91010 United States
    • Wayne State University/Karmanos Cancer Institute
    • Detroit Michigan 48201 United States
    • Memoral Sloan Kettering Basking Ridge
    • Basking Ridge New Jersey 07920 United States
    • Memorial Sloan Kettering Bergen
    • Montvale New Jersey 07645 United States
    • Memorial Sloan Kettering Commack
    • Commack New York 11725 United States
    • Memoral Sloan Kettering Westchester
    • Harrison New York 10604 United States
    • Memorial Sloan - Kettering Cancer Center
    • New York New York 10021 United States

    View trial on ClinicalTrials.gov


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    Published August 19, 2019
  • A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)

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    A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)


    Condition: Prostate Cancer

    Intervention:

    • Drug: Rucaparib

    Purpose: This is a single arm, open label, phase II trial to assess efficacy of rucaparib.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03533946

    Sponsor: University of Utah

    Primary Outcome Measures:

    • Measure: 50% Reduction in PSA levels
    • Time Frame: Monthly while on treatment; Most patients are expected to be on treatment for approximately 18 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Adverse Events that Occur
    • Time Frame: Every visit while on treatment and 1 year of follow-up - Most patients are expected to be on treatment for approximately 18 months, and then one additional year
    • Safety Issue:
    • Measure: PSA Progression Free Survival
    • Time Frame: Monthly while on treatment; Most patients are expected to be on treatment for approximately 18 months
    • Safety Issue:
    • Measure: Proportion of patients with an undetectable PSA after initiation at therapy
    • Time Frame: At 6 and 12 months
    • Safety Issue:
    • Measure: Overall Survival
    • Time Frame: Every 3 months for 2 years after study discontinuation
    • Safety Issue:

    Estimated Enrollment: 29

    Study Start Date: August 8, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically proven adenocarcinoma of the prostate with BRCAness (defined as an alteration in one or more of the following genes: ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, ERCC3, FAM175A, FANCA, FANCL, GEN1, HDAC2, MLH1, MRE11, NBN, PALB2, PPP2R2A, RAD51, RAD54L) from soft-tissue based genomic testing or liquid biopsy based genomic testing.
    • ECOG/Zubrod score of 0-2.
    • Subjects must have received definitive local therapy, which includes prostatectomy or radiation therapy with curative intent. Neoadjuvant or adjuvant treatments can have been given within this time.
    • Subject must not have received any prior systemic therapy for localized prostate cancer unless used in the context of definitive local therapy. Patients may receive salvage hormone therapy with radiotherapy, as long as salvage hormone therapy does not exceed 6 months.
    • Be 18 years old at the time the informed consent form is signed.
    • Demonstrate adequate organ function as defined in the table in the protocol, all screening labs should be performed within 28 days of treatment initiation.
    • Highly effective barrier methods must be used with all sexual activity and contraception methods must be practiced for all subjects throughout the study and for at least 6 months after last rucaparib treatment administration if the risk of conception exists (section 7.2).
    • Recovery to baseline or Grade ≤ 1 CTCAE v5.0 from toxicities related to any prior treatments within the context of their definitive local therapy for their prostate cancer, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
    • Subject is able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

    Exclusion Criteria:

    • Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).
    • Subjects with metastases defined by conventional scans (CT, MRI, NM Bone Scan). Disease identified on molecular imaging (e.g. fluciclovine-PET) is not exclusionary.
    • Prior salvage therapy for prostate cancer treatment with chemotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or angiogenesis inhibitors.
    • Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months prior to screening.
    • Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib.
    • Inability to swallow tablets.
    • Evidence or history of bleeding disorder.
    • Participation in another investigational drug trial within 14 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1.
    • Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1, unless mild in severity and approved by the Principal Investigator.
    • Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured or with a prolonged natural history (e.g estimated overall survival > 5 years).
    • Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide, or any platinum based chemotherapy.
    • Clinically significant (i.e., active) cardiovascular disease at the time of enrollment: congestive heart failure (> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
    • Other severe acute or chronic medical conditions including cardiovascular, endocrine, neurologic, pulmonary or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    • Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 28 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

    Contact:

    • Jill Broghammer
    • 801-213-6232

    Location:

    • Huntsman Cancer Institute
    • Salt Lake City Utah 84112 United States

    View trial on ClinicalTrials.gov


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    Published January 7, 2019
  • A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer

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    A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer


    Condition: Prostate Cancer, Prostate Adenocarcinoma

    Intervention:

    • Drug: ADT+Docetaxel+Enzalutamide

    Purpose: This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03246347

    Sponsor: Earle Burgess

    Primary Outcome Measures:

    • Measure: PSA complete response rate
    • Time Frame: 12 month
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Serologic response rate
    • Time Frame: Duration of study participation, an average of 2 years
    • Safety Issue:
    • Measure: Radiographic response rate
    • Time Frame: Duration of study participation, an average of 2-3 years
    • Safety Issue:
    • Measure: Time to castrate resistance
    • Time Frame: Duration of study participation, an average of 2 years
    • Safety Issue:
    • Measure: serologic progression free survival
    • Time Frame: Duration of study participation, an average of 2 years
    • Safety Issue:
    • Measure: radiographic progression free survival
    • Time Frame: Duration of study participation, an average of 2-3 years
    • Safety Issue:
    • Measure: overall survival
    • Time Frame: Duration of study participation, an average of 5 years
    • Safety Issue:
    • Measure: time to treatment failure
    • Time Frame: Duration of study participation, an average of 2-3 years
    • Safety Issue:
    • Measure: Treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: Duration of study participation, an average of 5 years
    • Safety Issue:

    Estimated Enrollment: 39

    Study Start Date: August 21, 2017

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation. Metastatic disease must be present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment. If the subject has regional lymph node involvement, there must be at least one additional site of disease including visceral, non-regional nodal or skeletal metastases.
    • ADT with surgical castration with bilateral orchiectomy or medical castration with LHRH agonist or LHRH antagonist therapy may have been initiated no greater than 112 days (16 weeks) prior to enrollment date. Subjects who initiated ADT prior to consent, are not eligible if PSA has risen ≥ 25% and ≥ 2 ng/ml above nadir value since initiation of ADT prior to consent.
    • At least one PSA level of ≥ 5 ng/ml within 90 days prior to consent.
    • Prior ADT for non-metastatic disease with LHRH agonist or LHRH antagonist therapy in the neoadjuvant/adjuvant setting is permitted if: 1. Total duration of therapy did not exceed 36 months 2. 6 months have elapsed since completion of therapy prior to consent, 3. Serum testosterone > 50 ng/dl within 28 days prior to reinitiation of ADT for metastatic disease 4. Prior ADT for non-metastatic disease must have accompanied definitive local therapy for curative intent.
    • Age ≥ 18 years.
    • ECOG performance status 0-2.
    • Adequate liver function: AST and ALT <1.5x upper limit of normal, total bilirubin < 1x upper limit of normal.
    • Adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 8.0g/dL and ANC > 1,500 cells/mm3.
    • Adequate renal function with a creatinine clearance (based on Cockcroft-Gault formula) ≥ 30 mL/min.
    • Ability to understand and the willingness to sign a written informed consent document.
    • Able to swallow and retain oral medication

    Exclusion Criteria:

    • Personal history of seizure.
    • Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
    • Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
    • Personal history of any condition that may impair absorption of enzalutamide.
    • Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
    • Prior therapy with bicalutamide, nilutamide or flutamide within 14 days of enrollment.
    • Within 28 days of major surgery and/or lack of recovery from prior surgical procedure or 14 days of palliative radiation prior to enrollment.
    • Prior or current therapy with an investigational agent for metastatic prostate cancer.
    • Known hypersensitivity to drugs formulated with polysorbate 80.
    • Personal history of posterior reversible encephalopathy syndrome.
    • CTCAE version 4.0 grade 2-4 peripheral sensory neuropathy.
    • Human immunodeficiency virus infection or active hepatitis B or C infection.
    • Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
    • Presence of any of the following within the previous 3 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
    • History of an additional active malignancy within 12 months prior to the date of consent (except non-melanoma skin cancer).
    • Current use of strong CYP2C8 inhibitors, CYP3A4 inducers or CYP3A4, CYP2C9 or CYP2C19 substrates with a narrow therapeutic range as listed in Section 7.2.1.
    • Any condition that requires the use of prednisone > 10mg daily, or equivalent daily glucocorticoid dose, for greater than 14 days

    Contact:

    • Sandra Samu-Arce, RN
    • 980-993-5484

    Location:

    • Levine Cancer Institute
    • Charlotte North Carolina 28204 United States

    View trial on ClinicalTrials.gov


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    Published October 16, 2017
  • A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

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    A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: TAK-700
    • Drug: Bicalutamide

    Purpose: The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01809691

    Sponsor: Southwest Oncology Group

    Primary Outcome Measures:

    • Measure: Overall survival
    • Time Frame: 3.2 years
    • Safety Issue:

    Estimated Enrollment: 1304

    Study Start Date: March 2013

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Clinical diagnosis of metastatic prostate cancer.
    • Serum testosterone within institutional limits of normal.
    • PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
    • DEXA scan within 2 years prior to registration.
    • ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
    • LVEF within 42 days prior to registration and within institutional limits of normal.
    • Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
    • Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
    • Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
    • Zubrod performance status of 0
    • 2. Zubrod performance status 3 will be allowed if from bone pain only.
    • ≥ 18 years of age.
    • Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

    Exclusion Criteria:

    • Known brain metastases.
    • No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
    • ≥ 6 months since completion of androgen deprivation therapy.
    • Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
    • Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
    • ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
    • Concurrent use of experimental therapy is not allowed.
    • ≥ 30 days since prior medical castration for metastatic prostate cancer.
    • If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
    • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
    • Prior bilateral orchiectomy.
    • Concurrent use of LHRH antagonists (e.g. Degarelix)
    • Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
    • Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
    • Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
    • History of primary and secondary adrenal insufficiency.
    • Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
    • Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

    Contact:

    • Nicki Trevino
    • 614-8808 Ext. 1007

    Locations:

    • Veterans Administration Medical Center - Birmingham
    • Birmingham Alabama 35233 United States
    • University of Arizona Cancer Center at Saint Joseph's
    • Phoenix Arizona 85004 United States
    • University of Arizona Cancer Center-Orange Grove Campus
    • Tucson Arizona 85704 United States
    • University of Arizona Cancer Center-North Campus
    • Tucson Arizona 85719 United States
    • Southern Arizona Veterans Affairs Health Center
    • Tucson Arizona 85723 United States
    • The University of Arizona Medical Center-University Campus
    • Tucson Arizona 85724 United States
    • Fowler Family Center for Cancer Care
    • Jonesboro Arkansas 72401 United States
    • Veteran's Administration Medical Center
    • Little Rock Arkansas 72205 United States
    • Kaiser Permanente-Deer Valley Medical Center
    • Antioch California 94531 United States
    • Sutter Auburn Faith Hospital
    • Auburn California 95602 United States
    • AIS Cancer Center at San Joaquin Community Hospital
    • Bakersfield California 93301 United States
    • Alta Bates Summit Medical Center-Herrick Campus
    • Berkeley California 94704 United States
    • Mills - Peninsula Hospitals
    • Burlingame California 94010 United States
    • City of Hope Corona
    • Corona California 92879 United States
    • Sutter Davis Hospital
    • Davis California 95616 United States
    • City of Hope Comprehensive Cancer Center
    • Duarte California 91010 United States
    • Kaiser Permanente-Fremont
    • Fremont California 94538 United States
    • University Oncology Associates
    • Fresno California 93701 United States
    • Kaiser Permanente
    • Fresno California 93720 United States
    • UC San Diego Moores Cancer Center
    • La Jolla California 92093 United States
    • Loma Linda University Medical Center
    • Loma Linda California 92354 United States
    • Veterans Affairs Loma Linda Healthcare System
    • Loma Linda California 92357 United States
    • Los Angeles County-USC Medical Center
    • Los Angeles California 90033 United States
    • USC / Norris Comprehensive Cancer Center
    • Los Angeles California 90033 United States
    • Fremont - Rideout Cancer Center
    • Marysville California 95901 United States
    • Mather Veteran Affairs Medical Center
    • Mather California 95655 United States
    • Mercy UC Davis Cancer Center
    • Merced California 95340 United States
    • Memorial Medical Center
    • Modesto California 95355 United States
    • Kaiser Permanente-Modesto
    • Modesto California 95356 United States
    • Palo Alto Medical Foundation-Camino Division
    • Mountain View California 94040 United States
    • Palo Alto Medical Foundation-Gynecologic Oncology
    • Mountain View California 94040 United States
    • USC Norris Oncology/Hematology-Newport Beach
    • Newport Beach California 92663 United States
    • Sutter Cancer Research Consortium
    • Novato California 94945 United States
    • Kaiser Permanente-Oakland
    • Oakland California 94611 United States
    • UC Irvine Health/Chao Family Comprehensive Cancer Center
    • Orange California 92868 United States
    • Palo Alto Medical Foundation Health Care
    • Palo Alto California 94301 United States
    • Feather River Cancer Center
    • Paradise California 95969 United States
    • Keck Medical Center of USC Pasadena
    • Pasadena California 91105 United States
    • PCR Oncology
    • Pismo Beach California 93449 United States
    • Kaiser Permanente-Redwood City
    • Redwood City California 94063 United States
    • Kaiser Permanente-Richmond
    • Richmond California 94801 United States
    • Kaiser Permanente-Roseville
    • Roseville California 95661 United States
    • Sutter Roseville Medical Center
    • Roseville California 95661 United States
    • Sutter General Hospital
    • Sacramento California 95816 United States
    • University of California Davis Comprehensive Cancer Center
    • Sacramento California 95817 United States
    • Kaiser Permanente-South Sacramento
    • Sacramento California 95823 United States
    • Kaiser Permanente - Sacramento
    • Sacramento California 95825 United States
    • Saint Helena Hospital
    • Saint Helena California 94574 United States
    • California Pacific Medical Center-Pacific Campus
    • San Francisco California 94115 United States
    • Kaiser Permanente-San Francisco
    • San Francisco California 94115 United States
    • UCSF Medical Center-Mount Zion
    • San Francisco California 94115 United States
    • UCSF Medical Center-Mission Bay
    • San Francisco California 94158 United States
    • Kaiser Permanente-Santa Teresa-San Jose
    • San Jose California 95119 United States
    • Kaiser Permanente San Leandro
    • San Leandro California 94577 United States
    • Kaiser Permanente-San Rafael
    • San Rafael California 94903 United States
    • Kaiser Permanente Medical Center - Santa Clara
    • Santa Clara California 95051 United States
    • Palo Alto Medical Foundation-Santa Cruz
    • Santa Cruz California 95065 United States
    • Kaiser Permanente-Santa Rosa
    • Santa Rosa California 95403 United States
    • Sutter Pacific Medical Foundation
    • Santa Rosa California 95403 United States
    • Kaiser Permanente-South San Francisco
    • South San Francisco California 94080 United States
    • Kaiser Permanente-Stockton
    • Stockton California 95210 United States
    • Palo Alto Medical Foundation-Sunnyvale
    • Sunnyvale California 94086 United States
    • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Truckee California 96161 United States
    • Northbay Cancer Center
    • Vacaville California 95687 United States
    • Kaiser Permanente Medical Center-Vacaville
    • Vacaville California 95688 United States
    • Kaiser Permanente-Vallejo
    • Vallejo California 94589 United States
    • Sutter Solano Medical Center/Cancer Center
    • Vallejo California 94589 United States
    • Kaiser Permanente-Walnut Creek
    • Walnut Creek California 94596 United States
    • Rocky Mountain Cancer Centers-Aurora
    • Aurora Colorado 80012 United States
    • The Medical Center of Aurora
    • Aurora Colorado 80012 United States
    • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    • Aurora Colorado 80045 United States
    • Boulder Community Hospital
    • Boulder Colorado 80301 United States
    • Rocky Mountain Cancer Centers-Boulder
    • Boulder Colorado 80304 United States
    • Penrose-Saint Francis Healthcare
    • Colorado Springs Colorado 80907 United States
    • Rocky Mountain Cancer Centers-Penrose
    • Colorado Springs Colorado 80907 United States
    • Porter Adventist Hospital
    • Denver Colorado 80210 United States
    • Colorado Blood Cancer Institute
    • Denver Colorado 80218 United States
    • Presbyterian - Saint Lukes Medical Center - Health One
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Midtown
    • Denver Colorado 80218 United States
    • SCL Health Saint Joseph Hospital
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Rose
    • Denver Colorado 80220 United States
    • Rose Medical Center
    • Denver Colorado 80220 United States
    • Colorado Cancer Research Program NCORP
    • Denver Colorado 80222 United States
    • Mercy Medical Center
    • Durango Colorado 81301 United States
    • Southwest Oncology PC
    • Durango Colorado 81301 United States
    • Comprehensive Cancer Care and Research Institute of Colorado LLC
    • Englewood Colorado 80113 United States
    • Swedish Medical Center
    • Englewood Colorado 80113 United States
    • Mountain Blue Cancer Care Center
    • Golden Colorado 80401 United States
    • North Colorado Medical Center
    • Greeley Colorado 80631 United States
    • Rocky Mountain Cancer Centers-Greenwood Village
    • Greenwood Village Colorado 80111 United States
    • Rocky Mountain Cancer Centers-Lakewood
    • Lakewood Colorado 80228 United States
    • Saint Anthony Hospital
    • Lakewood Colorado 80228 United States
    • Rocky Mountain Cancer Centers-Littleton
    • Littleton Colorado 80120 United States
    • Littleton Adventist Hospital
    • Littleton Colorado 80122 United States
    • Rocky Mountain Cancer Centers-Sky Ridge
    • Lone Tree Colorado 80124 United States
    • Sky Ridge Medical Center
    • Lone Tree Colorado 80124 United States
    • Longmont United Hospital
    • Longmont Colorado 80501 United States
    • Rocky Mountain Cancer Centers-Longmont
    • Longmont Colorado 80501 United States
    • McKee Medical Center
    • Loveland Colorado 80539 United States
    • Parker Adventist Hospital
    • Parker Colorado 80138 United States
    • Rocky Mountain Cancer Centers-Parker
    • Parker Colorado 80138 United States
    • Saint Mary Corwin Medical Center
    • Pueblo Colorado 81004 United States
    • Rocky Mountain Cancer Centers - Pueblo
    • Pueblo Colorado 81008 United States
    • Rocky Mountain Cancer Centers-Thornton
    • Thornton Colorado 80260 United States
    • SCL Health Lutheran Medical Center
    • Wheat Ridge Colorado 80033 United States
    • Greenwich Hospital
    • Greenwich Connecticut 06830 United States
    • Yale University
    • New Haven Connecticut 06520 United States
    • Eastern Connecticut Hematology and Oncology Associates
    • Norwich Connecticut 06360 United States
    • Stamford Hospital/Bennett Cancer Center
    • Stamford Connecticut 06904 United States
    • Beebe Medical Center
    • Lewes Delaware 19958 United States
    • Medical Oncology Hematology Consultants PA
    • Newark Delaware 19713 United States
    • Regional Hematology and Oncology PA
    • Newark Delaware 19713 United States
    • Christiana Care Health System-Christiana Hospital
    • Newark Delaware 19718 United States
    • Nanticoke Memorial Hospital
    • Seaford Delaware 19973 United States
    • MedStar Georgetown University Hospital
    • Washington, D.C. District of Columbia 20007 United States
    • MedStar Washington Hospital Center
    • Washington, D.C. District of Columbia 20010 United States
    • Sibley Memorial Hospital
    • Washington, D.C. District of Columbia 20016 United States
    • George Washington University Medical Center
    • Washington, D.C. District of Columbia 20037 United States
    • Veterans Affairs Medical Center -Washington DC
    • Washington, D.C. District of Columbia 20422 United States
    • Broward Health Medical Center
    • Fort Lauderdale Florida 33316 United States
    • Lakeland Regional Health Hollis Cancer Center
    • Lakeland Florida 33805 United States
    • Florida Hospital Orlando
    • Orlando Florida 32803 United States
    • UF Cancer Center at Orlando Health
    • Orlando Florida 32806 United States
    • Moffitt Cancer Center
    • Tampa Florida 33612 United States
    • John B Amos Cancer Center
    • Columbus Georgia 31904 United States
    • Atlanta VA Medical Center
    • Decatur Georgia 30033 United States
    • Northeast Georgia Medical Center-Gainesville
    • Gainesville Georgia 30501 United States
    • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Savannah Georgia 31405 United States
    • Hawaii Oncology Inc-Pali Momi
    • 'Aiea Hawaii 96701 United States
    • Hawaii Cancer Care Inc-POB II
    • Honolulu Hawaii 96813 United States
    • Queen's Medical Center
    • Honolulu Hawaii 96813 United States
    • University of Hawaii Cancer Center
    • Honolulu Hawaii 96813 United States
    • Hawaii Cancer Care Inc-Liliha
    • Honolulu Hawaii 96817 United States
    • Hawaii Oncology Inc-Kuakini
    • Honolulu Hawaii 96817 United States
    • Kaiser Permanente Moanalua Medical Center
    • Honolulu Hawaii 96819 United States
    • Tripler Army Medical Center
    • Honolulu Hawaii 96859 United States
    • Saint Alphonsus Cancer Care Center-Boise
    • Boise Idaho 83706 United States
    • Kootenai Medical Center
    • Coeur d'Alene Idaho 83814 United States
    • Kootenai Cancer Center
    • Post Falls Idaho 83854 United States
    • Kootenai Cancer Clinic
    • Sandpoint Idaho 83864 United States
    • Rush - Copley Medical Center
    • Aurora Illinois 60504 United States
    • Saint Joseph Medical Center
    • Bloomington Illinois 61701 United States
    • Illinois CancerCare-Bloomington
    • Bloomington Illinois 61704 United States
    • Illinois CancerCare-Canton
    • Canton Illinois 61520 United States
    • Illinois CancerCare-Carthage
    • Carthage Illinois 62321 United States
    • Centralia Oncology Clinic
    • Centralia Illinois 62801 United States
    • Mount Sinai Hospital Medical Center
    • Chicago Illinois 60608 United States
    • Northwestern University
    • Chicago Illinois 60611 United States
    • University of Illinois
    • Chicago Illinois 60612 United States
    • University of Chicago Comprehensive Cancer Center
    • Chicago Illinois 60637 United States
    • Weiss Memorial Hospital
    • Chicago Illinois 60640 United States
    • Presence Saint Joseph Hospital-Chicago
    • Chicago Illinois 60657 United States
    • Cancer Care Center of Decatur
    • Decatur Illinois 62526 United States
    • Decatur Memorial Hospital
    • Decatur Illinois 62526 United States
    • Heartland Cancer Research NCORP
    • Decatur Illinois 62526 United States
    • Crossroads Cancer Center
    • Effingham Illinois 62401 United States
    • Illinois CancerCare-Eureka
    • Eureka Illinois 61530 United States
    • NorthShore University HealthSystem-Evanston Hospital
    • Evanston Illinois 60201 United States
    • Illinois CancerCare-Galesburg
    • Galesburg Illinois 61401 United States
    • Northwestern Medicine Cancer Center Delnor
    • Geneva Illinois 60134 United States
    • NorthShore University HealthSystem-Glenbrook Hospital
    • Glenview Illinois 60026 United States
    • NorthShore University HealthSystem-Highland Park Hospital
    • Highland Park Illinois 60035 United States
    • Hines Veterans Administration Hospital
    • Hines Illinois 60141 United States
    • Joliet Oncology-Hematology Associates Limited
    • Joliet Illinois 60435 United States
    • Presence Saint Mary's Hospital
    • Kankakee Illinois 60901 United States
    • Illinois CancerCare-Kewanee Clinic
    • Kewanee Illinois 61443 United States
    • Illinois CancerCare-Macomb
    • Macomb Illinois 61455 United States
    • Loyola University Medical Center
    • Maywood Illinois 60153 United States
    • Trinity Medical Center
    • Moline Illinois 61265 United States
    • Illinois CancerCare-Monmouth
    • Monmouth Illinois 61462 United States
    • Community Cancer Center Foundation
    • Normal Illinois 61761 United States
    • Illinois CancerCare-Ottawa Clinic
    • Ottawa Illinois 61350 United States
    • Ottawa Regional Hospital and Healthcare Center
    • Ottawa Illinois 61350 United States
    • Illinois CancerCare-Pekin
    • Pekin Illinois 61554 United States
    • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    • Pekin Illinois 61554 United States
    • Methodist Medical Center of Illinois
    • Peoria Illinois 61603 United States
    • Proctor Hospital
    • Peoria Illinois 61614 United States
    • Illinois CancerCare-Peoria
    • Peoria Illinois 61615 United States
    • OSF Saint Francis Medical Center
    • Peoria Illinois 61637 United States
    • Illinois CancerCare-Peru
    • Peru Illinois 61354 United States
    • Illinois CancerCare-Princeton
    • Princeton Illinois 61356 United States
    • West Suburban Medical Center
    • River Forest Illinois 60305 United States
    • SwedishAmerican Regional Cancer Center/ACT
    • Rockford Illinois 61114 United States
    • Southern Illinois University School of Medicine
    • Springfield Illinois 62702 United States
    • Springfield Clinic
    • Springfield Illinois 62702 United States
    • Memorial Medical Center
    • Springfield Illinois 62781 United States
    • Cancer Care Specialists of Illinois-Swansea
    • Swansea Illinois 62226 United States
    • Carle Cancer Center
    • Urbana Illinois 61801 United States
    • Northwestern Medicine Cancer Center Warrenville
    • Warrenville Illinois 60555 United States
    • Rush-Copley Healthcare Center
    • Yorkville Illinois 60560 United States
    • IU Health Bloomington
    • Bloomington Indiana 47403 United States
    • Memorial Regional Cancer Center Day Road
    • Mishawaka Indiana 46545 United States
    • Memorial Hospital of South Bend
    • South Bend Indiana 46601 United States
    • Porter Memorial Hospital
    • Valparaiso Indiana 46383 United States
    • McFarland Clinic PC-William R Bliss Cancer Center
    • Ames Iowa 50010 United States
    • Mercy Hospital
    • Cedar Rapids Iowa 52403 United States
    • Oncology Associates at Mercy Medical Center
    • Cedar Rapids Iowa 52403 United States
    • Medical Oncology and Hematology Associates-West Des Moines
    • Clive Iowa 50325 United States
    • Alegent Health Mercy Hospital
    • Council Bluffs Iowa 51503 United States
    • Genesis Medical Center - East Campus
    • Davenport Iowa 52803 United States
    • Medical Oncology and Hematology Associates-Laurel
    • Des Moines Iowa 50314 United States
    • Mercy Medical Center - Des Moines
    • Des Moines Iowa 50314 United States
    • University of Iowa/Holden Comprehensive Cancer Center
    • Iowa City Iowa 52242 United States
    • Iowa City VA Healthcare System
    • Iowa City Iowa 52246 United States
    • Cancer Center of Kansas - Chanute
    • Chanute Kansas 66720 United States
    • Cancer Center of Kansas - Dodge City
    • Dodge City Kansas 67801 United States
    • Cancer Center of Kansas - El Dorado
    • El Dorado Kansas 67042 United States
    • Cancer Center of Kansas - Fort Scott
    • Fort Scott Kansas 66701 United States
    • Saint Catherine Hospital
    • Garden City Kansas 67846 United States
    • Heartland Cancer Center
    • Great Bend Kansas 67530 United States
    • Saint Rose Ambulatory and Surgery Center
    • Great Bend Kansas 67530 United States
    • Hays Medical Center
    • Hays Kansas 67601 United States
    • Cancer Center of Kansas-Independence
    • Independence Kansas 67301 United States
    • University of Kansas Cancer Center-West
    • Kansas City Kansas 66112 United States
    • University of Kansas Cancer Center
    • Kansas City Kansas 66160 United States
    • Cancer Center of Kansas-Kingman
    • Kingman Kansas 67068 United States
    • Lawrence Memorial Hospital
    • Lawrence Kansas 66044 United States
    • Cancer Center of Kansas-Liberal
    • Liberal Kansas 67905 United States
    • Cancer Center of Kansas-Manhattan
    • Manhattan Kansas 66502 United States
    • Cancer Center of Kansas - McPherson
    • McPherson Kansas 67460 United States
    • Cancer Center of Kansas - Newton
    • Newton Kansas 67114 United States
    • Olathe Medical Center
    • Olathe Kansas 66061 United States
    • Menorah Medical Center
    • Overland Park Kansas 66209 United States
    • University of Kansas Cancer Center-Overland Park
    • Overland Park Kansas 66210 United States
    • Cancer Center of Kansas - Parsons
    • Parsons Kansas 67357 United States
    • Cancer Center of Kansas - Pratt
    • Pratt Kansas 67124 United States
    • Cancer Center of Kansas - Salina
    • Salina Kansas 67401 United States
    • Salina Regional Health Center
    • Salina Kansas 67401 United States
    • Cotton O'Neil Cancer Center / Stormont Vail Health
    • Topeka Kansas 66606 United States
    • Saint Francis Hospital and Medical Center - Topeka
    • Topeka Kansas 66606 United States
    • Topeka VA Hospital
    • Topeka Kansas 66622 United States
    • Cancer Center of Kansas - Wellington
    • Wellington Kansas 67152 United States
    • Associates In Womens Health
    • Wichita Kansas 67208 United States
    • Cancer Center of Kansas-Wichita Medical Arts Tower
    • Wichita Kansas 67208 United States
    • Cancer Center of Kansas - Wichita
    • Wichita Kansas 67214 United States
    • Via Christi Regional Medical Center
    • Wichita Kansas 67214 United States
    • Wichita NCI Community Oncology Research Program
    • Wichita Kansas 67214 United States
    • Cancer Center of Kansas - Winfield
    • Winfield Kansas 67156 United States
    • University of Kentucky/Markey Cancer Center
    • Lexington Kentucky 40536 United States
    • Hematology/Oncology Clinic LLP
    • Baton Rouge Louisiana 70809 United States
    • Ochsner Health Center-Summa
    • Baton Rouge Louisiana 70809 United States
    • Ochsner Medical Center Kenner
    • Kenner Louisiana 70065 United States
    • East Jefferson General Hospital
    • Metairie Louisiana 70006 United States
    • Louisiana State University Health Science Center
    • New Orleans Louisiana 70112 United States
    • Tulane University Health Sciences Center
    • New Orleans Louisiana 70112 United States
    • University Medical Center New Orleans
    • New Orleans Louisiana 70112 United States
    • Ochsner Medical Center Jefferson
    • New Orleans Louisiana 70121 United States
    • Louisiana State University Health Sciences Center Shreveport
    • Shreveport Louisiana 71103 United States
    • Harold Alfond Center for Cancer Care
    • Augusta Maine 04330 United States
    • Eastern Maine Medical Center
    • Bangor Maine 04401 United States
    • Penobscot Bay Medical Center
    • Rockport Maine 04856 United States
    • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Baltimore Maryland 21287 United States
    • Montgomery General Hospital-Olney
    • Olney Maryland 20832 United States
    • Boston Medical Center
    • Boston Massachusetts 02118 United States
    • Dana-Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Steward Saint Elizabeth's Medical Center
    • Brighton Massachusetts 02135 United States
    • Lahey Hospital and Medical Center
    • Burlington Massachusetts 01805 United States
    • Saint Anne's Hospital
    • Fall River Massachusetts 02721 United States
    • Dana Farber Community Cancer Care-Quincy
    • Quincy Massachusetts 02169 United States
    • Baystate Medical Center
    • Springfield Massachusetts 01199 United States
    • Hickman Cancer Center
    • Adrian Michigan 49221 United States
    • Saint Joseph Mercy Hospital
    • Ann Arbor Michigan 48106-0995 United States
    • Michigan Cancer Research Consortium NCORP
    • Ann Arbor Michigan 48106 United States
    • University of Michigan Comprehensive Cancer Center
    • Ann Arbor Michigan 48109 United States
    • Bronson Battle Creek
    • Battle Creek Michigan 49017 United States
    • IHA Hematology Oncology Consultants-Brighton
    • Brighton Michigan 48114 United States
    • Saint Joseph Mercy Brighton
    • Brighton Michigan 48114 United States
    • IHA Hematology Oncology Consultants-Canton
    • Canton Michigan 48188 United States
    • Saint Joseph Mercy Canton Health Center
    • Canton Michigan 48188 United States
    • IHA Hematology Oncology Consultants-Chelsea
    • Chelsea Michigan 48118 United States
    • Saint Joseph Mercy Chelsea
    • Chelsea Michigan 48118 United States
    • Saint John Hospital and Medical Center
    • Detroit Michigan 48236 United States
    • Green Bay Oncology - Escanaba
    • Escanaba Michigan 49829 United States
    • Botsford General Hospital
    • Farmington Michigan 48334 United States
    • Cancer Research Consortium of West Michigan NCORP
    • Grand Rapids Michigan 49503 United States
    • Mercy Health Saint Mary's
    • Grand Rapids Michigan 49503 United States
    • Spectrum Health at Butterworth Campus
    • Grand Rapids Michigan 49503 United States
    • Green Bay Oncology - Iron Mountain
    • Iron Mountain Michigan 49801 United States
    • West Michigan Cancer Center
    • Kalamazoo Michigan 49007 United States
    • Sparrow Hospital
    • Lansing Michigan 48912 United States
    • Mercy Health Mercy Campus
    • Muskegon Michigan 49444 United States
    • Lakeland Community Hospital
    • Niles Michigan 49120 United States
    • Saint Joseph Mercy Oakland
    • Pontiac Michigan 48341 United States
    • Lake Huron Medical Center
    • Port Huron Michigan 48060 United States
    • Spectrum Health Reed City Hospital
    • Reed City Michigan 49677 United States
    • William Beaumont Hospital-Royal Oak
    • Royal Oak Michigan 48073 United States
    • Saint Mary's of Michigan
    • Saginaw Michigan 48601 United States
    • Marie Yeager Cancer Center
    • Saint Joseph Michigan 49085 United States
    • Munson Medical Center
    • Traverse City Michigan 49684 United States
    • William Beaumont Hospital - Troy
    • Troy Michigan 48098 United States
    • Saint John Macomb-Oakland Hospital
    • Warren Michigan 48093 United States
    • IHA Hematology Oncology Consultants-Ann Arbor
    • Ypsilanti Michigan 48197 United States
    • Sanford Clinic North-Bemidgi
    • Bemidji Minnesota 56601 United States
    • Fairview Ridges Hospital
    • Burnsville Minnesota 55337 United States
    • Mercy Hospital
    • Coon Rapids Minnesota 55433 United States
    • Essentia Health Cancer Center
    • Duluth Minnesota 55805 United States
    • Fairview-Southdale Hospital
    • Edina Minnesota 55435 United States
    • Lake Region Healthcare Corporation-Cancer Care
    • Fergus Falls Minnesota 56537 United States
    • Unity Hospital
    • Fridley Minnesota 55432 United States
    • Minnesota Oncology Hematology PA-Maplewood
    • Maplewood Minnesota 55109 United States
    • Saint John's Hospital - Healtheast
    • Maplewood Minnesota 55109 United States
    • Abbott-Northwestern Hospital
    • Minneapolis Minnesota 55407 United States
    • Hennepin County Medical Center
    • Minneapolis Minnesota 55415 United States
    • Minneapolis Veterans Medical Center
    • Minneapolis Minnesota 55417 United States
    • Health Partners Inc
    • Minneapolis Minnesota 55454 United States
    • University of Minnesota/Masonic Cancer Center
    • Minneapolis Minnesota 55455 United States
    • North Memorial Medical Health Center
    • Robbinsdale Minnesota 55422 United States
    • Mayo Clinic
    • Rochester Minnesota 55905 United States
    • Coborn Cancer Center at Saint Cloud Hospital
    • Saint Cloud Minnesota 56303 United States
    • Metro Minnesota Community Oncology Research Consortium
    • Saint Louis Park Minnesota 55416 United States
    • Park Nicollet Clinic - Saint Louis Park
    • Saint Louis Park Minnesota 55416 United States
    • Regions Hospital
    • Saint Paul Minnesota 55101 United States
    • United Hospital
    • Saint Paul Minnesota 55102 United States
    • Saint Francis Regional Medical Center
    • Shakopee Minnesota 55379 United States
    • Lakeview Hospital
    • Stillwater Minnesota 55082 United States
    • Ridgeview Medical Center
    • Waconia Minnesota 55387 United States
    • Rice Memorial Hospital
    • Willmar Minnesota 56201 United States
    • Minnesota Oncology Hematology PA-Woodbury
    • Woodbury Minnesota 55125 United States
    • University of Mississippi Medical Center
    • Jackson Mississippi 39216 United States
    • Saint Francis Medical Center
    • Cape Girardeau Missouri 63703 United States
    • Southeast Cancer Center
    • Cape Girardeau Missouri 63703 United States
    • University of Missouri - Ellis Fischel
    • Columbia Missouri 65212 United States
    • Barnes-Jewish West County Hospital
    • Creve Coeur Missouri 63141 United States
    • Mercy Hospital-Joplin
    • Joplin Missouri 64804 United States
    • Truman Medical Center
    • Kansas City Missouri 64108 United States
    • Saint Luke's Hospital of Kansas City
    • Kansas City Missouri 64111 United States
    • Kansas City Veterans Affairs Medical Center
    • Kansas City Missouri 64128 United States
    • The University of Kansas Cancer Center-South
    • Kansas City Missouri 64131 United States
    • Research Medical Center
    • Kansas City Missouri 64132 United States
    • The University of Kansas Cancer Center-North
    • Kansas City Missouri 64154 United States
    • The University of Kansas Cancer Center-Lee's Summit
    • Lee's Summit Missouri 64064 United States
    • Delbert Day Cancer Institute at PCRMC
    • Rolla Missouri 65401 United States
    • Heartland Regional Medical Center
    • Saint Joseph Missouri 64506 United States
    • Saint Louis Cancer and Breast Institute-South City
    • Saint Louis Missouri 63109 United States
    • Washington University School of Medicine
    • Saint Louis Missouri 63110 United States
    • Missouri Baptist Medical Center
    • Saint Louis Missouri 63131 United States
    • Mercy Hospital Saint Louis
    • Saint Louis Missouri 63141 United States
    • Siteman Cancer Center - Saint Peters
    • Saint Peters Missouri 63376 United States
    • Mercy Hospital Springfield
    • Springfield Missouri 65804 United States
    • CoxHealth South Hospital
    • Springfield Missouri 65807 United States
    • Billings Clinic Cancer Center
    • Billings Montana 59101 United States
    • Saint Vincent Healthcare
    • Billings Montana 59101 United States
    • Montana Cancer Consortium NCORP
    • Billings Montana 59102 United States
    • Bozeman Deaconess Hospital
    • Bozeman Montana 59715 United States
    • Benefis Healthcare- Sletten Cancer Institute
    • Great Falls Montana 59405 United States
    • CHI Health Saint Francis
    • Grand Island Nebraska 68803 United States
    • CHI Health Good Samaritan
    • Kearney Nebraska 68847 United States
    • Nebraska Methodist Hospital
    • Omaha Nebraska 68114 United States
    • Alegent Health Immanuel Medical Center
    • Omaha Nebraska 68122 United States
    • Alegent Health Bergan Mercy Medical Center
    • Omaha Nebraska 68124 United States
    • Alegent Health Lakeside Hospital
    • Omaha Nebraska 68130 United States
    • Creighton University Medical Center
    • Omaha Nebraska 68131 United States
    • Nevada Cancer Research Foundation CCOP
    • Las Vegas Nevada 89106 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89148 United States
    • Comprehensive Cancer Centers of Nevada - Central Valley
    • Las Vegas Nevada 89169 United States
    • Renown Regional Medical Center
    • Reno Nevada 89502 United States
    • New Hampshire Oncology Hematology PA-Concord
    • Concord New Hampshire 03301 United States
    • New Hampshire Oncology Hematology PA-Hooksett
    • Hooksett New Hampshire 03106 United States
    • LRGHealthcare-Lakes Region General Hospital
    • Laconia New Hampshire 03246 United States
    • Veterans Adminstration New Jersey Health Care System
    • East Orange New Jersey 07018-1095 United States
    • Rutgers Cancer Institute of New Jersey
    • New Brunswick New Jersey 08903 United States
    • Sparta Cancer Treatment Center
    • Sparta New Jersey 07871 United States
    • Lovelace Medical Center-Downtown
    • Albuquerque New Mexico 87102 United States
    • University of New Mexico Cancer Center
    • Albuquerque New Mexico 87102 United States
    • Hematology Oncology Associates
    • Albuquerque New Mexico 87106 United States
    • Memorial Medical Center - Las Cruces
    • Las Cruces New Mexico 88011 United States
    • Christus Saint Vincent Regional Cancer Center
    • Santa Fe New Mexico 87505 United States
    • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
    • Brooklyn New York 11209 United States
    • Veterans Affairs Western New York Health Care System-Buffalo
    • Buffalo New York 14215 United States
    • Roswell Park Cancer Institute
    • Buffalo New York 14263 United States
    • Hematology Oncology Associates of Central New York-East Syracuse
    • East Syracuse New York 13057 United States
    • Arnot Ogden Medical Center/Falck Cancer Center
    • Elmira New York 14905 United States
    • Glens Falls Hospital
    • Glens Falls New York 12801 United States
    • Orange Regional Medical Center
    • Middletown New York 10940 United States
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • New York New York 10016 United States
    • Columbia University/Herbert Irving Cancer Center
    • New York New York 10032 United States
    • Weill Medical College of Cornell University
    • New York New York 10065 United States
    • University of Rochester
    • Rochester New York 14642 United States
    • State University of New York Upstate Medical University
    • Syracuse New York 13210 United States
    • Montefiore Medical Center-Weiler Hospital
    • The Bronx New York 10461 United States
    • Montefiore Medical Center - Moses Campus
    • The Bronx New York 10467-2490 United States
    • Dickstein Cancer Treatment Center
    • White Plains New York 10601 United States
    • Mission Hospital-Memorial Campus
    • Asheville North Carolina 28801 United States
    • Carolinas Medical Center/Levine Cancer Institute
    • Charlotte North Carolina 28203 United States
    • Carolinas HealthCare System NorthEast
    • Concord North Carolina 28025 United States
    • Hendersonville Hematology and Oncology at Pardee
    • Hendersonville North Carolina 28791 United States
    • Margaret R Pardee Memorial Hospital
    • Hendersonville North Carolina 28791 United States
    • Park Ridge Hospital Breast Health Center
    • Hendersonville North Carolina 28792 United States
    • Kinston Medical Specialists PA
    • Kinston North Carolina 28501 United States
    • Carolinas HealthCare System Union
    • Monroe North Carolina 28112 United States
    • Carolinas HealthCare System Cleveland
    • Shelby North Carolina 28150 United States
    • Iredell Memorial Hospital
    • Statesville North Carolina 28677 United States
    • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • Winston-Salem North Carolina 27104 United States
    • Sanford Bismarck Medical Center
    • Bismarck North Dakota 58501 United States
    • Roger Maris Cancer Center
    • Fargo North Dakota 58122 United States
    • Sanford Clinic North-Fargo
    • Fargo North Dakota 58122 United States
    • Sanford Medical Center-Fargo
    • Fargo North Dakota 58122 United States
    • Summa Akron City Hospital/Cooper Cancer Center
    • Akron Ohio 44304 United States
    • Summa Barberton Hospital
    • Barberton Ohio 44203 United States
    • Adena Regional Medical Center
    • Chillicothe Ohio 45601 United States
    • The Christ Hospital
    • Cincinnati Ohio 45219 United States
    • University of Cincinnati/Barrett Cancer Center
    • Cincinnati Ohio 45219 United States
    • MetroHealth Medical Center
    • Cleveland Ohio 44109 United States
    • Ohio State University Comprehensive Cancer Center
    • Columbus Ohio 43210 United States
    • Columbus Oncology and Hematology Associates Inc
    • Columbus Ohio 43214 United States
    • Riverside Methodist Hospital
    • Columbus Ohio 43214 United States
    • Columbus NCI Community Oncology Research Program
    • Columbus Ohio 43215 United States
    • Grant Medical Center
    • Columbus Ohio 43215 United States
    • The Mark H Zangmeister Center
    • Columbus Ohio 43219 United States
    • Mount Carmel Health Center West
    • Columbus Ohio 43222 United States
    • Good Samaritan Hospital - Dayton
    • Dayton Ohio 45406 United States
    • Miami Valley Hospital
    • Dayton Ohio 45409 United States
    • Samaritan North Health Center
    • Dayton Ohio 45415 United States
    • Dayton NCI Community Oncology Research Program
    • Dayton Ohio 45420 United States
    • Veteran Affairs Medical Center
    • Dayton Ohio 45428 United States
    • Delaware Health Center-Grady Cancer Center
    • Delaware Ohio 43015 United States
    • Armes Family Cancer Center
    • Findlay Ohio 45840 United States
    • Orion Cancer Care
    • Findlay Ohio 45840 United States
    • Atrium Medical Center-Middletown Regional Hospital
    • Franklin Ohio 45005-1066 United States
    • Dayton Physicians LLC-Atrium
    • Franklin Ohio 45005 United States
    • Kettering Medical Center
    • Kettering Ohio 45429 United States
    • Saint Rita's Medical Center
    • Lima Ohio 45801 United States
    • Marietta Memorial Hospital
    • Marietta Ohio 45750 United States
    • Toledo Clinic Cancer Centers-Maumee
    • Maumee Ohio 43537 United States
    • Saint Charles Hospital
    • Oregon Ohio 43616 United States
    • Mercy Health Perrysburg Cancer Center
    • Perrysburg Ohio 43551 United States
    • Southern Ohio Medical Center
    • Portsmouth Ohio 45662 United States
    • Springfield Regional Medical Center
    • Springfield Ohio 45505 United States
    • Mercy Saint Anne Hospital
    • Toledo Ohio 43623 United States
    • Toledo Clinic Cancer Centers-Toledo
    • Toledo Ohio 43623 United States
    • Upper Valley Medical Center
    • Troy Ohio 45373 United States
    • Saint Ann's Hospital
    • Westerville Ohio 43081 United States
    • Wright-Patterson Medical Center
    • Wright-Patterson Air Force Base Ohio 45433-5529 United States
    • University of Oklahoma Health Sciences Center
    • Oklahoma City Oklahoma 73104 United States
    • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Tulsa Oklahoma 74146 United States
    • Legacy Mount Hood Medical Center
    • Gresham Oregon 97030 United States
    • Legacy Good Samaritan Hospital and Medical Center
    • Portland Oregon 97210 United States
    • Kaiser Permanente Northwest
    • Portland Oregon 97227 United States
    • Oregon Health and Science University
    • Portland Oregon 97239 United States
    • Portland Veterans Administration Medical Center
    • Portland Oregon 97239 United States
    • Legacy Meridian Park Hospital
    • Tualatin Oregon 97062 United States
    • Lehigh Valley Hospital-Cedar Crest
    • Allentown Pennsylvania 18103 United States
    • Lehigh Valley Hospital - Muhlenberg
    • Bethlehem Pennsylvania 18017 United States
    • Doylestown Hospital
    • Doylestown Pennsylvania 18901 United States
    • Penn State Milton S Hershey Medical Center
    • Hershey Pennsylvania 17033-0850 United States
    • Thomas Jefferson University Hospital
    • Philadelphia Pennsylvania 19107 United States
    • Fox Chase Cancer Center
    • Philadelphia Pennsylvania 19111 United States
    • Temple University Hospital
    • Philadelphia Pennsylvania 19140 United States
    • Hematology and Oncology Associates of North East Pennsylvania
    • Scranton Pennsylvania 18508 United States
    • Reading Hospital
    • West Reading Pennsylvania 19611 United States
    • Susquehanna Cancer Center
    • Williamsport Pennsylvania 17701 United States
    • AnMed Health Cancer Center
    • Anderson South Carolina 29621 United States
    • Roper Hospital
    • Charleston South Carolina 29401 United States
    • Charleston Hematology Oncology Associates-Roper
    • Charleston South Carolina 29403 United States
    • Charleston Hematology Oncology Associates PA-St. Francis
    • Charleston South Carolina 29414 United States
    • Medical University of South Carolina
    • Charleston South Carolina 29425 United States
    • Greenville Health System Cancer Institute-Easley
    • Easley South Carolina 29640 United States
    • McLeod Regional Medical Center
    • Florence South Carolina 29506 United States
    • Saint Francis Hospital
    • Greenville South Carolina 29601 United States
    • Greenville Health System Cancer Institute-Butternut
    • Greenville South Carolina 29605 United States
    • Greenville Health System Cancer Institute-Faris
    • Greenville South Carolina 29605 United States
    • Greenville Memorial Hospital
    • Greenville South Carolina 29605 United States
    • Saint Francis Cancer Center
    • Greenville South Carolina 29607 United States
    • Greenville Health System Cancer Institute-Eastside
    • Greenville South Carolina 29615 United States
    • Self Regional Healthcare
    • Greenwood South Carolina 29646 United States
    • Greenville Health System Cancer Institute-Greer
    • Greer South Carolina 29650 United States
    • Greenville Health System Cancer Institute-Seneca
    • Seneca South Carolina 29672 United States
    • Spartanburg Medical Center
    • Spartanburg South Carolina 29303 United States
    • Greenville Health System Cancer Institute-Spartanburg
    • Spartanburg South Carolina 29307 United States
    • Sanford Cancer Center-Oncology Clinic
    • Sioux Falls South Dakota 57104 United States
    • Sanford USD Medical Center - Sioux Falls
    • Sioux Falls South Dakota 57117-5134 United States
    • Erlanger Medical Center
    • Chattanooga Tennessee 37403 United States
    • University of Tennessee - Knoxville
    • Knoxville Tennessee 37920 United States
    • Meharry Medical College
    • Nashville Tennessee 37208 United States
    • UT Southwestern/Simmons Cancer Center-Dallas
    • Dallas Texas 75390 United States
    • Lyndon Baines Johnson General Hospital
    • Houston Texas 77026-1967 United States
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Houston Texas 77030 United States
    • Ben Taub General Hospital
    • Houston Texas 77030 United States
    • M D Anderson Cancer Center
    • Houston Texas 77030 United States
    • Michael E DeBakey VA Medical Center
    • Houston Texas 77030 United States
    • MD Anderson Regional Care Center-Katy
    • Houston Texas 77094 United States
    • MD Anderson Regional Care Center-Bay Area
    • Nassau Bay Texas 77058 United States
    • MD Anderson Regional Care Center-Sugar Land
    • Sugar Land Texas 77478 United States
    • MD Anderson Regional Care Center-The Woodlands
    • The Woodlands Texas 77384 United States
    • Huntsman Cancer Institute/University of Utah
    • Salt Lake City Utah 84112 United States
    • Inova Fairfax Hospital
    • Falls Church Virginia 22042 United States
    • Lynchburg Hematology-Oncology Clinic
    • Lynchburg Virginia 24501 United States
    • Memorial Hospital Of Martinsville
    • Martinsville Virginia 24115 United States
    • Virginia Commonwealth University/Massey Cancer Center
    • Richmond Virginia 23298 United States
    • VCU Community Memorial Health Center
    • South Hill Virginia 23970 United States
    • Shenandoah Oncology Associates PC
    • Winchester Virginia 22601 United States
    • MultiCare Auburn Medical Center
    • Auburn Washington 98001 United States
    • PeaceHealth Saint Joseph Medical Center
    • Bellingham Washington 98225 United States
    • Highline Medical Center-Main Campus
    • Burien Washington 98166 United States
    • Providence Regional Cancer Partnership
    • Everett Washington 98201 United States
    • MultiCare Gig Harbor Medical Park
    • Gig Harbor Washington 98335 United States
    • Kadlec Clinic Hematology and Oncology
    • Kennewick Washington 99336 United States
    • Seattle Cancer Care Alliance at EvergreenHealth
    • Kirkland Washington 98034 United States
    • Skagit Valley Hospital
    • Mount Vernon Washington 98274 United States
    • Jefferson Healthcare
    • Port Townsend Washington 98368 United States
    • MultiCare Good Samaritan Hospital
    • Puyallup Washington 98372 United States
    • Minor and James Medical PLLC
    • Seattle Washington 98104 United States
    • Fred Hutchinson Cancer Research Center
    • Seattle Washington 98109 United States
    • Group Health Cooperative-Seattle
    • Seattle Washington 98112 United States
    • Swedish Medical Center-First Hill
    • Seattle Washington 98122-4307 United States
    • University of Washington Medical Center
    • Seattle Washington 98195 United States
    • Rockwood Clinic Cancer Treatment Center-Valley
    • Spokane Valley Washington 99216 United States
    • Rockwood Cancer Treatment Center-DHEC-Downtown
    • Spokane Washington 99204 United States
    • Rockwood Clinic
    • Spokane Washington 99220 United States
    • MultiCare Tacoma General Hospital
    • Tacoma Washington 98405 United States
    • Northwest NCI Community Oncology Research Program
    • Tacoma Washington 98405 United States
    • Madigan Army Medical Center
    • Tacoma Washington 98431 United States
    • Legacy Salmon Creek Hospital
    • Vancouver Washington 98686 United States
    • Providence Saint Mary Regional Cancer Center
    • Walla Walla Washington 99362 United States
    • West Virginia University Charleston
    • Charleston West Virginia 25304 United States
    • Edwards Comprehensive Cancer Center
    • Huntington West Virginia 25701 United States
    • Langlade Hospital and Cancer Center
    • Antigo Wisconsin 54409 United States
    • Aurora Cancer Care-Southern Lakes VLCC
    • Burlington Wisconsin 53105 United States
    • Marshfield Clinic-Chippewa Center
    • Chippewa Falls Wisconsin 54729 United States
    • Marshfield Clinic Cancer Center at Sacred Heart
    • Eau Claire Wisconsin 54701 United States
    • Sacred Heart Hospital
    • Eau Claire Wisconsin 54701 United States
    • Aurora Health Center-Fond du Lac
    • Fond du Lac Wisconsin 54937 United States
    • Aurora Health Care Germantown Health Center
    • Germantown Wisconsin 53022 United States
    • Aurora Cancer Care-Grafton
    • Grafton Wisconsin 53024 United States
    • Green Bay Oncology at Saint Vincent Hospital
    • Green Bay Wisconsin 54301-3526 United States
    • Saint Vincent Hospital Cancer Center Green Bay
    • Green Bay Wisconsin 54301 United States
    • Green Bay Oncology Limited at Saint Mary's Hospital
    • Green Bay Wisconsin 54303 United States
    • Saint Vincent Hospital Cancer Center at Saint Mary's
    • Green Bay Wisconsin 54303 United States
    • Aurora BayCare Medical Center
    • Green Bay Wisconsin 54311 United States
    • Mercy Health System
    • Janesville Wisconsin 53547 United States
    • UW Cancer Center Johnson Creek
    • Johnson Creek Wisconsin 53038 United States
    • Aurora Cancer Care-Kenosha South
    • Kenosha Wisconsin 53142 United States
    • Gundersen Lutheran Medical Center
    • La Crosse Wisconsin 54601 United States
    • Marshfield Clinic - Ladysmith Center
    • Ladysmith Wisconsin 54848 United States
    • University of Wisconsin Hospital and Clinics
    • Madison Wisconsin 53792 United States
    • Holy Family Memorial Hospital
    • Manitowoc Wisconsin 54221 United States
    • Aurora Bay Area Medical Group-Marinette
    • Marinette Wisconsin 54143 United States
    • Vince Lombardi Cancer Clinic-Marinette
    • Marinette Wisconsin 54143 United States
    • Marshfield Clinic
    • Marshfield Wisconsin 54449 United States
    • Saint Joseph's Hospital
    • Marshfield Wisconsin 54449 United States
    • Aurora Cancer Care-Milwaukee
    • Milwaukee Wisconsin 53209 United States
    • Aurora Saint Luke's Medical Center
    • Milwaukee Wisconsin 53215 United States
    • Froedtert and the Medical College of Wisconsin
    • Milwaukee Wisconsin 53226 United States
    • Aurora Sinai Medical Center
    • Milwaukee Wisconsin 53233 United States
    • Marshfield Clinic-Minocqua Center
    • Minocqua Wisconsin 54548 United States
    • Cancer Center of Western Wisconsin
    • New Richmond Wisconsin 54017 United States
    • Green Bay Oncology - Oconto Falls
    • Oconto Falls Wisconsin 54154 United States
    • Vince Lombardi Cancer Clinic - Oshkosh
    • Oshkosh Wisconsin 54904 United States
    • Aurora Cancer Care-Racine
    • Racine Wisconsin 53406 United States
    • Marshfield Clinic at James Beck Cancer Center
    • Rhinelander Wisconsin 54501 United States
    • Saint Mary's Hospital
    • Rhinelander Wisconsin 54501 United States
    • Marshfield Clinic-Rice Lake Center
    • Rice Lake Wisconsin 54868 United States
    • HSHS Saint Nicholas Hospital
    • Sheboygan Wisconsin 53081 United States
    • Vince Lombardi Cancer Clinic-Sheboygan
    • Sheboygan Wisconsin 53081 United States
    • Marshfield Clinic Cancer Care at Saint Michael's Hospital
    • Stevens Point Wisconsin 54481 United States
    • Saint Michael's Hospital
    • Stevens Point Wisconsin 54481 United States
    • Marshfield Clinic Stevens Point Center
    • Stevens Point Wisconsin 54482 United States
    • Saint Vincent Hospital Cancer Center at Sturgeon Bay
    • Sturgeon Bay Wisconsin 54235-1495 United States
    • Green Bay Oncology - Sturgeon Bay
    • Sturgeon Bay Wisconsin 54235 United States
    • Aurora Medical Center in Summit
    • Summit Wisconsin 53066 United States
    • Vince Lombardi Cancer Clinic-Two Rivers
    • Two Rivers Wisconsin 54241 United States
    • Aurora Cancer Care-Waukesha
    • Waukesha Wisconsin 53188 United States
    • Aspirus Regional Cancer Center
    • Wausau Wisconsin 54401 United States
    • Marshfield Clinic-Wausau Center
    • Wausau Wisconsin 54401 United States
    • Aurora Cancer Care-Milwaukee West
    • Wauwatosa Wisconsin 53226 United States
    • Aurora West Allis Medical Center
    • West Allis Wisconsin 53227 United States
    • Diagnostic and Treatment Center
    • Weston Wisconsin 54476 United States
    • Marshfield Clinic - Weston Center
    • Weston Wisconsin 54476 United States
    • Aspirus UW Cancer Center
    • Wisconsin Rapids Wisconsin 54494 United States
    • Marshfield Clinic - Wisconsin Rapids Center
    • Wisconsin Rapids Wisconsin 54494 United States
    • Billings Clinic-Cody
    • Cody Wyoming 82414 United States

    View trial on ClinicalTrials.gov


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    Published July 12, 2017
  • A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma

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    A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma


    Condition: Prostate Adenocarcinoma

    Intervention:

    • Diagnostic Test: F-18 fluciclovine-PET/CT scan

    Purpose: Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03496844

    Sponsor: University of Arizona

    Primary Outcome Measures:

    • Measure: True positive and false positive rate of positive bone findings on F-18 fluciclovine-PET/CT scan compared to gold standard of bone biopsy
    • Time Frame: 3 years
    • Safety Issue:

    Estimated Enrollment: 20

    Study Start Date: April 15, 2018

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Male
    2. Be ≥ 18 years of age
    3. Diagnosed with prostate cancer
    4. Be willing and able to provide informed consent
    5. Be informed of the investigational nature of this study

    Exclusion Criteria:

    1. Having a history of severe claustrophobia
    2. Weight exceeding 400lbs

    Contact:

    • Carol Stuehm
    • 5206268318

    Location:

    • University of Arizona
    • Tucson Arizona 85724 United States

    View trial on ClinicalTrials.gov


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    Published March 13, 2019
  • A Pilot Trial of Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

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    A Pilot Trial of Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer


    Condition: Metastatic Hormone-Sensitive Prostate Cancer

    Intervention:

    • Biological: PROSTVAC-V
    • Biological: PROSTVAC-F
    • Drug: Nivolumab
    • Drug: Ipilimumab
    • Biological: Neoantigen DNA vaccine
    • Device: TriGrid Delivery System
    • Procedure: Tumor biopsy
    • Procedure: Peripheral blood
    • Procedure: Fecal samples
    • Procedure: Leukapheresis

    Purpose: This study study aims to elucidate the immune responses to a shared antigen vaccine (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the investigators will study the impact of the combination immunotherapy on peripheral T cell activation, as well as immune response in the tumor microenvironment. Finally, the investigators will evaluate the safety and tolerability to this novel personalized immunotherapy in combination with checkpoint blockade.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03532217

    Sponsor: Washington University School of Medicine

    Primary Outcome Measures:

    • Measure: Safety and tolerability of regimen as defined by incidence of adverse events
    • Time Frame: Through 100 days after completion of treatment (estimated to be 55 weeks)
    • Safety Issue:
    • Measure: Immune response as measured by tetramers
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Immune response as measured by genomic studies
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Immune response as measured by flow cytometry
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Safety and tolerability of regimen as defined by incidence of dose-limiting toxicities (DLTs)
    • Time Frame: Through 100 days after completion of treatment (estimated to be 55 weeks)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Failure-free survival (FFS)
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Milestone survival
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: Number of participants who have PSA responses at 30% reduction level
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Number of participants who have PSA responses at 50% reduction level
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Radiographic progression as determined by RECIST 1.1
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3)
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Radiographic progression free survival (rPFS)
    • Time Frame: Through completion of treatment (estimated to be 41 weeks)
    • Safety Issue:
    • Measure: Comparison of the immune correlates on matched tumor tissue and peripheral blood
    • Time Frame: Pre- and post-treatment (estimated to be 41 weeks)
    • Safety Issue:

    Estimated Enrollment: 20

    Study Start Date: September 14, 2018

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate.
    • High risk/volume metastatic disease, as defined by 4 or more sites of disease or the presence of visceral metastases.
    • Must have completed an adequate course of chemo-hormonal, first line therapy for metastatic hormone-sensitive prostate cancer, as determined by the investigator. Patients must remain on stable dose of ADT with castrate levels of testosterone (defined as testosterone < 50 ng/dL)
    • At least 18 years of age.
    • PSA may be undetectable after initial chemo-ADT.
    • ECOG performance status ≤ 2
    • Normal bone marrow and organ function as defined below:
    • Leukocytes ≥ 2,000/ul
    • Absolute neutrophil count ≥ 1,500/ul
    • Platelets ≥ 100,000/ul
    • Hemoglobin ≥ 9.0 g/ul
    • Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert's syndrome who must have a total bilirubin level of ≤ 3.0 ULN)
    • AST(SGOT) ≤ 3.0 x ULN
    • ALT(SGPT) ≤ 3.0 x ULN
    • Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault formula
    • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
    • Must have a biopsy of a metastatic site of disease (may be archival) available and adequate for evaluation and determination of neoantigens by genomic analyses.
    • Must have all AEs resolved to baseline prior to chemo-ADT, or if treatment related, resolved to grade 1 prior to enrollment.

    Exclusion Criteria:

    • Significant small cell or neuroendocrine component or histology, as determined by the institution's reading pathologist.
    • Progression of disease as defined by a rising PSA (3 sequential values, at least 1 week apart) or radiographic progression based on RECIST1.1 or PCWG3 criteria.
    • Prior treatment with a checkpoint inhibitor, neoantigen vaccine, or PROSTVAC.
    • Participants with active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
    • Diagnosis of atopic dermatitis or other active exfoliative skin condition
    • Prior malignancy active within the previous 3 years with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, superficial bladder cancer or carcinoma in situ of cervix or breast.
    • Currently receiving any other investigational agents.
    • Known brain metastases. Prostate cancer patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis, and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-PD-1, anti-CTLA-4, Prostvac-VF Tricom, DNA vaccines, or other agents used in the study.
    • Prior allergy or significant systemic reaction to vaccinia.
    • Prior reactions to monoclonal antibodies.
    • Received hematopoietic stem cell transplant < 24 months prior to enrollment to this study, or received hematopoietic stem cell transplant ≥ 24 months prior to enrollment to this study but has graft-versus-host disease or disease relapse.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant congestive heart failure (NYHA Class III, IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements.
    • Immunosuppressed status (e.g. HIV/AIDS, active HCV/HBV, high dose systemic steroids, etc.) as determined by the investigator; topical or inhaled steroids are acceptable.
    • History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.
    • Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.
    • Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
    • Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
    • Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
    • Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.

    Contact:

    • Russell Pachynski, M.D.
    • 314-286-2341

    Locations:

    • National Cancer Institute (GU Malignancies Branch)
    • Bethesda Maryland 20892 United States
    • Washington University School of Medicine
    • Saint Louis Missouri 63110 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • A Prospective Randomised Phase III Study of Androgen Deprivation Therapy (+/- Docetaxel) With or Without Local Radiotherapy With or Without Abiraterone Acetate and Prednisone in Patient With Metastatic Hormone-naïve Prostate Cancer.

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    A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer


    Condition: Metastatic Prostate Cancer

    Intervention:

    • Drug: abiraterone acetate
    • Radiation: radiotherapy
    • Other: Androgen Deprivation Therapy
    • Drug: Docetaxel

    Purpose: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy (+ docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01957436

    Sponsor: UNICANCER

    Primary Outcome Measures:

    • Measure: Survival
    • Time Frame: 5.5 years after the first inclusion
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: PSA response rate
    • Time Frame: 8 months
    • Safety Issue:
    • Measure: Prospective correlative study of PSA response/progression
    • Time Frame: 8 months
    • Safety Issue:
    • Measure: Prostate cancer specific survival
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Time to next skeletal-related event
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Time to chemotherapy
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Time to severe local symptoms
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Toxicity of the study treatment
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: The radiological progression-free survival
    • Time Frame: 5.5 years
    • Safety Issue:
    • Measure: Impact of radiotherapy protocol on outcome
    • Time Frame: 5.5 years
    • Safety Issue:

    Estimated Enrollment: 1168

    Study Start Date: November 13, 2013

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Histologically or cytologically confirmed adenocarcinoma of the prostate, 2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes can be included if they have either:
    • At least one extra-pelvic lymph node ≥ 2 cm or
    • extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm 3. Patients with ECOG ≤ 1 (PS 2 due to bone pain accepted), 4. Life expectancy ≥ 6 months, 5. Male aged ≥ 18 years old, 6. Hemoglobin ≥ 10.0 g/dL, 7. Platelet count ≥ 100,000/μL, 8. Serum creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min, 9. Serum potassium ≥ 4.0 mmol/L, 10. Serum bilirubin ≤ 1.5 x ULN (except documented Gilbert's disease); AST and ALT ≤ 1.5 x ULN (≤ 5 ULN in case of liver metastases), ALP ≤ 2.5 x ULN 11. Patients might have received a maximum of 3 months of ADT before randomization, 12. Patients might have received previous radiation therapy directed to bone lesions 13. Patients able to take oral medication, 14. Patients who have received the information sheet and signed the informed consent form, 15. Male patients who are receiving the study treatment and have partners of childbearing potential are advised to use a method of birth control with adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment. 16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, 17. Patients with a public or a private health insurance coverage, 18. Patients willing to receive docetaxel 19. Neutrophil ≥ 1500 cells/mm3 20. Male patients who have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of docetaxel.

    Exclusion Criteria:

    1. Patients with previous local treatment directed to the prostate primary cancer. A previous TURP is allowed,
    2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
    3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
    4. Active infection or other medical condition for which corticosteroid use would be contraindicated,
    5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
    6. Prior systemic treatment with an azole drug within 4 weeks of randomization,
    7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
    8. Patients with a history of hypertension except if blood pressure is controlled by anti-hypertensive treatment,
    9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
    10. History of pituitary or adrenal dysfunction,
    11. Small cell carcinoma of the prostate,
    12. Clinically known significant heart disease (myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac EF < 50% at baseline,
    13. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
    14. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
    15. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
    16. Administration of an investigational therapeutic within 30 days of D1,
    17. Patients already included in another therapeutic trial involving an experimental drug,
    18. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering participation,
    19. Individual deprived of liberty or placed under the authority of a tutor. Additional criteria for patients receiving docetaxel:
    20. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.
    21. Concomitant use of strong CYP3A4 inhibitors ( clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)
    22. Allergy to taxane

    Contact:

    • Beata JUZYNA

    Locations:

    • Onze Lieve Vrouw Ziekenhuis
    • Aalst Belgium
    • Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet
    • Brussels Belgium
    • Hopital de Jolimont
    • Haine Saint Paul Belgium
    • AZ Groeninge Kortrijk - Campus Vercruysselaan
    • Kortrijk Belgium
    • Cliniques Universitaires Saint Luc
    • Louvain Belgium
    • Cliniques Universitaires Saint-Luc
    • Louvain Belgium
    • Centre Radiotherapie Oncologie Moyenne Garonne-CROMG
    • Agen France
    • Clinique Claude Bernard
    • Albi 81000 France
    • Clinique de L'Europe
    • Amiens France
    • Institut de cancerologie de l'Ouest
    • ANGERS Cedex 9 49933 France
    • Clinique Générale d'Annecy
    • Annecy 74000 France
    • Centre Marie Curie
    • Arras France
    • Institut Sainte Catherine
    • Avignon Cedex 9 84918 France
    • Centre de la Baie
    • Avranches France
    • Centre d'Oncologie et de Radiothérapie du Pays Basque
    • Bayonne 64100 France
    • Chu Jean Minjoz
    • Besancon 25030 France
    • Centre Pierre Curie
    • Beuvry France
    • Institut Bergonie
    • Bordeaux 33076 France
    • Clinique Pasteur
    • Brest 29200 France
    • Centre François Baclesse
    • Caen France
    • Centre Hospitalier Alpes Leman
    • Contamine Sur Arve 74130 France
    • SERA
    • Contamine Sur Arve 74130 France
    • Chu de Mondor
    • Creteil 94010 France
    • Centre Leonard de Vinci
    • Dechy France
    • Centre Georges-François LECLERC
    • Dijon 21079 France
    • Clinique Sainte Marguerite
    • Hyères 83400 France
    • CHD Vendée
    • La ROCHE sur YON 85925 France
    • Clinique Victor Hugo
    • Le Mans 72000 France
    • Chu de Limoges
    • Limoges 87042 France
    • Centre Léon Bérard
    • Lyon cedex 08 69373 France
    • CHU Lyon Sud
    • Lyon France
    • Chu Timone
    • MARSEILLE Cedex 5 13385 France
    • Institut Paoli Calmettes
    • Marseille 13273 France
    • Hôpital Nord
    • Marseille France
    • Groupe Hospitalier Intercommunal Le Raincy Montfermeil
    • Montfermeil France
    • Centre Azuréen de Cancérologie
    • Mougins 06250 France
    • Centre de Radiothérapie de Macon
    • Mâcon France
    • Centre Catherine de Sienne
    • Nantes Cedex 2 44202 France
    • Centre Antoine Lacassagne
    • Nice 06189 France
    • CHU Carémeau
    • NIMES Cedex 9 30029 France
    • CHR Orléans la source
    • Orleans 45100 France
    • Institut Curie
    • Paris 75005 France
    • Hôpital St Louis
    • Paris 75010 France
    • Hopital TENON
    • Paris France
    • Chic Quimper
    • Quimper 29107 France
    • Centre Eugène Marquis
    • RENNES Cedex 35042 France
    • Centre de Radiothérapie CROM et d'Oncologie Medical de L'Essonne
    • Ris-Orangis France
    • Chu de Rouen
    • Rouen 76031 France
    • Clinique Armoricaine de radiologie
    • Saint Brieuc 22015 France
    • CHU ST ETIENNE - Hôpital Nord
    • Saint Etienne 44270 France
    • CHP Saint Grégoire
    • Saint Gregoire 35760 France
    • Institut de Cancérologie del'Ouest - site René Gauducheau
    • Saint-herblain 44805 France
    • CENTRE DE CANCEROLOGIE Paris Nord
    • Sarcelles France
    • Institut de Cancérologie Lucien Neuwirth
    • St PRIEST EN JAREZ 42271 France
    • Strasbourg Oncologie Libérale
    • Strasbourg 67000 France
    • Hopitaux du Leman
    • Thonon-les-bains 74203 France
    • Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse
    • Toulon 83056 France
    • Clinique Pasteur
    • TOULOUSE Cedex 3 31076 France
    • Institut Claudius Regaud
    • TOULOUSE Cedex 31052 France
    • CHU de TOURS Hôpital Bretonneau
    • Tours France
    • Centre d'Oncologie Saint Yves
    • Vannes France
    • INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris
    • Villejuif 94805 France
    • Universitäts-klinikum Freiburg
    • Freiburg Germany
    • Gesundheitszentrum Holzminden
    • Holzminden Germany
    • Cork University Hospital
    • Cork Ireland
    • Adelaide and Meath incorporating National Children's hospital department
    • Dublin Ireland
    • Mater Misericordiae University Hospital
    • Dublin Ireland
    • Mater Private Hospital
    • Dublin Ireland
    • St Vincent's University Hospital
    • Dublin Ireland
    • Galway University Hospital
    • Galway Ireland
    • Università di Brescia - Sistema Socio Sanitaria Territoriale, ASST Spedali civili Brescia
    • Brescia Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Meldola Italy
    • San Camillo Forlanini Hospitals
    • Roma Italy
    • 'Hospital Bestriz angelo
    • Loures Portugal
    • 'Instituto Portugues de Oncologia do Porto Francisco Gentil, E,P,E
    • Porto Portugal
    • Sc Radiotherapy Center Cluj SRL
    • Cluj Romania
    • Hospital Germans Trias i Pujol
    • Badalona Spain
    • Hospital De la Santa Creu I Sant Pau
    • Barcelona Spain
    • Hospital del Mar
    • Barcelona Spain
    • Vall d'Hebron University Hospital
    • Barcelona Spain
    • ICO Girona - Hospital Josep Trueta
    • Girona Spain
    • Hospital Universitario Lucus Augusti
    • Lugo Spain
    • Hospital 12 OCTUBRE
    • Madrid Spain
    • Hospital Universitario HM Sanchinarro
    • Madrid Spain
    • Althaia
    • Manresa Spain
    • 'Hospital Clinico Virgen de la Victoria
    • Málaga Spain
    • 'Parc Tauli Sabadell Hospital Universitari
    • Sabadell Spain
    • Hospital Universitario de Salamanca
    • Salamanca Spain
    • Institut Valenciano de Oncologia
    • Valencia Spain
    • Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti
    • Geneva Switzerland
    • Centre Hospitalier Universitaire Vaudois
    • Lausanne Switzerland

    View trial on ClinicalTrials.gov


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    Published September 9, 2017
  • A Randomized Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Hormone-Sensitive Prostate Cancer

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    A Randomized Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Hormone-Sensitive Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: Ibrance
    • Drug: Bicalutamide
    • Drug: Zoladex
    • Drug: Lupron Depot

    Purpose: This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer. The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02059213

    Sponsor: University of Michigan Cancer Center

    Primary Outcome Measures:

    • Measure: Number of patients who achieve a PSA ≤ 4ng/mL after seven months of protocol treatment in each arm
    • Time Frame: 28 weeks
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Frequency of adverse events
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Duration of therapy
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Proportion of patients who achieve undetectable PSA (<0.2ng/mL)
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Time to biochemical progression
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Time to clinical progression
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Frequency of dose modification
    • Time Frame: Up to 54 months
    • Safety Issue:
    • Measure: Frequency of treatment delay
    • Time Frame: Up to 54 months
    • Safety Issue:

    Estimated Enrollment: 60

    Study Start Date: June 2014

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Have pathologic diagnosis of prostate cancer.
    • Have hormone-sensitive metastatic disease (M1) as evidenced by soft tissue and/or bony metastases.
    • Patients may either be untreated for their newly diagnosed metastatic disease (preferred as much as possible) or have started androgen deprivation therapy. Patients who have started androgen deprivation therapy for the treatment of their newly diagnosed metastatic disease are eligible as long as the duration of treatment is less than or equal to 2 weeks (14days) prior to registration. The start date of androgen deprivation is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not the date when an oral antiandrogen started.
    • Patients must have a minimum PSA (Prostate-Specific Antigen) ≥ 5 ng/mL within 60 days of registration or prior to the initiation of androgen deprivation for patients who have started androgen deprivation therapy.
    • Agree to undergo a biopsy of at least one metastatic site for RB (Retinoblastoma Protein) status evaluation. Adequate metastatic tissue from prior biopsy/resection can be used if available in lieu of a biopsy.
    • ECOG performance status of 0-2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death).
    • Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy, for non-metastatic disease but it must not have lasted for more than 36 months. At least 12 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting.
    • Within 14 days prior to registration patients must have adequate organ and marrow function: White Blood Cell (WBC) count ≥ 3,000/μl, Absolute Neutrophil Count (ANC) ≥ 1,500/μl, Platelet Count ≥ 100,000/μl, Serum Creatinine ≥1.5 x the institutional upper limits of normal or corrected creatinine clearance of ≥ 50 mg/ml/hr/1.73 m2 BSA (Body Surface Area), Bilirubin within the institutional limits of normal, AST (Aspartate Aminotransferase) ≤ 2 x upper limits of normal, ALT (Alanine Aminotransferase) ≤ 2 x upper limits of normal.
    • Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
    • Patients may have received prior radiation therapy or surgery. However, at least 14 days must have elapsed since completion of radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration.
    • Patients must agree to use highly effective contraception during treatment and for a period of 90 days after ending treatment with PD 0332991.
    • Ability to understand and the willingness to sign a written informed consent document that is approved by an institutional review board.

    Exclusion Criteria:

    • Patients who have received androgen deprivation therapy for greater than 14 days (LHRH-agonist or antagonist) for the treatment of their newly diagnosed metastatic disease prior to enrollment are not eligible for this study.
    • Patients who are currently being treated with strong CYP3A4 inhibitors (e.g., amprenavir, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit) or strong inducers (e.g., carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine and St. John's wort) must either discontinue these drugs or are ineligible.
    • Patients must refrain from the use of proton pump inhibitors. If needed, alternative antacid therapies may be used including H2-receptor antagonists, and locally acting antacids.
    • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a "currently active" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year.
    • HIV-positive patients on combination antiretroviral therapy are ineligible .

    Contact:

    • Maha Hussain, MD, FACP, FASCO
    • 312-695-6180

    Locations:

    • City of Hope Cancer Center
    • Duarte California 91010 United States
    • Northwestern University
    • Chicago Illinois 60611 United States
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore Maryland 21231 United States
    • University of Michigan Hospital
    • Ann Arbor Michigan 48109 United States
    • Washington University in St. Louis
    • St. Louis Missouri 63110 United States
    • Thomas Jefferson University
    • Philadelphia Pennsylvania 19107 United States
    • Vanderbilt-Ingram Cancer Center
    • Nashville Tennessee 37232 United States
    • Huntsman Cancer Institute, University of Utah
    • Salt Lake City Utah 84112 United States

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

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    A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer


    Condition: Prostatic Neoplasms

    Intervention:

    • Drug: BAY1841788 / darolutamide (ODM-201)
    • Drug: Standard ADT (androgen deprivation therapy)
    • Drug: Docetaxel
    • Drug: Placebo

    Purpose: The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02799602

    Sponsor: Bayer

    Primary Outcome Measures:

    • Measure: Overall survival
    • Time Frame: approximately 70 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Time to castration resistant prostate cancer
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Time to initiation of subsequent antineoplastic therapy
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Symptomatic skeletal event free survival (SSE-FS)
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Time to first symptomatic skeletal event (SSE)
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Time to initiation of opioid use
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Time to worsening of physical symptoms of disease
    • Time Frame: approximately 70 months
    • Safety Issue:
    • Measure: Number of participants with adverse events as a measure of safety and tolerability
    • Time Frame: approximately 70 months
    • Safety Issue:

    Estimated Enrollment: 1300

    Study Start Date: November 30, 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of prostate.
    • Metastatic disease
    • Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
    • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Adequate bone marrow, liver and renal function

    Exclusion Criteria:

    • Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201); other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.
    • Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
    • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
    • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
    • Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
    • Inability to swallow oral medications

    Contact:

    • Bayer Clinical Trials Contact
    • (+)1-888-84 22937

    Locations:

    • Chandler Arizona 85224 United States
    • Gilbert Arizona 85234 United States
    • Scottsdale Arizona 85259-5452 United States
    • Tucson Arizona 85724 United States
    • Beverly Hills California 90211-1850 United States
    • Duarte California 91010 United States
    • Los Angeles California 90073-1003 United States
    • Stanford California 94305-5820 United States
    • Aurora Colorado 80045 United States
    • Denver Colorado 80211 United States
    • Englewood Colorado 80113-2766 United States
    • New Haven Connecticut 06520 United States
    • Washington District of Columbia 20007-2197 United States
    • Boca Raton Florida 33486 United States
    • Gainesville Florida 32608 United States
    • Miami Beach Florida 33140 United States
    • Tampa Florida 33612 United States
    • Atlanta Georgia 30322 United States
    • Newnan Georgia 30265 United States
    • Chicago Illinois 60611 United States
    • Peoria Illinois 61615-7828 United States
    • Louisville Kentucky 40202 United States
    • New Orleans Louisiana 70112 United States
    • Baltimore Maryland 21287 United States
    • Towson Maryland 21204 United States
    • Boston Massachusetts 02111 United States
    • Boston Massachusetts 02114 United States
    • Boston Massachusetts 02215 United States
    • Burlington Massachusetts 01805 United States
    • Detroit Michigan 48202 United States
    • Billings Montana 59102 United States
    • Omaha Nebraska 68130-5606 United States
    • Lebanon New Hampshire 03756-0001 United States
    • Englewood New Jersey 07361 United States
    • Hackensack New Jersey 07601 United States
    • Voorhees New Jersey 08043 United States
    • Albuquerque New Mexico 87109 United States
    • Bronx New York 10467-2490 United States
    • Buffalo New York 14263-0001 United States
    • New Hyde Park New York 11042 United States
    • New York New York 10032 United States
    • New York New York United States
    • Poughkeepsie New York 12601 United States
    • Rochester New York 14642 United States
    • Syracuse New York 13210 United States
    • Concord North Carolina 28025 United States
    • Winston-Salem North Carolina 27157 United States
    • Cleveland Ohio 44106-2602 United States
    • Columbus Ohio 43210 United States
    • Columbus Ohio 43221-2416 United States
    • Kettering Ohio 45409-1328 United States
    • Oklahoma City Oklahoma 73104 United States
    • Bala-Cynwyd Pennsylvania 19004 United States
    • Camp Hill Pennsylvania 17011 United States
    • Ephrata Pennsylvania 17522-1761 United States
    • Hershey Pennsylvania 17033 United States
    • Philadelphia Pennsylvania 19111-2497 United States
    • Pittsburgh Pennsylvania 15212 United States
    • Providence Rhode Island 02906 United States
    • Charleston South Carolina 29401-5799 United States
    • Charleston South Carolina 29414 United States
    • Greenville South Carolina 29607 United States
    • Myrtle Beach South Carolina 29572 United States
    • North Charleston South Carolina 29406 United States
    • Nashville Tennessee 37209 United States
    • Nashville Tennessee 37232-0021 United States
    • Dallas Texas 75231 United States
    • Houston Texas 77030 United States
    • Temple Texas 76508 United States
    • Salt Lake City Utah 84112 United States
    • Charlottesville Virginia 22908 United States
    • Fairfax Virginia 22031 United States
    • Richmond Virginia 23219 United States
    • Everett Washington 98201 United States
    • Seattle Washington 98101-2756 United States
    • Seattle Washington 98109-1023 United States
    • Milwaukee Wisconsin 53226 United States
    • Randwick New South Wales 2031 Australia
    • Sydney New South Wales 2010 Australia
    • Adelaide South Australia 5000 Australia
    • Melbourne Victoria 3065 Australia
    • Richmond Victoria 3122 Australia
    • Nedlands Western Australia 6009 Australia
    • Kurralta Park 5037 Australia
    • Wilrijk Antwerpen 2610 Belgium
    • Antwerpen 2020 Belgium
    • Bruxelles - Brussel 1000 Belgium
    • Bruxelles - Brussel 1070 Belgium
    • Bruxelles - Brussel 1200 Belgium
    • Charleroi 6000 Belgium
    • Gent 9000 Belgium
    • Namur 5000 Belgium
    • Salvador Bahia 41253-190 Brazil
    • Cachoeiro de Itapemirim Espírito Santo 29308-020 Brazil
    • Belo Horizonte Minas Gerais 30130-100 Brazil
    • Belo Horizonte Minas Gerais 30150-320 Brazil
    • Curitiba Parana 81520-060 Brazil
    • Natal Rio Grande Do Norte 59062-000 Brazil
    • Porto Alegre Rio Grande Do Sul 90050 170 Brazil
    • Santo André Sao Paulo 09060-650 Brazil
    • São Paulo Sao Paulo 01246-000 Brazil
    • São Paulo Sao Paulo 03102 002 Brazil
    • Rio de Janeiro 20231-050 Brazil
    • Rio de Janeiro 22793-080 Brazil
    • Sao Paulo 01308-050 Brazil
    • Sao Paulo 05651-901 Brazil
    • Gabrovo 5300 Bulgaria
    • Pleven 5800 Bulgaria
    • Plovdiv 4004 Bulgaria
    • Sofia 1303 Bulgaria
    • Sofia 1431 Bulgaria
    • Sofia 1784 Bulgaria
    • Varna 2010 Bulgaria
    • Vratsa 3000 Bulgaria
    • Calgary Alberta T2N 4N2 Canada
    • Edmonton Alberta T6G 1Z2 Canada
    • Toronto Ontario M4N 3M5 Canada
    • Toronto Ontario M5G 2M9 Canada
    • Montreal Quebec H2L 4M1 Canada
    • Hefei Anhui 230001 China
    • Xiamen Fujian 361003 China
    • Guangzhou Guangdong 510120 China
    • Shijiazhuang Hebei 050000 China
    • Zhengzhou Henan 450008 China
    • Wuhan Hubei 430030 China
    • Wuhan Hubei 430079 China
    • Changsha Hunan 410011 China
    • Changsha Hunan 410013 China
    • Nanjing Jiangsu 210008 China
    • Nanjing Jiangsu 210009 China
    • Nanchang Jiangxi 330006 China
    • Changchun Jilin 130021 China
    • Shengyang Liaoning 110042 China
    • Shenyang Liaoning 110001 China
    • Xi'an Shaanxi 710061 China
    • Jinan Shandong 250012 China
    • Jinan Shandong 250021 China
    • Yantai Shandong 264000 China
    • Hangzhou Zhejiang 310009 China
    • Hangzhou Zhejiang 310014 China
    • Wenzhou Zhejiang 325000 China
    • Beijing 100034 China
    • Beijing 100050 China
    • Beijing 100142 China
    • Beijing 100191 China
    • Beijing 100730 China
    • Beijing 100730 China
    • Chongqing 400030 China
    • Shanghai 200032 China
    • Shanghai 200040 China
    • Shanghai 200072 China
    • Shanghai 200080 China
    • Shanghai 200092 China
    • Tianjin 300052 China
    • Tianjin 300060 China
    • Brno 656 53 Czechia
    • Brno 656 91 Czechia
    • Hradec Kralove 500 05 Czechia
    • Praha 10 10034 Czechia
    • Praha 2 120 00 Czechia
    • Praha 2 128 08 Czechia
    • Praha 5 150 06 Czechia
    • Praha 8 180 01 Czechia
    • Helsinki 00029 Finland
    • Jyväskylä 40620 Finland
    • Kuopio 70210 Finland
    • Mikkeli FIN-50100 Finland
    • Oulu 90220 Finland
    • Tampere 33521 Finland
    • Turku 20520 Finland
    • Angers Cedex 49933 France
    • Besancon 25030 France
    • Bordeaux Cedex 33076 France
    • Brest 29200 France
    • Caen Cedex 5 14076 France
    • Clermont-ferrand 63011 France
    • Creteil 94010 France
    • Dijon 21000 France
    • Marseille 13273 France
    • Montpellier Cedex 34298 France
    • Nancy 54100 France
    • PARIS cedex 5 75248 France
    • Paris 75674 France
    • Pierre Benite 69495 France
    • Poitiers 86021 France
    • Pontoise 95301 France
    • Reims 51056 France
    • Saint Herblain Cedex 44805 France
    • Saint Mande 94160 France
    • Saint-gregoire 35760 France
    • Strasbourg 67098 France
    • Villejuif Cedex 94805 France
    • Freiburg Baden-Württemberg 79106 Germany
    • Reutlingen Baden-Württemberg 72766 Germany
    • Tübingen Baden-Württemberg 72076 Germany
    • Ulm Baden-Württemberg 89075 Germany
    • Erlangen Bayern 91054 Germany
    • Rostock Mecklenburg-Vorpommern 18107 Germany
    • Braunschweig Niedersachsen 38118 Germany
    • Düsseldorf Nordrhein-Westfalen 40225 Germany
    • Köln Nordrhein-Westfalen 50931 Germany
    • Münster Nordrhein-Westfalen 48149 Germany
    • Homburg Saarland 66421 Germany
    • Dresden Sachsen 01307 Germany
    • Jena Thüringen 07740 Germany
    • Berlin 12200 Germany
    • Magdeburg 39120 Germany
    • Beer Sheva 8410101 Israel
    • Haifa 3109601 Israel
    • Holon 5810001 Israel
    • Jerusalem 9103102 Israel
    • Jerusalem 9112001 Israel
    • Petah Tikva 4941492 Israel
    • Tel Aviv 6423906 Israel
    • Zefat 1311001 Israel
    • Zerifin 6093000 Israel
    • Bologna Emilia-Romagna 40138 Italy
    • Parma Emilia-Romagna 43126 Italy
    • Roma Lazio 00152 Italy
    • Roma Lazio 00161 Italy
    • Milano Lombardia 20141 Italy
    • Novara Piemonte 28100 Italy
    • Torino Piemonte 10043 Italy
    • Bari Puglia 70124 Italy
    • Arezzo Toscana 52100 Italy
    • Trento Trentino-Alto Adige 38122 Italy
    • Padova Veneto 35128 Italy
    • Verona Veneto 37134 Italy
    • Nagoya Aichi 466-8560 Japan
    • Hirosaki Aomori 036-8563 Japan
    • Asahi Chiba 289-2511 Japan
    • Kashiwa Chiba 277-8577 Japan
    • Sakura Chiba 285-8741 Japan
    • Matsuyama Ehime 791-0280 Japan
    • Sapporo Hokkaido 003-0804 Japan
    • Kobe Hyogo 650-0017 Japan
    • Kanazawa Ishikawa 920-8530 Japan
    • Kanazawa Ishikawa 920-8641 Japan
    • Kita Kagawa 761-0793 Japan
    • Yokohama Kanagawa 232-0024 Japan
    • Yokohama Kanagawa 241-8515 Japan
    • Tsu Mie 514-8507 Japan
    • Sendai Miyagi 980-8574 Japan
    • Kashihara Nara 634-8522 Japan
    • Osakasayama Osaka 589-8511 Japan
    • Suita Osaka 565-0871 Japan
    • Hamamatsu Shizuoka 431-3192 Japan
    • Shimotsuke Tochigi 329-0498 Japan
    • Utsunomiya Tochigi 321-0974 Japan
    • Bunkyo-ku Tokyo 113-8431 Japan
    • Bunkyo-ku Tokyo 113-8603 Japan
    • Bunkyo-ku Tokyo 113-8655 Japan
    • Koto-ku Tokyo 135-8550 Japan
    • Meguro-ku Tokyo 152-8902 Japan
    • Minato-ku Tokyo 105-8471 Japan
    • Mitaka Tokyo 181-8611 Japan
    • Nakano-ku Tokyo 164-8541 Japan
    • Shinjuku-ku Tokyo 160-8582 Japan
    • Shinjuku-ku Tokyo 162-8543 Japan
    • Yonago Tottori 683-8504 Japan
    • Ube Yamaguchi 755-8505 Japan
    • Chiba 260-8677 Japan
    • Chiba 260-8717 Japan
    • Fukuoka 811-1395 Japan
    • Gifu 500-8717 Japan
    • Kumamoto 860-0008 Japan
    • Miyazaki 889-1692 Japan
    • Nagasaki 852-8501 Japan
    • Okayama 700-8558 Japan
    • Osaka 541-8567 Japan
    • Osaka 545-8586 Japan
    • Tokushima 770-8503 Japan
    • Wakayama 641-8509 Japan
    • Donggu, Gwangju Gwang''yeogsi 501-757 Korea, Republic of
    • Seongnam-si Gyeonggido 463-707 Korea, Republic of
    • Seoul Seoul Teugbyeolsi 135-720 Korea, Republic of
    • Busan 614-735 Korea, Republic of
    • Daegu 41404 Korea, Republic of
    • Gyeonggi-do 471-701 Korea, Republic of
    • Seoul 03080 Korea, Republic of
    • Seoul 05505 Korea, Republic of
    • Seoul 120-752 Korea, Republic of
    • Seoul 135-710 Korea, Republic of
    • Seoul 136-705 Korea, Republic of
    • Seoul 137-701 Korea, Republic of
    • Ciudad de Mexico Distrito Federal 06760 Mexico
    • Mexico Distrito Federal 06700 Mexico
    • México Distrito Federal 14080 Mexico
    • Cuernavaca Morelos 62290 Mexico
    • Monterrey Nuevo Leon 64460 Mexico
    • Mazatlán Sinaloa 82110 Mexico
    • Cuautitlan Izcalli 54769 Mexico
    • Durango 34000 Mexico
    • Mexico CP 14050 Mexico
    • Querétaro 76000 Mexico
    • Amsterdam 1066 CX Netherlands
    • Amsterdam 1105 AZ Netherlands
    • Den Haag 2545 CH Netherlands
    • Dordrecht 3318 AT Netherlands
    • Heerlen 6401 CX Netherlands
    • Hilversum 1213 XZ Netherlands
    • Hoofddorp 2134 TM Netherlands
    • Nijmegen 6525 GA Netherlands
    • Tilburg 5042 AD Netherlands
    • Bydgoszcz 85-165 Poland
    • Lodz 93-513 Poland
    • Lublin 20-362 Poland
    • Poznan 60-569 Poland
    • Rybnik 44-200 Poland
    • Siedlce 08-110 Poland
    • Waliszew 05-135 Poland
    • Warszawa 02-781 Poland
    • Wroclaw 50 - 556 Poland
    • Barnaul 656049 Russian Federation
    • Chelyabinsk 454048 Russian Federation
    • Chelyabinsk 454087 Russian Federation
    • Moscow 115478 Russian Federation
    • Moscow 119435 Russian Federation
    • Moscow 125284 Russian Federation
    • Novosibirsk 630099 Russian Federation
    • Omsk 644013 Russian Federation
    • St. Petersburg 191104 Russian Federation
    • St. Petersburg 194017 Russian Federation
    • St. Petersburg 197022 Russian Federation
    • St. Petersburg 197136 Russian Federation
    • Sabadell Barcelona 08208 Spain
    • Palma de Mallorca Illes Baleares 07120 Spain
    • Barcelona 08003 Spain
    • Barcelona 08025 Spain
    • Barcelona 08035 Spain
    • Barcelona 08036 Spain
    • Cáceres 10003 Spain
    • Córdoba 14004 Spain
    • Lugo 27004 Spain
    • Madrid 28007 Spain
    • Madrid 28034 Spain
    • Madrid 28041 Spain
    • Madrid 28046 Spain
    • Málaga 29010 Spain
    • Valencia 46009 Spain
    • Göteborg 413 45 Sweden
    • Lund 221 85 Sweden
    • Stockholm 118 83 Sweden
    • Stockholm 171 76 Sweden
    • Umeå 901 85 Sweden
    • Uppsala 751 85 Sweden
    • Kaohsiung 807 Taiwan
    • Kaohsiung 833 Taiwan
    • Taichung 40447 Taiwan
    • Taipei 10002 Taiwan
    • Taipei 11217 Taiwan
    • Taoyuan 333 Taiwan
    • Colchester Essex CO4 5JR United Kingdom
    • Romford Essex RM7 0AG United Kingdom
    • Middlesborough North Yorkshire TS4 3BW United Kingdom
    • Oxford Oxfordshire OX3 7LJ United Kingdom
    • Belfast BT9 7AB United Kingdom
    • Glasgow G12 0YN United Kingdom
    • London NW1 2PG United Kingdom
    • London SW3 6JJ United Kingdom
    • London W6 8RF United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer

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    ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer


    Condition: Castration-Sensitive Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer, Stage IVA Prostate Cancer, Stage IVB Prostate Cancer

    Intervention:

    • Drug: Abiraterone Acetate
    • Drug: Antiandrogen Therapy
    • Drug: Docetaxel
    • Drug: Prednisone
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration

    Purpose: This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03827473

    Sponsor: University of Utah

    Primary Outcome Measures:

    • Measure: Change in Quality of Life
    • Time Frame: screening to month 12 of treatment
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Prostate-specific antigen (PSA) response
    • Time Frame: Up to 18 months
    • Safety Issue:
    • Measure: FACT/GOG-NTX Quality of Life Assessment
    • Time Frame: Up to 18 months
    • Safety Issue:
    • Measure: PROMIS-Fatigue Quality of Life Assessment
    • Time Frame: Up to 18 months
    • Safety Issue:
    • Measure: PSA progression free survival (PSA-PFS) between treatment arms
    • Time Frame: Up to 18 months
    • Safety Issue:

    Estimated Enrollment: 89

    Study Start Date: February 8, 2019

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically diagnosed adenocarcinoma of the prostate.
    • Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone scan) or molecular imaging (fluciclovine-PET/CT, PSMA-PET/CT, Choline-PET/CT etc).
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
    • Absolute neutrophil count (ANC) >= 1.5 k/uL.
    • Platelets >= 100 k/uL.
    • Hemoglobin >= 9 g/dL.
    • Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ? ULN.
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 ? ULN OR =< 4 ? ULN for subjects with liver metastases.
    • Creatinine < 1.5 x ULN OR
    • Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 x ULN by Cockcroft-Gault fomula or standard institutional practice.
    • Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.
    • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
    • Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as defined by the treating physician.

    Exclusion Criteria:

    • No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy (example: bicalutamide) is allowed.
    • Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).
    • Patients have a histologic diagnosis of small cell prostate cancer or pure squamous cell prostate cancer.
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
    • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    • Cardiovascular disorders:
    • Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.
    • Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic event within 3 months before first dose.
    • Other clinically significant disorders that would preclude safe study participation. As defined by the treating physician.
    • Known history of testing positive for human immunodeficiency virus (HIV) and CD4 count is below 200 or known acquired immunodeficiency syndrome diagnosis.
    • Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive) and a detectable viral count at screening.
    • Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use while on trial for the duration of potential docetaxel treatment. Live vaccine use is acceptable after chemotherapy or for patients randomized to the abiraterone arm. There are no restrictions on inactive viruses.
    • Known prior severe hypersensitivity to investigational product or any component in its formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).

    Contact:

    • Grace Humiston
    • 801-587-4645

    Location:

    • Huntsman Cancer Institute/University of Utah
    • Salt Lake City Utah 84112 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • Bone Response After Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients With Hormone Sensitive Metastatic Bone Disease: a Prospective, Phase II, Randomized, Multicenter Study

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    Bone Response After Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients With Hormone Sensitive Metastatic Bone Disease: a Prospective, Phase II, Randomized, Multicenter Study


    Condition: Prostate Cancer, Bone Metastases

    Intervention:

    • Drug: Zoledronic Acid
    • Drug: Enzalutamide

    Purpose: This study was undertaken to evaluate bone response in metastatic prostate cancer patients treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing hormone-releasing hormone (LHRH) analogue with the use of Whole Boby (WB) DW-MRI.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03336983

    Sponsor: Azienda Ospedaliera Spedali Civili di Brescia

    Primary Outcome Measures:

    • Measure: Evaluation of change in bone response after 6 and 12 months of treatment compared to baseline
    • Time Frame: Exam will be performed at baseline and after 6 and 12 months of treatment
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Evaluation of bone repair
    • Time Frame: Screening visit; 12 months of treatment
    • Safety Issue:
    • Measure: Changes in bone mineral density after 18 months of treatment compared to baseline
    • Time Frame: Screening visit; 18 months of treatment
    • Safety Issue:
    • Measure: Functional Assessment of Cancer Therapy-Prostate
    • Time Frame: Monthly until end of treatment (18 months)
    • Safety Issue:
    • Measure: Brief Pain Inventory-Short Form Questionnaire
    • Time Frame: Monthly until end of treatment (18 months)
    • Safety Issue:
    • Measure: Weight evaluation
    • Time Frame: Screening visit; 18 months of treatment
    • Safety Issue:
    • Measure: C-terminal telopeptide analysis
    • Time Frame: Screening visit; 2, 4, 6, 9, 12, 18 months of treatment
    • Safety Issue:
    • Measure: Bone alkaline phosphatase analysis
    • Time Frame: Screening visit; 2, 4, 6, 9, 12, 18 months of treatment
    • Safety Issue:

    Estimated Enrollment: 120

    Study Start Date: December 1, 2017

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Histological diagnosis of prostate carcinoma, 2. Age > 18 years, 3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at computed tomography (CT) scan or Magnetic Resonance Imaging (MRI), 4. No previous hormone or chemotherapeutic treatments given for prostate carcinoma (patients that are receiving LHRH-A therapy for less than 4 months are admitted), 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0
    • 1, 6. Expected life expectancy ≥ 6 months, 7. Subject capable to swallow the Study's medication and to comply with the Study's requirements, 8. Signed informed consent.

    Exclusion Criteria:

    • 1. Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make (at the discretion of the clinical Investigator), 2. Known or suspected brain metastases or active leptomeningeal dissemination, 3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma, 4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening), 5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x upper limit of normal (ULN) at Screening Visit, 6. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit, 7. Albumin ≤ 30 g/L (≤ 3,0 g/dL) at Screening Visit, 8. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit, 9. Clinically significant cardiovascular disease including:
    • myocardial infarction (6 months preceding the screening)
    • uncontrolled angina (3 months preceding the screening)
    • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
    • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
    • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
    • Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit;
    • Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
    • Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit; 10. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months); 11. Major surgery within 4 weeks of enrollment (Day 1 Visit); 12. Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit); 13. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease Prostate-specific antigen (PSA) levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit); 14. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

    Contact:

    • Alfredo Berruti, MD
    • 030399 Ext. 5410

    Location:

    • Azienda Ospedaliera Spedali Civili di Brescia
    • Brescia 25123 Italy

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published March 24, 2019
  • Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

    {{header-clinical-trials-navigation}}

    Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial


    Condition: Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma in the Soft Tissue, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Adenocarcinoma AJCC v7

    Intervention:

    • Drug: Abiraterone Acetate
    • Drug: Antiandrogen Therapy
    • Drug: Cabazitaxel
    • Other: Laboratory Biomarker Analysis
    • Procedure: Orchiectomy
    • Other: Pharmacological Study
    • Drug: Prednisone

    Purpose: This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03419234

    Sponsor: ECOG-ACRIN Cancer Research Group

    Primary Outcome Measures:

    • Measure: Progression free survival (PFS)
    • Time Frame: From randomization to radiographic progression, symptomatic deterioration or death, whichever occurs first, assessed for up to 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Percent change in PSA in serum
    • Time Frame: Baseline to 12 weeks
    • Safety Issue:
    • Measure: Maximum decline in PSA while on treatment
    • Time Frame: Baseline up to 30 days from last treatment on study
    • Safety Issue:
    • Measure: Time to PSA progression
    • Time Frame: Time from randomization to PSA progression, assessed for up to 30 days from last treatment on study
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: Time from randomization to time of death or date last known alive, assessed for up to 5 years
    • Safety Issue:
    • Measure: Radiographic response (complete and partial response) assessed per Response Evaluation Criteria in Solid Tumors 1.1
    • Time Frame: Up to 5 years
    • Safety Issue:
    • Measure: Incidence of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
    • Time Frame: Up to 30 days from last treatment on study
    • Safety Issue:

    Estimated Enrollment: 210

    Study Start Date: February 8, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
    • Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
    • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/magnetic resonance imaging [MRI] of abdomen/pelvis, bone scintigraphy or NaF PET/CT)
    • Ability to swallow abiraterone acetate tablets as a whole
    • All patients must be receiving standard of care androgen deprivation treatment (surgical castration versus LHRH agonist or antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time on this study
    • Patients must have castrate serum level of testosterone of < 50 ng/dL (< 1.73 nmol/L)
    • Patients must have progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for PSA, measurable disease or non-measurable (bone) disease during treatment with ADT:
    • PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value >= 2.0 ng/mL
    • Measurable disease (by RECIST 1.1): > 20% increase in the sum of the longest diameters of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be more that 15 mm to be assessed for change in size
    • Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or NaF PET/CT) consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI)
    • Patients may or may not have been treated previously with a nonsteroidal antiandrogen, such as flutamide, bicalutamide or nilutamide; for patients previously treated with an antiandrogen, they must be off treatment for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration and must have shown PSA progression after discontinuing the anti-androgen
    • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • Absolute neutrophil count (ANC) >= 1500/mm^3
    • Hemoglobin (HgB) >= 9.0 gr/dL
    • Platelets >= 100,000/mm^3
    • Creatinine < 2.0 mg/dL
    • Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding
    • Patients with resected or irradiated brain metastases or those treated with stereotactic radiation therapy are eligible to enroll, provided that they do not require treatment with steroids that exceeds 10 mg of prednisone daily or equivalent
    • Sexually active males must use an accepted and effective method of double barrier contraception or abstain from sexual intercourse for the duration of their participation in the study and for 26 weeks after the last dose of study drug
    • NaF PET/CT OPTIONAL SUB-STUDY

    Eligibility Criteria:

    • Ability to lie still for imaging
    • Weight =< 300 lbs (pounds)

    Exclusion Criteria:

    • Any prior chemotherapy or androgen receptor (AR)-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone acetate, ketoconazole, or enzalutamide); previous treatment with radium-223 or sipuleucel-T is allowed
    • Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate
    • Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy; concurrent treatment with agents to prevent skeletal-related events (such as zoledronic acid or denosumab) will be allowed as long as it was initiated prior to study entry
    • Any medical condition for which prednisone (corticosteroid) is contraindicated
    • If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert?s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
    • Alanine (ALT) or aspartate (AST) aminotransferase > 1.5 x ULN
    • Active infection requiring treatment with antibiotics
    • History of adrenal insufficiency or hypoaldosteronism
    • Myocardial infarction or arterial thrombotic event within 6 months, heart failure of New York Heart Association class II or higher, uncontrolled angina, severe uncontrolled ventricular arrhythmia
    • External beam radiation therapy within 4 weeks of registration
    • Prior history of allergic reactions to G-CSF
    • Prior history of allergic reactions to docetaxel and/or to medications formulated with polysorbate 80
    • History of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for 3 years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participate
    • Life expectancy of < 12 months at screening
    • Grade >= 2 neuropathy

    Locations:

    • CHI Saint Vincent Cancer Center Hot Springs
    • Hot Springs Arkansas 71913 United States
    • PCR Oncology
    • Arroyo Grande California 93420 United States
    • Sutter Auburn Faith Hospital
    • Auburn California 95602 United States
    • Sutter Cancer Centers Radiation Oncology Services-Auburn
    • Auburn California 95603 United States
    • Alta Bates Summit Medical Center-Herrick Campus
    • Berkeley California 94704 United States
    • Mills-Peninsula Medical Center
    • Burlingame California 94010 United States
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    • Cameron Park California 95682 United States
    • Eden Hospital Medical Center
    • Castro Valley California 94546 United States
    • Sutter Davis Hospital
    • Davis California 95616 United States
    • Palo Alto Medical Foundation-Fremont
    • Fremont California 94538 United States
    • Memorial Medical Center
    • Modesto California 95355 United States
    • Palo Alto Medical Foundation-Camino Division
    • Mountain View California 94040 United States
    • Palo Alto Medical Foundation-Gynecologic Oncology
    • Mountain View California 94040 United States
    • Sutter Cancer Research Consortium
    • Novato California 94945 United States
    • Palo Alto Medical Foundation Health Care
    • Palo Alto California 94301 United States
    • Feather River Cancer Center
    • Paradise California 95969 United States
    • Sutter Cancer Centers Radiation Oncology Services-Roseville
    • Roseville California 95661 United States
    • Sutter Roseville Medical Center
    • Roseville California 95661 United States
    • Sutter Medical Center Sacramento
    • Sacramento California 95816 United States
    • California Pacific Medical Center-Pacific Campus
    • San Francisco California 94115 United States
    • Palo Alto Medical Foundation-Santa Cruz
    • Santa Cruz California 95065 United States
    • Sutter Pacific Medical Foundation
    • Santa Rosa California 95403 United States
    • Palo Alto Medical Foundation-Sunnyvale
    • Sunnyvale California 94086 United States
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    • Vacaville California 95687 United States
    • Sutter Solano Medical Center/Cancer Center
    • Vallejo California 94589 United States
    • Rocky Mountain Cancer Centers-Aurora
    • Aurora Colorado 80012 United States
    • Boulder Community Hospital
    • Boulder Colorado 80301 United States
    • Rocky Mountain Cancer Centers-Boulder
    • Boulder Colorado 80304 United States
    • Penrose-Saint Francis Healthcare
    • Colorado Springs Colorado 80907 United States
    • Rocky Mountain Cancer Centers-Penrose
    • Colorado Springs Colorado 80907 United States
    • Denver Health Medical Center
    • Denver Colorado 80204 United States
    • National Jewish Health-Main Campus
    • Denver Colorado 80206 United States
    • The Women's Imaging Center
    • Denver Colorado 80209 United States
    • Porter Adventist Hospital
    • Denver Colorado 80210 United States
    • Colorado Blood Cancer Institute
    • Denver Colorado 80218 United States
    • Presbyterian - Saint Lukes Medical Center - Health One
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Midtown
    • Denver Colorado 80218 United States
    • SCL Health Saint Joseph Hospital
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Rose
    • Denver Colorado 80220 United States
    • Rose Medical Center
    • Denver Colorado 80220 United States
    • Western Surgical Care
    • Denver Colorado 80220 United States
    • Mercy Medical Center
    • Durango Colorado 81301 United States
    • Southwest Oncology PC
    • Durango Colorado 81301 United States
    • Comprehensive Cancer Care and Research Institute of Colorado LLC
    • Englewood Colorado 80113 United States
    • Swedish Medical Center
    • Englewood Colorado 80113 United States
    • Mountain Blue Cancer Care Center
    • Golden Colorado 80401 United States
    • National Jewish Health-Western Hematology Oncology
    • Golden Colorado 80401 United States
    • Grand Valley Oncology
    • Grand Junction Colorado 81501 United States
    • Saint Mary's Hospital and Regional Medical Center
    • Grand Junction Colorado 81501 United States
    • North Colorado Medical Center
    • Greeley Colorado 80631 United States
    • Good Samaritan Medical Center
    • Lafayette Colorado 80026 United States
    • Rocky Mountain Cancer Centers-Lakewood
    • Lakewood Colorado 80228 United States
    • Saint Anthony Hospital
    • Lakewood Colorado 80228 United States
    • Rocky Mountain Cancer Centers-Littleton
    • Littleton Colorado 80120 United States
    • Littleton Adventist Hospital
    • Littleton Colorado 80122 United States
    • Rocky Mountain Cancer Centers-Sky Ridge
    • Lone Tree Colorado 80124 United States
    • Longmont United Hospital
    • Longmont Colorado 80501 United States
    • Rocky Mountain Cancer Centers-Longmont
    • Longmont Colorado 80501 United States
    • McKee Medical Center
    • Loveland Colorado 80539 United States
    • Parker Adventist Hospital
    • Parker Colorado 80138 United States
    • Rocky Mountain Cancer Centers-Parker
    • Parker Colorado 80138 United States
    • Saint Mary Corwin Medical Center
    • Pueblo Colorado 81004 United States
    • Rocky Mountain Cancer Centers - Pueblo
    • Pueblo Colorado 81008 United States
    • National Jewish Health-Northern Hematology Oncology
    • Thornton Colorado 80260 United States
    • Rocky Mountain Cancer Centers-Thornton
    • Thornton Colorado 80260 United States
    • SCL Health Lutheran Medical Center
    • Wheat Ridge Colorado 80033 United States
    • Middlesex Hospital
    • Middletown Connecticut 06457 United States
    • Sibley Memorial Hospital
    • Washington District of Columbia 20016 United States
    • Hawaii Oncology Inc-Pali Momi
    • 'Aiea Hawaii 96701 United States
    • Pali Momi Medical Center
    • 'Aiea Hawaii 96701 United States
    • The Cancer Center of Hawaii-Pali Momi
    • 'Aiea Hawaii 96701 United States
    • Hawaii Cancer Care Inc-POB II
    • Honolulu Hawaii 96813 United States
    • Hawaii Oncology Inc-POB I
    • Honolulu Hawaii 96813 United States
    • Island Urology
    • Honolulu Hawaii 96813 United States
    • Queen's Medical Center
    • Honolulu Hawaii 96813 United States
    • Straub Clinic and Hospital
    • Honolulu Hawaii 96813 United States
    • University of Hawaii Cancer Center
    • Honolulu Hawaii 96813 United States
    • Hawaii Cancer Care Inc-Liliha
    • Honolulu Hawaii 96817 United States
    • Hawaii Oncology Inc-Kuakini
    • Honolulu Hawaii 96817 United States
    • Kuakini Medical Center
    • Honolulu Hawaii 96817 United States
    • The Cancer Center of Hawaii-Liliha
    • Honolulu Hawaii 96817 United States
    • Kapiolani Medical Center for Women and Children
    • Honolulu Hawaii 96826 United States
    • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Lihue Hawaii 96766 United States
    • Kootenai Medical Center
    • Coeur d'Alene Idaho 83814 United States
    • Kootenai Cancer Center
    • Post Falls Idaho 83854 United States
    • Kootenai Cancer Clinic
    • Sandpoint Idaho 83864 United States
    • Rush - Copley Medical Center
    • Aurora Illinois 60504 United States
    • Illinois CancerCare-Bloomington
    • Bloomington Illinois 61704 United States
    • Illinois CancerCare-Canton
    • Canton Illinois 61520 United States
    • Memorial Hospital of Carbondale
    • Carbondale Illinois 62902 United States
    • SIH Cancer Institute
    • Carterville Illinois 62918 United States
    • Illinois CancerCare-Carthage
    • Carthage Illinois 62321 United States
    • Centralia Oncology Clinic
    • Centralia Illinois 62801 United States
    • Carle on Vermilion
    • Danville Illinois 61832 United States
    • Cancer Care Specialists of Central Illinois
    • Decatur Illinois 62526 United States
    • Decatur Memorial Hospital
    • Decatur Illinois 62526 United States
    • Carle Physician Group-Effingham
    • Effingham Illinois 62401 United States
    • Crossroads Cancer Center
    • Effingham Illinois 62401 United States
    • Illinois CancerCare-Eureka
    • Eureka Illinois 61530 United States
    • Illinois CancerCare-Galesburg
    • Galesburg Illinois 61401 United States
    • Western Illinois Cancer Treatment Center
    • Galesburg Illinois 61401 United States
    • Joliet Oncology-Hematology Associates Limited
    • Joliet Illinois 60435 United States
    • Illinois CancerCare-Kewanee Clinic
    • Kewanee Illinois 61443 United States
    • Illinois CancerCare-Macomb
    • Macomb Illinois 61455 United States
    • Carle Physician Group-Mattoon/Charleston
    • Mattoon Illinois 61938 United States
    • Good Samaritan Regional Health Center
    • Mount Vernon Illinois 62864 United States
    • Illinois CancerCare-Ottawa Clinic
    • Ottawa Illinois 61350 United States
    • Illinois CancerCare-Pekin
    • Pekin Illinois 61554 United States
    • Illinois CancerCare-Peoria
    • Peoria Illinois 61615 United States
    • Methodist Medical Center of Illinois
    • Peoria Illinois 61636 United States
    • Illinois CancerCare-Peru
    • Peru Illinois 61354 United States
    • Valley Radiation Oncology
    • Peru Illinois 61354 United States
    • Illinois CancerCare-Princeton
    • Princeton Illinois 61356 United States
    • Southern Illinois University School of Medicine
    • Springfield Illinois 62702 United States
    • Springfield Clinic
    • Springfield Illinois 62702 United States
    • Memorial Medical Center
    • Springfield Illinois 62781 United States
    • Cancer Care Specialists of Illinois-Swansea
    • Swansea Illinois 62226 United States
    • Memorial and Saint Elizabeth's Health Care Services LLP
    • Swansea Illinois 62226 United States
    • Carle Cancer Center
    • Urbana Illinois 61801 United States
    • The Carle Foundation Hospital
    • Urbana Illinois 61801 United States
    • Rush-Copley Healthcare Center
    • Yorkville Illinois 60560 United States
    • Parkview Hospital Randallia
    • Fort Wayne Indiana 46805 United States
    • Indiana University/Melvin and Bren Simon Cancer Center
    • Indianapolis Indiana 46202 United States
    • Sidney and Lois Eskenazi Hospital
    • Indianapolis Indiana 46202 United States
    • Memorial Regional Cancer Center Day Road
    • Mishawaka Indiana 46545 United States
    • Memorial Hospital of South Bend
    • South Bend Indiana 46601 United States
    • Mary Greeley Medical Center
    • Ames Iowa 50010 United States
    • McFarland Clinic PC - Ames
    • Ames Iowa 50010 United States
    • McFarland Clinic PC-Boone
    • Boone Iowa 50036 United States
    • Medical Oncology and Hematology Associates-West Des Moines
    • Clive Iowa 50325 United States
    • Mercy Cancer Center-West Lakes
    • Clive Iowa 50325 United States
    • Alegent Health Mercy Hospital
    • Council Bluffs Iowa 51503 United States
    • Greater Regional Medical Center
    • Creston Iowa 50801 United States
    • Iowa Methodist Medical Center
    • Des Moines Iowa 50309 United States
    • Medical Oncology and Hematology Associates-Des Moines
    • Des Moines Iowa 50309 United States
    • Broadlawns Medical Center
    • Des Moines Iowa 50314 United States
    • Medical Oncology and Hematology Associates-Laurel
    • Des Moines Iowa 50314 United States
    • Mercy Medical Center - Des Moines
    • Des Moines Iowa 50314 United States
    • Iowa Lutheran Hospital
    • Des Moines Iowa 50316 United States
    • McFarland Clinic PC-Trinity Cancer Center
    • Fort Dodge Iowa 50501 United States
    • Trinity Regional Medical Center
    • Fort Dodge Iowa 50501 United States
    • McFarland Clinic PC-Jefferson
    • Jefferson Iowa 50129 United States
    • McFarland Clinic PC-Marshalltown
    • Marshalltown Iowa 50158 United States
    • Methodist West Hospital
    • West Des Moines Iowa 50266-7700 United States
    • Mercy Medical Center-West Lakes
    • West Des Moines Iowa 50266 United States
    • Central Care Cancer Center - Garden City
    • Garden City Kansas 67846 United States
    • Central Care Cancer Center - Great Bend
    • Great Bend Kansas 67530 United States
    • Kansas Institute of Medicine Cancer and Blood Center
    • Lenexa Kansas 66219 United States
    • Minimally Invasive Surgery Hospital
    • Lenexa Kansas 66219 United States
    • Menorah Medical Center
    • Overland Park Kansas 66209 United States
    • Flaget Memorial Hospital
    • Bardstown Kentucky 40004 United States
    • Commonwealth Cancer Center-Corbin
    • Corbin Kentucky 40701 United States
    • Saint Joseph Radiation Oncology Resource Center
    • Lexington Kentucky 40504 United States
    • Saint Joseph Hospital East
    • Lexington Kentucky 40509 United States
    • University of Kentucky/Markey Cancer Center
    • Lexington Kentucky 40536 United States
    • Saint Joseph London
    • London Kentucky 40741 United States
    • Jewish Hospital
    • Louisville Kentucky 40202 United States
    • Saints Mary and Elizabeth Hospital
    • Louisville Kentucky 40215 United States
    • Jewish Hospital Medical Center Northeast
    • Louisville Kentucky 40245 United States
    • Jewish Hospital Medical Center South
    • Shepherdsville Kentucky 40165 United States
    • East Jefferson General Hospital
    • Metairie Louisiana 70006 United States
    • Louisiana State University Health Science Center
    • New Orleans Louisiana 70112 United States
    • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Baltimore Maryland 21287 United States
    • Hickman Cancer Center
    • Adrian Michigan 49221 United States
    • Toledo Clinic Cancer Centers-Monroe
    • Monroe Michigan 48162 United States
    • Huron Medical Center PC
    • Port Huron Michigan 48060 United States
    • Lake Huron Medical Center
    • Port Huron Michigan 48060 United States
    • Sanford Clinic North-Bemidgi
    • Bemidji Minnesota 56601 United States
    • Fairview Ridges Hospital
    • Burnsville Minnesota 55337 United States
    • Mercy Hospital
    • Coon Rapids Minnesota 55433 United States
    • Fairview-Southdale Hospital
    • Edina Minnesota 55435 United States
    • Unity Hospital
    • Fridley Minnesota 55432 United States
    • Fairview Maple Grove Medical Center
    • Maple Grove Minnesota 55369 United States
    • Minnesota Oncology Hematology PA-Maplewood
    • Maplewood Minnesota 55109 United States
    • Saint John's Hospital - Healtheast
    • Maplewood Minnesota 55109 United States
    • Abbott-Northwestern Hospital
    • Minneapolis Minnesota 55407 United States
    • Hennepin County Medical Center
    • Minneapolis Minnesota 55415 United States
    • Health Partners Inc
    • Minneapolis Minnesota 55454 United States
    • New Ulm Medical Center
    • New Ulm Minnesota 56073 United States
    • North Memorial Medical Health Center
    • Robbinsdale Minnesota 55422 United States
    • Park Nicollet Clinic - Saint Louis Park
    • Saint Louis Park Minnesota 55416 United States
    • Regions Hospital
    • Saint Paul Minnesota 55101 United States
    • United Hospital
    • Saint Paul Minnesota 55102 United States
    • Saint Francis Regional Medical Center
    • Shakopee Minnesota 55379 United States
    • Lakeview Hospital
    • Stillwater Minnesota 55082 United States
    • Ridgeview Medical Center
    • Waconia Minnesota 55387 United States
    • Rice Memorial Hospital
    • Willmar Minnesota 56201 United States
    • Minnesota Oncology Hematology PA-Woodbury
    • Woodbury Minnesota 55125 United States
    • Fairview Lakes Medical Center
    • Wyoming Minnesota 55092 United States
    • Saint Louis Cancer and Breast Institute-Ballwin
    • Ballwin Missouri 63011 United States
    • Central Care Cancer Center - Bolivar
    • Bolivar Missouri 65613 United States
    • Parkland Health Center-Bonne Terre
    • Bonne Terre Missouri 63628 United States
    • Cox Cancer Center Branson
    • Branson Missouri 65616 United States
    • Saint Francis Medical Center
    • Cape Girardeau Missouri 63703 United States
    • Southeast Cancer Center
    • Cape Girardeau Missouri 63703 United States
    • Siteman Cancer Center at West County Hospital
    • Creve Coeur Missouri 63141 United States
    • Centerpoint Medical Center LLC
    • Independence Missouri 64057 United States
    • Capital Region Southwest Campus
    • Jefferson City Missouri 65109 United States
    • Freeman Health System
    • Joplin Missouri 64804 United States
    • Mercy Hospital Joplin
    • Joplin Missouri 64804 United States
    • Research Medical Center
    • Kansas City Missouri 64132 United States
    • Delbert Day Cancer Institute at PCRMC
    • Rolla Missouri 65401 United States
    • Mercy Clinic-Rolla-Cancer and Hematology
    • Rolla Missouri 65401 United States
    • Heartland Regional Medical Center
    • Saint Joseph Missouri 64507 United States
    • Saint Louis Cancer and Breast Institute-South City
    • Saint Louis Missouri 63109 United States
    • Washington University School of Medicine
    • Saint Louis Missouri 63110 United States
    • Siteman Cancer Center-South County
    • Saint Louis Missouri 63129 United States
    • Missouri Baptist Medical Center
    • Saint Louis Missouri 63131 United States
    • Siteman Cancer Center at Christian Hospital
    • Saint Louis Missouri 63136 United States
    • Mercy Hospital Saint Louis
    • Saint Louis Missouri 63141 United States
    • Siteman Cancer Center at Saint Peters Hospital
    • Saint Peters Missouri 63376 United States
    • Sainte Genevieve County Memorial Hospital
    • Sainte Genevieve Missouri 63670 United States
    • Mercy Hospital Springfield
    • Springfield Missouri 65804 United States
    • CoxHealth South Hospital
    • Springfield Missouri 65807 United States
    • Missouri Baptist Sullivan Hospital
    • Sullivan Missouri 63080 United States
    • Missouri Baptist Outpatient Center-Sunset Hills
    • Sunset Hills Missouri 63127 United States
    • Mercy Hospital Washington
    • Washington Missouri 63090 United States
    • Community Hospital of Anaconda
    • Anaconda Montana 59711 United States
    • Billings Clinic Cancer Center
    • Billings Montana 59101 United States
    • Saint Vincent Healthcare
    • Billings Montana 59101 United States
    • Saint Vincent Frontier Cancer Center
    • Billings Montana 59102 United States
    • Bozeman Deaconess Hospital
    • Bozeman Montana 59715 United States
    • Benefis Healthcare- Sletten Cancer Institute
    • Great Falls Montana 59405 United States
    • Great Falls Clinic
    • Great Falls Montana 59405 United States
    • Saint Peter's Community Hospital
    • Helena Montana 59601 United States
    • Kalispell Regional Medical Center
    • Kalispell Montana 59901 United States
    • Community Medical Hospital
    • Missoula Montana 59804 United States
    • CHI Health Saint Francis
    • Grand Island Nebraska 68803 United States
    • Heartland Hematology and Oncology
    • Kearney Nebraska 68845 United States
    • CHI Health Good Samaritan
    • Kearney Nebraska 68847 United States
    • Saint Elizabeth Regional Medical Center
    • Lincoln Nebraska 68510 United States
    • Alegent Health Immanuel Medical Center
    • Omaha Nebraska 68122 United States
    • Hematology and Oncology Consultants PC
    • Omaha Nebraska 68122 United States
    • Alegent Health Bergan Mercy Medical Center
    • Omaha Nebraska 68124 United States
    • Alegent Health Lakeside Hospital
    • Omaha Nebraska 68130 United States
    • Creighton University Medical Center
    • Omaha Nebraska 68131 United States
    • Midlands Community Hospital
    • Papillion Nebraska 68046 United States
    • Carson Tahoe Regional Medical Center
    • Carson City Nevada 89703 United States
    • Cancer and Blood Specialists-Henderson
    • Henderson Nevada 89052 United States
    • Comprehensive Cancer Centers of Nevada - Henderson
    • Henderson Nevada 89052 United States
    • Comprehensive Cancer Centers of Nevada-Horizon Ridge
    • Henderson Nevada 89052 United States
    • Las Vegas Cancer Center-Henderson
    • Henderson Nevada 89052 United States
    • Nevada Cancer Specialists-Saint Rose
    • Henderson Nevada 89052 United States
    • 21st Century Oncology-Henderson
    • Henderson Nevada 89074 United States
    • Comprehensive Cancer Centers of Nevada-Southeast Henderson
    • Henderson Nevada 89074 United States
    • Desert West Surgery
    • Las Vegas Nevada 89102 United States
    • Nevada Cancer Specialists?Oakey
    • Las Vegas Nevada 89102 United States
    • University Medical Center of Southern Nevada
    • Las Vegas Nevada 89102 United States
    • Cancer and Blood Specialists-Shadow
    • Las Vegas Nevada 89106 United States
    • Radiation Oncology Centers of Nevada Central
    • Las Vegas Nevada 89106 United States
    • 21st Century Oncology
    • Las Vegas Nevada 89109 United States
    • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
    • Las Vegas Nevada 89109 United States
    • HealthCare Partners Medical Group Oncology/Hematology-San Martin
    • Las Vegas Nevada 89113 United States
    • Radiation Oncology Centers of Nevada Southeast
    • Las Vegas Nevada 89119 United States
    • Cancer Therapy and Integrative Medicine
    • Las Vegas Nevada 89121 United States
    • 21st Century Oncology-Vegas Tenaya
    • Las Vegas Nevada 89128 United States
    • Ann M Wierman MD LTD
    • Las Vegas Nevada 89128 United States
    • Cancer and Blood Specialists-Tenaya
    • Las Vegas Nevada 89128 United States
    • Comprehensive Cancer Centers of Nevada - Northwest
    • Las Vegas Nevada 89128 United States
    • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
    • Las Vegas Nevada 89128 United States
    • Nevada Cancer Specialists-Tenaya
    • Las Vegas Nevada 89128 United States
    • Comprehensive Cancer Centers of Nevada-Summerlin
    • Las Vegas Nevada 89144 United States
    • Summerlin Hospital Medical Center
    • Las Vegas Nevada 89144 United States
    • Las Vegas Cancer Center-Medical Center
    • Las Vegas Nevada 89148-2405 United States
    • 21st Century Oncology-Fort Apache
    • Las Vegas Nevada 89148 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89148 United States
    • Nevada Cancer Specialists-Fort Apache
    • Las Vegas Nevada 89148 United States
    • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
    • Las Vegas Nevada 89149 United States
    • Comprehensive Cancer Centers of Nevada - Central Valley
    • Las Vegas Nevada 89169 United States
    • University Cancer Center
    • Las Vegas Nevada 89169 United States
    • Hope Cancer Care of Nevada-Pahrump
    • Pahrump Nevada 89048 United States
    • Renown Regional Medical Center
    • Reno Nevada 89502 United States
    • Saint Mary's Regional Medical Center
    • Reno Nevada 89503 United States
    • Radiation Oncology Associates
    • Reno Nevada 89509 United States
    • Montefiore Medical Center-Einstein Campus
    • Bronx New York 10461 United States
    • Montefiore Medical Center-Weiler Hospital
    • Bronx New York 10461 United States
    • Montefiore Medical Center - Moses Campus
    • Bronx New York 10467 United States
    • Southeastern Medical Oncology Center-Clinton
    • Clinton North Carolina 28328 United States
    • Southeastern Medical Oncology Center-Goldsboro
    • Goldsboro North Carolina 27534 United States
    • Wayne Memorial Hospital
    • Goldsboro North Carolina 27534 United States
    • Onslow Memorial Hospital
    • Jacksonville North Carolina 28546 United States
    • Southeastern Medical Oncology Center-Jacksonville
    • Jacksonville North Carolina 28546 United States
    • Vidant Oncology-Kinston
    • Kinston North Carolina 28501 United States
    • Sanford Bismarck Medical Center
    • Bismarck North Dakota 58501 United States
    • Roger Maris Cancer Center
    • Fargo North Dakota 58122 United States
    • Sanford Broadway Medical Center
    • Fargo North Dakota 58122 United States
    • Good Samaritan Hospital - Cincinnati
    • Cincinnati Ohio 45220 United States
    • Bethesda North Hospital
    • Cincinnati Ohio 45242 United States
    • TriHealth Cancer Institute-Westside
    • Cincinnati Ohio 45247 United States
    • TriHealth Cancer Institute-Anderson
    • Cincinnati Ohio 45255 United States
    • Toledo Clinic Cancer Centers-Maumee
    • Maumee Ohio 43537 United States
    • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
    • Maumee Ohio 43537 United States
    • Mercy Health Perrysburg Cancer Center
    • Perrysburg Ohio 43551 United States
    • Mercy Saint Anne Hospital
    • Toledo Ohio 43623 United States
    • Toledo Clinic Cancer Centers-Toledo
    • Toledo Ohio 43623 United States
    • Cancer Centers of Southwest Oklahoma Research
    • Lawton Oklahoma 73505 United States
    • University of Oklahoma Health Sciences Center
    • Oklahoma City Oklahoma 73104 United States
    • Mercy Hospital Oklahoma City
    • Oklahoma City Oklahoma 73120 United States
    • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Tulsa Oklahoma 74146 United States
    • UPMC-Heritage Valley Health System Beaver
    • Beaver Pennsylvania 15009 United States
    • UPMC Cancer Centers - Arnold Palmer Pavilion
    • Greensburg Pennsylvania 15601 United States
    • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
    • Harrisburg Pennsylvania 17109 United States
    • UPMC-Johnstown/John P. Murtha Regional Cancer Center
    • Johnstown Pennsylvania 15901 United States
    • UPMC Cancer Center at UPMC McKeesport
    • McKeesport Pennsylvania 15132 United States
    • UPMC-Coraopolis/Heritage Valley Radiation Oncology
    • Moon Pennsylvania 15108 United States
    • ECOG-ACRIN Cancer Research Group
    • Philadelphia Pennsylvania 19103 United States
    • University of Pennsylvania/Abramson Cancer Center
    • Philadelphia Pennsylvania 19104 United States
    • Temple University Hospital
    • Philadelphia Pennsylvania 19140 United States
    • UPMC-Magee Womens Hospital
    • Pittsburgh Pennsylvania 15213 United States
    • UPMC-Presbyterian Hospital
    • Pittsburgh Pennsylvania 15213 United States
    • UPMC-Saint Margaret
    • Pittsburgh Pennsylvania 15215 United States
    • University of Pittsburgh Cancer Institute (UPCI)
    • Pittsburgh Pennsylvania 15232 United States
    • UPMC-Shadyside Hospital
    • Pittsburgh Pennsylvania 15232 United States
    • UPMC-Passavant Hospital
    • Pittsburgh Pennsylvania 15237 United States
    • UPMC-Saint Clair Hospital Cancer Center
    • Pittsburgh Pennsylvania 15243 United States
    • Guthrie Medical Group PC-Robert Packer Hospital
    • Sayre Pennsylvania 18840 United States
    • UPMC Cancer Center at UPMC Northwest
    • Seneca Pennsylvania 16346 United States
    • UPMC Uniontown Hospital Radiation Oncology
    • Uniontown Pennsylvania 15401 United States
    • UPMC Washington Hospital Radiation Oncology
    • Washington Pennsylvania 15301 United States
    • Reading Hospital
    • West Reading Pennsylvania 19611 United States
    • UPMC Susquehanna
    • Williamsport Pennsylvania 17701 United States
    • Sanford Cancer Center Oncology Clinic
    • Sioux Falls South Dakota 57104 United States
    • Sanford USD Medical Center - Sioux Falls
    • Sioux Falls South Dakota 57117-5134 United States
    • Wellmont Bristol Regional Medical Center
    • Bristol Tennessee 37620 United States
    • Memorial Hospital
    • Chattanooga Tennessee 37404 United States
    • Pulmonary Medicine Center of Chattanooga-Hixson
    • Hixson Tennessee 37343 United States
    • Wellmont Medical Associates Oncology and Hematology-Johnson City
    • Johnson City Tennessee 37604 United States
    • Wellmont Holston Valley Hospital and Medical Center
    • Kingsport Tennessee 37660 United States
    • Wellmont Medical Associates Oncology and Hematology-Kingsport
    • Kingsport Tennessee 37660 United States
    • Memorial GYN Plus
    • Ooltewah Tennessee 37363 United States
    • Saint Joseph Regional Cancer Center
    • Bryan Texas 77802 United States
    • M D Anderson Cancer Center
    • Houston Texas 77030 United States
    • MD Anderson Regional Care Center-Katy
    • Houston Texas 77094 United States
    • MD Anderson Regional Care Center-Bay Area
    • Nassau Bay Texas 77058 United States
    • MD Anderson Regional Care Center-Sugar Land
    • Sugar Land Texas 77478 United States
    • MD Anderson Regional Care Center-The Woodlands
    • The Woodlands Texas 77384 United States
    • Farmington Health Center
    • Farmington Utah 84025 United States
    • Huntsman Cancer Institute/University of Utah
    • Salt Lake City Utah 84112 United States
    • South Jordan Health Center
    • South Jordan Utah 84009 United States
    • Wellmont Medical Associates-Bristol
    • Bristol Virginia 24201 United States
    • Southwest VA Regional Cancer Center
    • Norton Virginia 24273 United States
    • Harrison HealthPartners Hematology and Oncology-Bremerton
    • Bremerton Washington 98310 United States
    • Harrison Medical Center
    • Bremerton Washington 98310 United States
    • Highline Medical Center-Main Campus
    • Burien Washington 98166 United States
    • Saint Elizabeth Hospital
    • Enumclaw Washington 98022 United States
    • Saint Francis Hospital
    • Federal Way Washington 98003 United States
    • Saint Clare Hospital
    • Lakewood Washington 98499 United States
    • Harrison HealthPartners Hematology and Oncology-Poulsbo
    • Poulsbo Washington 98370 United States
    • Franciscan Research Center-Northwest Medical Plaza
    • Tacoma Washington 98405 United States
    • Northwest Medical Specialties PLLC
    • Tacoma Washington 98405 United States
    • UW Cancer Center Johnson Creek
    • Johnson Creek Wisconsin 53038 United States
    • University of Wisconsin Hospital and Clinics
    • Madison Wisconsin 53792 United States
    • Cancer Center of Western Wisconsin
    • New Richmond Wisconsin 54017 United States
    • Cheyenne Regional Medical Center-West
    • Cheyenne Wyoming 82001 United States
    • Billings Clinic-Cody
    • Cody Wyoming 82414 United States
    • Welch Cancer Center
    • Sheridan Wyoming 82801 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy - an Exploratory Randomized Controlled Trial

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    Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy - an Exploratory Randomized Controlled Trial


    Condition: Fasting, Prostatic Neoplasms

    Intervention:

    • Other: Fasting
    • Other: Control

    Purpose: The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02710721

    Sponsor: Charite University, Berlin, Germany

    Primary Outcome Measures:

    • Measure: FACT-P/-Taxane/-An sum score
    • Time Frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: FACT-P/-Taxane/-An sum score
    • Time Frame: Assessment day 0 (baseline) and 3 and 6 months after day 0
    • Safety Issue:
    • Measure: HADS
    • Time Frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0
    • Safety Issue:

    Estimated Enrollment: 60

    Study Start Date: April 2016

    Eligibility:

    • Age: minimum 25 Years maximum 89 Years
    • Gender: Male

    Inclusion Criteria:

    • Diagnosis of CRPC or hormone-sensitive prostate cancer with high metastatic load
    • Cancer is treated to guidelines conventionally with chemotherapy or with a combination of hormone therapy and chemotherapy.

    Exclusion Criteria:

    • Underweight (BMI <20 kg/m2) or actual weight decrease >2 kg or >5 kg in the last 1 or 3 months.
    • Eating disorder
    • Dementia
    • Psychosis
    • Terminal illness with a significant limitation of mobility and overall vitality
    • Diabetes mellitus type 1
    • Renal insufficiency stage > 2, GFR <60mlmin / 1.73 m2

    Contact:

    • Andreas Michalsen, Prof. Dr.
    • +49 30 80505 691

    Location:

    • Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
    • Berlin 12200 Germany

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer

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    Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer


    Condition: Castration-Resistant Prostatic Cancer, Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, Hormone-Refractory Prostate Cancer

    Intervention:

    • Biological: GnRH agonist/antagonist
    • Drug: Prednisone
    • Drug: Abiraterone Acetate
    • Drug: Enzalutamide

    Purpose: This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03016741

    Sponsor: Northwestern University

    Primary Outcome Measures:

    • Measure: Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Quality of life assessed using European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ C-30)
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:
    • Measure: Fatigue assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT- Fatigue)
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:
    • Measure: Subjective measure of cognitive function by FACT-Cog
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:
    • Measure: Depression by Patient Health Questionnaire (PHQ-9)
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:
    • Measure: Instrumental activities of daily living by Texas Functional Living Scale
    • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
    • Safety Issue:

    Estimated Enrollment: 100

    Study Start Date: March 31, 2017

    Phase: Phase 4

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Have diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy for at least 1 month prior to enrollment.
    • Willing and able to complete survey questionnaires in English without assistance through the duration of the study. This stipulation is in place because not all of the proposed quality of life or cognitive tests are available or validated in other languages.
    • Age ≥ 18 years.
    • Ability to understand and the willingness to sign a written informed consent document written in English that is approved by an institutional review board.
    • Have either newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) or castration-resistant metastatic prostate cancer (mCRPC) and eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC) or enzalutamide (mCRPC)
    • Patients may have received the following prior AR directed therapy prior to enrollment: bicalutamide, ketoconazole. Prior to enrollment, patients may have received treatment with abiraterone acetate or enzalutamide for no more than 14 days before completing baseline studies.
    • Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer only, but it must not have lasted for more than 6 months. At least 12 months must have elapsed since completion of chemotherapy.
    • Patients may have received prior definitive radiation therapy or surgery. At least 60 days must have elapsed since completion of definitive radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration. Enrollment during palliative radiation of ≤ 10 days, or radiation of ≤ 10 days during the duration of the study is allowed.
    • Patients must be able to take oral medication.

    Exclusion Criteria:

    • Prior treatment with enzalutamide or abiraterone acetate for > 14 days prior to enrollment and completion of baseline tests.
    • Receipt of chemotherapy for prostate or other cancer within the past 12 months with residual cognitive deficits, or receipt of chemotherapy for mCRPC. Patients/physicians planning treatment with chemotherapy during the 12 month period of the investigation are also ineligible.
    • History of cognitive impairment or dysfunction, including a history of dementia, Alzheimer's disease, stroke with residual cognitive deficits, cognitive dysfunction related to alcohol or substance abuse, or cognitive dysfunction related to prior treatment for any cancer.
    • Patients with a seizure history, history of recurrent falls, or known brain metastases are excluded from this clinical trial because of their poor prognosis and because of their heightened risk of seizure or progressive cognitive and/or neurologic dysfunction that would confound the evaluation.
    • Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.
    • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a "currently active" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year. Patients with cognitive dysfunction related to treatment of another malignancy, including a history of "chemo-brain", are ineligible.
    • Patients taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. Appropriate treatment by a licensed provider with medications for depression or anxiety, including but not limited to SSRIs, SNRIs, and standard dose benzodiazepines at a stable dose, is permitted

    Contact:

    • Study Coordinator
    • (312)695-1301

    Locations:

    • City of Hope Comprehensive Cancer Center
    • Los Angeles California 91010 United States
    • Northwestern University
    • Chicago Illinois 60611 United States
    • Vanderbilt-Ingram Cancer Center
    • Nashville Tennessee 37232 United States

    View trial on ClinicalTrials.gov


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    Published November 27, 2017
  • Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells

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    Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells


    Condition: Prostate Cancer

    Intervention:

    • Other: Blood drawing

    Purpose: As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02723526

    Sponsor: Fudan University

    Primary Outcome Measures:

    • Measure: time to castration-resistant prostate cancer
    • Time Frame: 3 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: time to radiographic progression
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: time to prostate specific antigen (PSA) progression
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: time to prostate specific antigen (PSA) nadir
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: complete serologic response rate at 6 month and 12 month
    • Time Frame: 1 years
    • Safety Issue:

    Estimated Enrollment: 100

    Study Start Date: March 2016

    Eligibility:

    • Age: minimum 18 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    1. Male patients;
    2. 18 yrs and older, and 80 yrs and younger;
    3. Histologically or cytologically proven prostate adenocarcinoma;
    4. Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
    5. Not yet receiving hormonal therapy;
    6. Not yet receiving chemotherapy previously;
    7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
    8. Patients are willing to participate and can be followed up regularly;

    Exclusion Criteria:

    1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
    2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
    3. Patients received chemotherapy previously;
    4. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);

    Contact:

    • Bo Dai, MD
    • +86-21 64175590

    Location:

    • Fudan University Shanghai Cancer Center
    • Shanghai Shanghai 200032 China

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Docetaxel and Prostvac for Metastatic Castration Sensitive Prostate Cancer

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    Docetaxel and Prostvac for Metastatic Castration Sensitive Prostate Cancer


    Condition: Prostate Cancer, Prostate Neoplasms, Neoplasms, Prostatic

    Intervention:

    • Biological: PROSTVAC-V
    • Biological: PROSTVAC-F
    • Drug: Docetaxel

    Purpose: Background: Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think this may work better against prostate cancer than ADT alone. Objective: To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT alone. Eligibility: Men ages 18 years and over with metastatic castrate-sensitive prostate cancer Design: Participants will be screened with: Physical exam Medical history Blood tests Possible CT, MRI, or bone scan: Participants lie in a machine. The machine takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will have 2 optional tumor biopsies during the study. Participants will join 1 of 2 groups. Both groups will get: ADT Docetaxel by vein Steroids by mouth or vein before each docetaxel infusion PROSTVAC injection Both groups first have ADT. One to 4 months after, they have: Group A: Docetaxel every 3 weeks for 6 cycles PROSTVAC 3 weeks after the last infusion Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total Group B: PROSTVAC Booster 2 weeks later Docetaxel hours later Docetaxel and the booster every 3 weeks for 6 cycles Participants will have a visit 4-5 weeks after the last treatment. They will then have visits every 12 weeks. Participants will be followed for up to 15 years. This includes physical exams every year for 5 years.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02649855

    Sponsor: National Cancer Institute (NCI)

    Primary Outcome Measures:

    • Measure: Determine if PROSTVAC combined with docetaxel is able to induce greater antigen spreading (i.e. a broader immune response) with greater associated response score compared to docetaxel alone after 19 weeks.
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Scores from the subset consisting of previously untreated patients on the superior randomized arm will be tested against the patients on the new PROSTVAC then docetaxel cohort (Arm C).
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Patients getting PROSTVAC prior to chemotherapy will be evaluated for antigen specific responses after completing vaccine followed by 6cycles of chemotherapy.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Antigen specific responses for patients getting PROSTVAC prior tochemotherapy.
    • Time Frame: after completing vaccine followed by 6 cycles of chemotherapy
    • Safety Issue:
    • Measure: Evaluate immunologic response among immune subsets (flow cytometry).
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Evaluate antigen-specific immune responses and response scores at39 weeks in both groups and 1 year in both groups.
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Compare antigen-specific immune responses and response scores at19 weeks in the combination arm (docetaxel and PROSTVAC) andcompared to 39 weeks in the sequence arm (docetaxel followedby PROSTVAC) .
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Evaluate radiographic and biochemical time to progression in both groups.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Evaluate proportion of patients with PSA >0.2 ng/ml at 6 and 12 months.
    • Time Frame: at 6 and 12 months
    • Safety Issue:
    • Measure: Evaluate changes in the tumor microenvironment with biopsies preand post (2 cycles of vaccine therapy; alone or combination)when feasible.
    • Time Frame: pre and post 2 cycles of vaccine therapy
    • Safety Issue:
    • Measure: Evaluate Pharmacogenomic studies to evaluate drug metabolism andtransporters.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Evaluate overall survival.
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 74

    Study Start Date: January 19, 2016

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 100 Years
    • Gender: Male

    Inclusion Criteria:

    • Documented histopathological confirmation of prostate cancer-from a CLIA certified laboratory.
    • Patients must have metastatic disease, defined as at least one lesion on bone scan or at least one lesion that are measurable per RECIST 1.1. (Patients who have metastatic disease by these criteria prior to ADT, but then have changes after ADT that diminish the size of these lesions or changes on bone scan are still eligible.)
    • Patients must have a performance status of 0 to 2 according to the ECOG criteria
    • Patients must have adequate bone marrow, hepatic, and renal function with:
    • ANC greater than or equal to 1500/microL, without CSF support
    • Platelets greater than or equal to 100,000/microL
    • AST(SGOT) less than or equal to 2.5 times upper limit of normal (ULN);
    • ALT(SGPT) less than or equal to 2.5 times upper limit of normal (ULN);
    • Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN), OR in patients with Gilbert s syndrome, a total bilirubin less than or equal to 3.0)
    • Serum albumin greater than or equal to 2.8 g/dL
    • Lipase < 2.0 times the upper limit of normal and no radiologic or clinical evidence of pancreatitis
    • Creatinine less than or equal to 1.5 times institutional upper limits of normal OR Creatinine clearance of greater than or equal to 50 ml/min/1.73 m(2) for patients with creatinine levels above institutional normal by 24-hour urine.
    • Willing to travel to the NIH for follow-up visits
    • 18 years of age or older.
    • Able to understand and sign informed consent.
    • May have had up to 24 months of ADT (testosterone suppression therapy in the nonmetastatic setting) and are at least 12 months removed from treatment
    • Men treated or enrolled on this protocol must also agree to use adequate contraception, prior to the study, for the duration of study participation, and 4 months after completion. Sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must also agree to use both a barrier method and a second method of birth control during the course on the study and for 4 months after the last dose of study drug(s). Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
    • Must have started ADT for metastatic disease within 134 days (for Arm A and B) or within 28 days (for Arm C).

    Exclusion Criteria:

    • Immunocompromised status due to:
    • Human immunodeficiency virus (HIV) positivity.
    • Active autoimmune diseases such as Addison s disease, Hashimoto s thyroiditis, systemic lupus erythematosus, Sj(SqrRoot)(Delta)gren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave s disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
    • Other immunodeficiency diseases
    • Chronic administration (defined as daily or every other day for continued use > 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
    • Evidence of rising PSA on ADT
    • Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient s ability to carry out the treatment program.
    • Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to poxviral vaccines (e.g., vaccinia vaccine)
    • Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).
    • History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
    • Previous serious adverse reactions to smallpox vaccination
    • Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
    • Receipt of an investigational agent within 28 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugs.
    • Patients who test positive for HBV or HCV
    • Uncontrolled hypertension (SBP>170/ DBP>105)
    • Patients who have had prior chemotherapy for prostate cancer.
    • The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).
    • The subject has active brain metastases or epidural disease.
    • Patients with greater than or equal to grade 2 peripheral neuropathy at baseline.
    • Patients with history of splenectomy

    Contact:

    • Anna C Couvillon, C.R.N.P.
    • (240) 858-3148

    Location:

    • National Institutes of Health Clinical Center, 9000 Rockville Pike
    • Bethesda Maryland 20892 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • From the Desk of Evan Yu: Another advance in metastatic hormone-sensitive prostate cancer may change standard of care options but not attitude toward clinical trials.

    For the longest time metastatic hormone-sensitive prostate cancer has been treated with androgen deprivation therapy (ADT).  Recently, the CHAARTED1 trial and STAMPEDE,2 both showed a dramatic survival benefit when 6 cycles of docetaxel was added to ADT.  For the CHAARTED trial, subgroup analyses confirmed survival benefit for those patients with high volume disease, defined as ≥4 bone metastases with at least one in the appendicular skeleton and/or a visceral metastasis. 
    Published July 14, 2017
  • Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).

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    Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).


    Condition: Prostatic Neoplasms, Neoplasm Metastasis

    Intervention:

    • Procedure: Radical Prostatectomy (RP)

    Purpose: The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02138721

    Sponsor: University Hospital, Ghent

    Primary Outcome Measures:

    • Measure: Castration Refractory Prostate Cancer Progression-Free Survival
    • Time Frame: up to 10 years
    • Safety Issue:
    • Measure: Time to first Disease Related Event
    • Time Frame: up to 10 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall Survival
    • Time Frame: at year 1 - 2 - 5
    • Safety Issue:
    • Measure: Prostate Cancer Specific Survival
    • Time Frame: at year 1 - 2 - 5
    • Safety Issue:
    • Measure: Quality of Life
    • Time Frame: at month 6 - 12
    • Safety Issue:
    • Measure: Time to Androgen Deprivation Therapy start
    • Time Frame: up to 10 years, estimated to occur within 24 months
    • Safety Issue:

    Estimated Enrollment: 80

    Study Start Date: May 2014

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 85 Years
    • Gender: Male

    Inclusion Criteria:

    • Diagnosis of prostate adenocarcinoma, confirmed by histology
    • Newly diagnosis of metastatic disease (stage TanyNanyM+)
    • Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
    • Written informed consent, male ≥18yo
    • Willing and expected to comply with study protocol and follow-up schedule
    • Multidisciplinary Oncologic Consultation (MOC) approval

    Exclusion Criteria:

    • Previous local or systemic treatment for prostate cancer
    • Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
    • Symptoms clearly related to metastatic lesions
    • Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment

    Contact:

    • Nicolaas Lumen, MD, PhD

    Locations:

    • ASZ Aalst
    • Aalst Belgium
    • Imelda Ziekenhuis
    • Bonheiden Belgium
    • University Hospital, Ghent
    • Ghent 9000 Belgium
    • Sint-Fransiskusziekenhuis
    • Heusden-Zolder Belgium
    • AZ Jan Portaels
    • Vilvoorde Belgium

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay

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    Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay


    Condition: Prostate Cancer

    Intervention:

    • Drug: docetaxel
    • Other: Blood draws

    Purpose: In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel exposure levels, determined as an area under the curve (AUC), will be retrospectively correlated with reports of toxicity, tumor response, quality of life, time to disease progression and overall survival to provide guidance on what the appropriate target range for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel therapy for their disease.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02376296

    Sponsor: Saladax Biomedical, Inc.

    Primary Outcome Measures:

    • Measure: Variability of docetaxel exposure
    • Time Frame: Up to 6 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Docetaxel treatment related toxicities
    • Time Frame: Up to 7 months after the initiation of docetaxel therapy
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Frequency of growth factor usage
    • Time Frame: Up to 7 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Number of days hospitalized for treatment of docetaxel related toxicities
    • Time Frame: Up to 7 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Time to prostate specific antigen (PSA) progression
    • Time Frame: Up to 24 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Tumor response as determined by imaging
    • Time Frame: Up to 7 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Changes in quality of life
    • Time Frame: Up to 6 months after the initiation of docetaxel therapy
    • Safety Issue:
    • Measure: Overall survival
    • Time Frame: Up to 24 months after the initiation of docatexel therapy
    • Safety Issue:

    Estimated Enrollment: 80

    Study Start Date: February 2015

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
    • Male subjects 18 years of age or older.
    • About to start a new line of treatment with docetaxel (75 mg/m2) in combination with prednisone.
    • All subjects must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and good clinical practices (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to the beginning of specific study procedures.
    • Prior surgical castration or concurrent use of an agent for chemical castration with a serum testosterone level < 50 ng/dL.
    • Subjects with hormone naïve metastatic prostate cancer, must have high-volume disease, defined as extra-nodal visceral disease or bone metastases with at least 4 bone lesions (one being outside of the vertebral column or pelvis).
    • Subjects with hormone naïve high-volume metastatic prostate adenocarcinoma must have been on androgen deprivation therapy (including luteinizing hormone-releasing hormone (LHRH) agonist therapy, LHRH antagonist therapy, or surgical castration) for less than 120 days prior to starting docetaxel therapy.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    • For subjects with castrate resistant prostate cancer (CRPC), at least four weeks elapsed between withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and initiation of docetaxel therapy.
    • For subjects with CRPC, at least four weeks elapsed between last administration of Abiraterone (Zytiga®) or Enzalutamide (Xtandi®) and initiation of docetaxel therapy.
    • At least four weeks elapsed between prior surgery or prior radiotherapy and initiation of docetaxel therapy.
    • Radiograph-documented evidence of soft tissue or bony metastatic disease.
    • Must have adequate hematologic, hepatic and renal function as defined below:
    • Hematologic (minimal values): Absolute neutrophil count ≥ 1,500/mm3; Hemoglobin ≥ 10.0 g/dl; Platelet count ≥ 75,000/mm3
    • Hepatic Function: Total Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); asparate transaminase (AST) and alanine transaminase (ALT) < 2 x institutional ULN
    • Suitable venous access and healthy enough (as determined by the treating physician) to provide whole blood sample.

    Exclusion Criteria:

    • Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone or required premedication for the treatment regimen.
    • Serious concurrent disorders (active infection requiring intravenous antibiotics, unstable angina, uncompensated congestive heart failure (CHF), or hepatic failure) that, in the opinion of the investigator, would prevent the use of docetaxel and/or compromise the subject's ability to provide whole blood samples for participation in the study.
    • Concurrent use of any non-FDA approved (i.e. investigational or experimental) anticancer agent(s) or within four (4) weeks of enrolling on the study.
    • Pre-existing neuropathy ≥ grade 2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.
    • Individuals with known seropositivity for human immunodeficiency virus (HIV), hepatitis C virus, hepatitis B surface antigen, or syphilis.
    • Unwilling or unable to follow protocol requirements or to provide informed consent.

    Contact:

    • Craig Miller, BS
    • 484-547-0540

    Locations:

    • UPMC CancerCenter - Beaver
    • Beaver Pennsylvania 15009 United States
    • UPMC CancerCenter - Upper St. Clair
    • Bethel Park Pennsylvania 15102 United States
    • UPMC CancerCenter - Horizon
    • Farrell Pennsylvania 16121 United States
    • Arnold Palmer Cancer Center - Oakbrook
    • Greensburg Pennsylvania 15601 United States
    • Arnold Palmer Cancer Center
    • Greensburg Pennsylvania 15601 United States
    • UPMC CancerCenter - Greenville
    • Greenville Pennsylvania 16125 United States
    • UPMC CancerCenter - Indiana
    • Indiana Pennsylvania 15701 United States
    • UPMC CancerCenter at John P. Murtha Regional Cancer Center
    • Johnstown Pennsylvania 15901 United States
    • UPMC CancerCenter - Mckeesport
    • McKeesport Pennsylvania 15132 United States
    • UPMC CancerCenter - Monroeville
    • Monroeville Pennsylvania 15146 United States
    • Arnold Palmer Medical Oncology - Mount Pleasant
    • Mount Pleasant Pennsylvania 15666 United States
    • UPMC CancerCenter - New Castle
    • New Castle Pennsylvania 16105 United States
    • UPMC CancerCenter - St. Margaret
    • Pittsburgh Pennsylvania 15215 United States
    • UPMC CancerCenter - Hillman Cancer Center
    • Pittsburgh Pennsylvania 15232 United States
    • UPMC CancerCenter - Passavant HOA
    • Pittsburgh Pennsylvania 15237 United States
    • UPMC CancerCenter - Passavant OHA
    • Pittsburgh Pennsylvania 15237 United States
    • UPMC CancerCenter - Northwest
    • Seneca Pennsylvania 16346 United States
    • UPMC CancerCenter - Uniontown
    • Uniontown Pennsylvania 15401 United States
    • UPMC CancerCenter - Washington
    • Washington Pennsylvania 15301 United States
    • UPMC CancerCenter - Jefferson
    • West Mifflin Pennsylvania 15122 United States

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Phase II Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH)

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    Phase II Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH)


    Condition: Prostate Cancer Metastatic

    Intervention:

    • Drug: Rucaparib

    Purpose: The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer. Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03413995

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Primary Outcome Measures:

    • Measure: Response Rate(PSA)to rucaparib for pts with met. hormone sensitive prostate ca harboring germline mutation in homologous recombination DNA repair gene. Measured by decline in PSA to 50% of baseline, confirmed w/second measurement at least 4 weeks apart.
    • Time Frame: 4 weeks
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: PSA progression-free survival, defined as a time from initiation of rucaparib therapy until PSA increase of 25 %, confirmed with another measurement at least 3 weeks later
    • Time Frame: 6 months
    • Safety Issue:
    • Measure: Progression-free survival, defined as time from initiation of rucaparib therapy to radiographic or clinical progression or death, whichever comes first.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Objective response rate, defined as the proportion of patients achieving a complete or partial response in target lesions found on radiographic scans
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: September 10, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
    • Males aged 18 years of age and above
    • Histological or cytologic proof of adenocarcinoma of the prostate
    • Germline mutation in one or more homologous recombination DNA-repair genes (BRCA1, BRCA2, ATM, CHEK2, NBN, RAD50, RAD51C, RAD51D, PALB2, MRE11, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM) as documented by a clinical CLIA-grade, genetic test (including but not limited to Invitae, Color Genomics, etc)
    • All patients must be ineligible for or have declined androgen deprivation therapy (ADT)-based systemic treatment
    • Absolute PSA ≥2.0 ng/ml at screening.
    • Radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 8 weeks.
    • Serum testosterone ≥ 100 ng/dl.
    • Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
    • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT))
    • Participants must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
    • Estimated creatinine clearance = (140-age [years]) x weight (kg) serum creatinine (mg/dL) x 72
    • ECOG Performance Status <2
    • Participants must have a life expectancy ≥ 12 months.
    • Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination [see appendix E for acceptable methods], throughout the period of taking study treatment and for 6 months after last dose of study drug to prevent pregnancy in a partner.

    Exclusion Criteria:

    • Current active second malignancy (history of non-melanoma skin cancers and superficial bladder cancers are allowed)
    • Prior ADT in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary is allowed; prior ADT for biochemical recurrence is also allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (>100 ng/dl). The total duration of prior ADT should not exceed 24 months.
    • Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) in the past 6 months is not permitted. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
    • Presence of visceral (i.e. lung or liver) metastases >3cm in long-axis dimension.
    • Pain due to bone metastases requiring narcotic analgesics.
    • Prior treatment with intravenous chemotherapy.
    • Use of any prohibited concomitant medications (Appendix B: Medications With the Potential for Drug-Drug Interactions) within the prior 2 weeks.
    • Involvement in the planning and/or conduct of the study (applies to both Clovis Oncology staff and/or staff at the study site)
    • Previous enrollment in the present study
    • Participation in another clinical study with an investigational product during the last 1 month.
    • Any previous treatment with a PARP inhibitor, including rucaparib.
    • Resting ECG with QTc > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
    • Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
    • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
    • Major surgery within 2 weeks of starting study treatment, and patients must have recovered from any effects of any major surgery.
    • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.
    • Unable to swallow orally administered medication or gastrointestinal disorders likely to interfere with absorption of the study medication.
    • Immunocompromised patients, e.g., patients who are known to be serologically positive for HIV. Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
    • Known hypersensitivity to rucaparib or any of the excipients of the product.
    • Whole blood transfusions in the last 30 days prior to entry to the study.

    Contact:

    • Mark Markowski, MD
    • 410-614-0567

    Location:

    • Johns Hopkins Hospital
    • Baltimore Maryland 21205 United States

    View trial on ClinicalTrials.gov


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    Published November 3, 2018
  • Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)

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    Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)


    Condition: Prostate Cancer

    Intervention:

    • Other: Standard of Care

    Purpose: Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of three years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment, every three months for the first and second year then every six months. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT03151629

    Sponsor: Prostate Cancer Clinical Trials Consortium

    Primary Outcome Measures:

    • Measure: Practice Patterns
    • Time Frame: 5 years
    • Safety Issue:

    Estimated Enrollment: 5000

    Study Start Date: May 1, 2017

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    Eligibility:

    • Age: minimum 21 Years maximum N/A
    • Gender: Male

    Criteria: • Willing and able to provide written informed consent and privacy authorization for the release of personal health information. NOTE: Privacy authorization may be either included in the informed consent or obtained separately. - Males 21 years of age and above - Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA >20ng/mL - No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin

    Contact:

    • Jacob Vinson
    • 646-888-0421

    Locations:

    • University of Alabama-Birmingham
    • Birmingham Alabama 35233 United States
    • University of California - Los Angeles
    • Los Angeles California 90024 United States
    • University of California San Diego
    • San Diego California 92037 United States
    • Emory Winship Cancer Institute
    • Atlanta Georgia 30322 United States
    • University of Illinois at Chicago
    • Chicago Illinois 60607 United States
    • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    • Chicago Illinois 60611 United States
    • University of Chicago
    • Chicago Illinois 60637 United States
    • Tulane University
    • New Orleans Louisiana 70112 United States
    • Tulane University
    • New Orleans Louisiana 70118 United States
    • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Baltimore Maryland 21231 United States
    • Chesapeake Urology Associates
    • Towson Maryland 21204 United States
    • Dana-Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • University of Michigan
    • Ann Arbor Michigan 48109 United States
    • Karmanos Cancer Institute
    • Detroit Michigan 48201 United States
    • Roswell Park Comprehensive Cancer Center
    • Buffalo New York 14203 United States
    • Columbia University Medical Center
    • New York New York 10032 United States
    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States
    • Weill Cornell Medical Center
    • New York New York 10065 United States
    • University of North Carolina at Chapel Hill
    • Chapel Hill North Carolina 27514 United States
    • Duke University
    • Durham North Carolina 27710 United States
    • Oregon Health & Science University Hospital
    • Portland Oregon 97239 United States
    • Thomas Jefferson University
    • Philadelphia Pennsylvania 19107 United States
    • Baylor College of Medicine
    • Houston Texas 77030 United States
    • University of Virginia
    • Charlottesville Virginia 22903 United States
    • University of Washington Medical Center
    • Seattle Washington 98195 United States
    • University of Wisconsin Carbone Cancer Center
    • Madison Wisconsin 53705 United States
    • St. Vincent's Hospital Sydney
    • Darlinghurst New South Wales Australia
    • Macquarie University
    • Sydney New South Wales Australia
    • Westmead Hospital
    • Sydney New South Wales Australia
    • Redland Hospital
    • Cleveland Queensland Australia
    • Princess Alexandra Hospital
    • Woolloongabba Queensland Australia
    • Eastern Health (Box Hill Hospital)
    • Box Hill Victoria Australia
    • Australian Prostate Centre
    • Melbourne N. Australia
    • Australian Urology Associates
    • Melbourne Australia
    • Hospital Beneficência Portuguesa
    • Bela Vista São Paulo Brazil
    • Instituto do Câncer e Transplante
    • Curitiba Brazil
    • Centro de Pesquisa em Oncologia
    • Porto Alegre Brazil
    • Centro Paulista de Oncologia
    • São Paulo Brazil
    • BC Cancer Agency
    • Vancouver British Columbia Canada
    • Juravinski Cancer Centre
    • Hamilton Ontario Canada
    • Ottawa Hospital Cancer Centre
    • Ottawa Ontario Canada
    • Centre hospitalier de l'Université de Montréal (CHUM)
    • Montréal Quebec Canada
    • CHU de Québec-Université Laval
    • Québec Quebec Canada
    • Beacon Hospital
    • Dublin Leinster Ireland
    • St. Vincent's University Hospital
    • Dublin Ireland
    • Vall d'Hebron Institute of Oncology
    • Barcelona Catalunya Spain
    • Hospital Clínic de Barcelona
    • Barcelona Spain
    • Hospital Clinico San Carlos
    • Madrid Spain
    • Hospital Universitario 12 de Octubre
    • Madrid Spain
    • Hospital Universitario Virgen de la Victoria
    • Málaga Spain
    • Skane University Hospital
    • Malmö Skane Sweden
    • Orebro University Hospital
    • Örebro Sweden
    • Kantonsspital Graubünden
    • Chur Switzerland
    • Kantonsspital St. Gallen
    • Saint Gallen Switzerland
    • Universitätsspital Zürich
    • Zürich Switzerland
    • University Hospital Southampton NHS Foundation Trust
    • Southampton Hampshire United Kingdom
    • Guys St Thomas NHS Foundation Trust
    • London United Kingdom
    • The Royal Marsden NHS Foundation Trust
    • London United Kingdom
    • The Christie NHS Foundation Trust
    • Manchester United Kingdom

    View trial on ClinicalTrials.gov


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    Published October 16, 2017
  • Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

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    Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET


    Condition: Prostatic Neoplasms

    Intervention:

    • Drug: Enzalutamide
    • Drug: NSAA
    • Drug: LHRHA or Surgical Castration

    Purpose: The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02446405

    Sponsor: University of Sydney

    Primary Outcome Measures:

    • Measure: Overall Survival Time
    • Time Frame: 3 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Prostate specific antigen progression free survival time
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: Clinical progression free survival time
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: Adverse events
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: Health-related quality of life (EORTC Core Quality of Life Questionnaire (QLQ C-30), Quality of Life Questionnaire for Prostate Cancer (PR-25), Euroqol 5 item preference-based measure of health (EQ-5 D-5L))
    • Time Frame: 3 years
    • Safety Issue:
    • Measure: Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)
    • Time Frame: 3 years
    • Safety Issue:

    Estimated Enrollment: 1125

    Study Start Date: March 2014

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Male aged 18 or older with metastatic adenocarcinoma of the prostate
    2. Target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
    3. Adequate bone marrow function: Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L.
    4. Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN) and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5 x ULN
    5. Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-
    7. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer.
    8. Study treatment both planned and able to start within 7 days after randomisation.
    9. Willing and able to comply with all study requirements, including treatment and required assessments
    10. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision
    11. Signed, written, informed consent

    Exclusion Criteria:

    • 1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components 2. History of
    • seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
    • loss of consciousness or transient ischemic attack within 12 months of randomization
    • significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 3. Life expectancy of less than 12 months. 4. History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours). 5. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide. 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse; 7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception. 8. Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:
    • Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration.
    • In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg. 9. Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted. 10. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.

    Locations:

    • Dana Farber Cancer Institute
    • Boston Massachusetts 02115 United States
    • Chris O'Brien Lifehouse
    • Camperdown New South Wales 2050 Australia
    • Coffs Harbour Health Campus
    • Coffs Harbour New South Wales 2450 Australia
    • Concord Cancer Centre - Concord Repatriation General Hospital
    • Concord New South Wales 2139 Australia
    • St Vincent's Hospital Sydney
    • Darlinghurst New South Wales 2010 Australia
    • Nepean Cancer Care Centre
    • Kingswood New South Wales 2747 Australia
    • St. George Hospital
    • Kogarah New South Wales 2217 Australia
    • Central West Cancer Services
    • Orange New South Wales 2800 Australia
    • Port Macquarie Base Hospital
    • Port Macquarie New South Wales 2444 Australia
    • Prince of Wales Hospital
    • Randwick New South Wales 2031 Australia
    • Northern Cancer Institute
    • St Leonards New South Wales 2065 Australia
    • Tamworth Rural Referral Hospital
    • Tamworth New South Wales 2340 Australia
    • The Tweed Hospital
    • Tweed Heads New South Wales 2485 Australia
    • Riverina Cancer Care Centre
    • Wagga Wagga New South Wales 2650 Australia
    • Sydney Adventist Hospital
    • Wahroonga New South Wales 2076 Australia
    • Wollongong Hospital
    • Wollongong New South Wales 2500 Australia
    • Royal Darwin Hospital
    • Tiwi Northern Territory 0810 Australia
    • Townsville Hospital
    • Douglas Queensland 4814 Australia
    • Royal Brisbane and Women's Hospital
    • Herston Queensland 4006 Australia
    • Nambour General Hospital
    • Nambour Queensland 4560 Australia
    • Gold Coast University Hospital
    • Southport Queensland 4215 Australia
    • Princess Alexandra Hospital
    • Woolloongabba Queensland 4102 Australia
    • Royal Adelaide Hospital
    • Adelaide South Australia 5000 Australia
    • Flinders Medical Centre
    • Bedford Park South Australia 5042 Australia
    • Adelaide Cancer Centre - Ashford Cancer Care Centre
    • Kurralta Park South Australia 5037 Australia
    • Royal Hobart Hospital
    • Hobart Tasmania 7000 Australia
    • Bendigo Hospital
    • Bendigo Victoria Australia
    • Monash Cancer Centre Moorabbin
    • Bentleigh East Victoria 3165 Australia
    • Peter MacCallum Cancer Centre - East Melbourne
    • East Melbourne Victoria 3002 Australia
    • St. Vincents Hospital Melbourne
    • Fitzroy Victoria 3065 Australia
    • Peninsula South Eastern Haematology & Oncology Group- Peninsula Oncology Centre
    • Frankston Victoria 3199 Australia
    • University Hospital Geelong
    • Geelong Victoria 3220 Australia
    • Austin Hospital
    • Heidelberg Victoria 3084 Australia
    • Australian Urology Associates
    • Malvern Victoria 3144 Australia
    • Eastern Health Box Hill Hospital
    • Melbourne Victoria Australia
    • Goulburn Valley Health
    • Shepparton Victoria 3630 Australia
    • Border Medical Oncology
    • Wodonga Victoria 3690 Australia
    • Sir Charles Gairdner Hospital
    • Nedlands Western Australia 6009 Australia
    • Fiona Stanley Hospital (formerly Royal Perth Hospital)
    • Perth Western Australia 6000 Australia
    • Prostate Cancer Institute - Southern Alberta Institute of Urology
    • Calgary Alberta T2V 1P9 Canada
    • Cross Cancer Institute
    • Edmonton Alberta AB T6G 1Z2 Canada
    • BCCA - Fraser Valley Cancer Center
    • Surrey British Columbia BC V3V 1Z2 Canada
    • BCCA Vancouver Centre
    • Vancouver British Columbia V5Z 4E6 Canada
    • CancerCare Manitoba
    • Winnipeg Manitoba Canada
    • Horizon Health Network - Dr Everett Chalmers Hospital
    • Fredericton New Brunswick NB E3B 5N5 Canada
    • Saint John Regional Hospital
    • Saint John New Brunswick NB E2L 4L4 Canada
    • QEII Health Sciences Centre, Capital District Health Authority
    • Halifax Nova Scotia NS B3H 2Y9 Canada
    • Cambridge Memorial Hospital
    • Cambridge Ontario ON N1R 7S6 Canada
    • Juravinski Cancer Centre
    • Hamilton Ontario L8V 5C2 Canada
    • Cancer Centre of Southeastern Ontario at Kingston General Hospital
    • Kingston Ontario ON K7L 5P9 Canada
    • London Regional Cancer Program
    • London Ontario N6A 5W9 Canada
    • Lakeridge Health Oshawa
    • Oshawa Ontario ON L1G 2B9 Canada
    • Ottawa Hospital Cancer Centre
    • Ottawa Ontario ON K1H 8L6 Canada
    • Algoma District Cancer Program Sault Area Hospital
    • Sault Ste. Marie Ontario P6B 0A8 Canada
    • Thunder Bay Regional Health Sciences Centre
    • Thunder Bay Ontario ON P7B 6V4 Canada
    • University Health Network - Princess Margaret Hospital
    • Toronto Ontario ON M5G 2M9 Canada
    • Hôpital Notre-Dame
    • Montreal Quebec H2L 4M1 Canada
    • CHUQ-Pavillon Hotel-Dieu de Quebec
    • Québec City Quebec QC G1R 2J6 Canada
    • Allan Blair Cancer Centre
    • Regina Saskatchewan S4T 7T1 Canada
    • Saskatoon Cancer Centre
    • Saskatoon Saskatchewan S7N 4H4 Canada
    • Beaumont Hospital
    • Beaumont Dublin Dublin 9 Ireland
    • Beacon Private Hospital
    • Dublin Dublin 18 Ireland
    • Mater Misercordiae University Hospital
    • Dublin Dublin 7 Ireland
    • Mater Private Hospital
    • Dublin Dublin 7 Ireland
    • St James Hospital
    • Dublin Dublin 8 Ireland
    • St Vincent's University Hospital
    • Elm Park Dublin 4 Ireland
    • Galway University Hospital
    • Galway Ireland
    • Adelaide and Meath Hospital - National Children's Hospital
    • Tallaght Dublin 24 Ireland
    • University Hospital Waterford
    • Waterford Ireland
    • Auckland City Hospital
    • Auckland New Zealand
    • Christchurch Hospital
    • Christchurch 8140 New Zealand
    • Waikato Hospital
    • Hamilton 3204 New Zealand
    • Royal Cornwall Hospital
    • Truro Cornwall TR1 3LQ United Kingdom
    • Royal Sussex Hospital
    • Brighton East Sussex BN2 5BE United Kingdom
    • Kent and Canterbury Hospital
    • Canterbury Kent CT1 3NG United Kingdom
    • Aberdeen Royal Infirmary
    • Aberdeen Scotland AB25 2ZN United Kingdom
    • Velindre Cancer Centre
    • South Glamorgan Wales CF14 2TL United Kingdom
    • University College Hospital London
    • London NW1 2BU United Kingdom
    • Guys and St Thomas Hospital
    • London SE1 9RT United Kingdom
    • Royal Marsden Hospital
    • London SW3 6JJ United Kingdom
    • University Hospital Southampton
    • Southampton SO16 6YD United Kingdom
    • Great Western Hospital
    • Swindon SN3 6BB United Kingdom

    View trial on ClinicalTrials.gov


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    Published July 12, 2017
  • Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer

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    Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer


    Condition: Hormone Sensitive Oligometastatic Prostate Cancer

    Intervention:

    • Procedure: Radical prostatectomy
    • Radiation: HDR (19Gy) or SBRT (35-40Gy)

    Purpose: Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03301701

    Sponsor: Dr. Patrick Cheung

    Primary Outcome Measures:

    • Measure: Patients willing to accept their randomization
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Toxicity
    • Time Frame: 7 years
    • Safety Issue:
    • Measure: Efficacy
    • Time Frame: 7 years
    • Safety Issue:
    • Measure: Efficacy
    • Time Frame: 7 years
    • Safety Issue:
    • Measure: Efficacy
    • Time Frame: 7 years
    • Safety Issue:
    • Measure: Efficacy
    • Time Frame: 7 years
    • Safety Issue:
    • Measure: Efficacy
    • Time Frame: 7 years
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: September 22, 2017

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Able to provide informed consent.
    • Histologic confirmation of prostate adenocarcinoma.
    • Stage IV disease with ≤ 5 metastases outside of the pelvis.
    • ≤ 3 metastases in any one organ system.
    • ECOG performance 0-1.
    • All metastatic tumours amenable to SBRT.
    • Patient eligible for either RP or RT to the prostate.

    Exclusion Criteria:

    • Castration resistant prostate cancer.
    • Previous RP or RT to prostate.
    • Inability to treat all metastases with SBRT.
    • Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.

    Contact:

    • Merrylee McGuffin
    • 416-480-5000 Ext. 6104

    Location:

    • Sunnybrook Health Sciences Centre
    • Toronto Ontario M4N3M5 Canada

    View trial on ClinicalTrials.gov


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    Published October 16, 2017
  • Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination With Intermittent Androgen Deprivation Therapy in Men With Hormone-Sensitive Prostate Cancer

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    Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination With Intermittent Androgen Deprivation Therapy in Men With Hormone-Sensitive Prostate Cancer


    Condition: Prostate Cancer, Adenocarcinoma of the Prostate

    Intervention:

    • Drug: Nivolumab
    • Drug: Degarelix
    • Drug: BMS-986253

    Purpose: MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-sepcific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back. The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03689699

    Sponsor: Charles G. Drake

    Primary Outcome Measures:

    • Measure: Rate of PSA recurrence
    • Time Frame: Up to 10 months after completion of therapy
    • Safety Issue:
    • Measure: Number of adverse events
    • Time Frame: Up to two years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Percentage change in PSA
    • Time Frame: Baseline, 8 weeks
    • Safety Issue:
    • Measure: Relapse-free survival (RFS)
    • Time Frame: Up to two years
    • Safety Issue:

    Estimated Enrollment: 60

    Study Start Date: October 11, 2018

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 99 Years
    • Gender: Male

    Inclusion Criteria:

    • Age ≥18 years.
    • Histologically confirmed adenocarcinoma of the prostate.
    • Previously undergone primary therapy for prostate cancer (radical prostatectomy (RP) or external beam radiation (XRT) or RP + XRT). Salvage XRT following RP ≥ 6 months prior to registration is allowed.
    • Rising PSA (two consecutive values ≥2.0 ng/mL above the PSA nadir taken ≥3 weeks apart). PSA level of 2-25 ng/mL (PSA up to 50 is allowed for patients undergoing pre- and on-treatment biopsies).
    • For the biopsy sub-groups, subjects must be willing to undergo pre- and on-treatment biopsies.
    • PSA Doubling Time (PSADT) ≤12 months
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky score ≥70.
    • Adequate bone marrow, hepatic, and renal function.
    • Willingness to use barrier contraception during treatment.
    • Willingness to provide written informed consent and HIPAA authorization.

    Exclusion Criteria:

    • Received any experimental immunotherapy on an experimental clinical trial ≤ 1 year prior to registration.
    • PSA > 25 at time of enrollment (or PSA >50 for patients receiving pre- and on-treatment biopsies).
    • Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
    • Received salvage XRT ≤ 6 months prior to registration
    • Received ADT ≤ 6 months prior to registration
    • Received any form of chemotherapy ≤ 90 days prior to registration
    • Received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor (GM-CSF) ≤ 90 days prior to registration
    • Any major surgery requiring general anesthesia ≤ 28 days prior to registration.
    • Any other concurrent or prior treatment for prostate cancer ≤ 28 days prior to registration.
    • An active infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5 F or 38.1 C) within 1 week prior to registration.
    • Prior systemic, ongoing immunosuppressive therapy ≤ 14 days prior to study treatment administration (except for adrenal replacement steroid doses ≤ 10mg daily prednisone equivalent in the absence of active autoimmune disease or a short course of steroids (<5 days) up to 7 days prior to initiating study treatment).
    • Prior use of experimental agents for prostate cancer
    • Prior participation in an anti-interleukin 8 (IL8) clinical study
    • A candidate is scheduled or likely to be scheduled for salvage external beam XRT or surgery for prostate cancer during the study period
    • Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors (prior use of these agents is allowed if ≥3 months prior to registration).
    • History of known or suspected autoimmune disease with the following exceptions:
    • Asthma and/or allergic rhinitis (seasonal allergies)
    • Vitiligo
    • Resolved childhood atopic dermatitis
    • Psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
    • Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement
    • Euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin (Ig) prior to the first dose of study treatment).
    • Type 1 diabetes mellitus
    • History of malignancy within the last 2 years (except non-melanoma skin cancers and superficial bladder cancer) and for which no additional therapy is required or anticipated to be required during the study period.
    • Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
    • Known prior or current history of HIV and/or hepatitis B/C
    • Prior organ allograft

    Contact:

    • Lisa Olmos
    • 212.342.5162

    Locations:

    • Weill Cornell Medical Center
    • New York New York 10021 United States
    • Columbia University Medical Center
    • New York New York 10032 United States
    • Sidney Kimmel Cancer Center- Thomas Jefferson University
    • Philadelphia Pennsylvania 19107 United States

    View trial on ClinicalTrials.gov


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    Published March 24, 2019
  • Randomized Phase II Screening Trial of Enzalutamide/MDV-3100 and LHRH Analogue vs Combined Androgen Deprivation (LHRH Analogue + Bicalutamide) in Metastatic Hormone Sensitive Prostate Cancer

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    Randomized Phase II Screening Trial of Enzalutamide/MDV-3100 and LHRH Analogue vs Combined Androgen Deprivation (LHRH Analogue + Bicalutamide) in Metastatic Hormone Sensitive Prostate Cancer


    Condition: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

    Intervention:

    • Drug: enzalutamide
    • Drug: bicalutamide
    • Procedure: orchiectomy
    • Drug: leuprolide acetate
    • Drug: goserelin acetate
    • Other: laboratory biomarker analysis

    Purpose: This randomized phase II trial studies if enzalutamide added to standard luteinizing hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies stop the body from producing or block the effect of male sex hormones (testosterone). Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of prostate cancer. Hormonal therapies that lower the level of testosterone are among the most effective treatments for prostate cancer that have spread to other areas of the body (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02058706

    Sponsor: Barbara Ann Karmanos Cancer Institute

    Primary Outcome Measures:

    • Measure: Achievement of PSA remission assessed using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria
    • Time Frame: Month 7
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Achievement of measurable disease assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Achievement of PSA response assessed using PCWG2 criteria
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Duration of RD
    • Time Frame: From the time measurement criteria are met for complete response/partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
    • Safety Issue:
    • Measure: Duration of SDD
    • Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 2 years
    • Safety Issue:
    • Measure: TTF
    • Time Frame: From date of registration to date of progressive disease or date patient is taken off study for any reason, assessed up to 2 years
    • Safety Issue:
    • Measure: TTP
    • Time Frame: From date of registration to date of progressive disease defined as either progression of measurable disease by RECIST criteria, progression of bone metastases, or occurrence of new SRE, assessed up to 2 years
    • Safety Issue:
    • Measure: TTP in patients with bone metastases
    • Time Frame: From date of registration to date of progressive disease defined as either the appearance of a minimum of 2 new lesions on bone scan which are related to metastatic disease or the occurrence of a new SRE, assessed up to 2 years
    • Safety Issue:
    • Measure: PFS
    • Time Frame: From registration to PSA progression defined by PCWG II criteria or measurable disease by RECIST 1.1, assessed up to 2 years
    • Safety Issue:
    • Measure: OS
    • Time Frame: From date of registration to death or last follow up, assessed up to 2 years
    • Safety Issue:
    • Measure: Occurrence rate of toxicity, graded per the Common Terminology Criteria for Adverse Events 4.0
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Occurrence rate of SRE
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Distribution of time until SRE
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Occurrence rate of CTC response
    • Time Frame: Up to month 1
    • Safety Issue:

    Estimated Enrollment: 92

    Study Start Date: May 2014

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed prostate adenocarcinoma with metastasis either starting or recently started on LHRH analogue therapy. [Late induction permitted within 3 months of starting LHRH analogue therapy or antiandrogen]
    • All patients who have not initiated hormone therapy (Early induction patients) must have elevated PSA ≥ 4 ng/ml within 28 days prior to registration. For late induction registrations, PSA must be ≥ 4 ng/ml prior to start of androgen deprivation therapy; either antiandrogen or LHRH analogue or GNRH antagonist .If patients are on antiandrogen, this will need to be discontinued for at least 7 days prior to registration.
    • Patients with a history of prior neoadjuvant or adjuvant hormone therapy are eligible provided they have received twenty four or less months of hormone treatment (single or combination treatment, excluding orchiectomy). Both therapies (neoadjuvant/adjuvant hormone therapy) must have been discontinued at least 6 months prior to registration. This is intended to exclude patients who might have been rendered indirectly androgen insensitive.
    • There must be no plans to receive concomitant chemotherapy, biological response modifiers, radiation therapy or hormonal therapy. Concomitant radiation therapy is allowed for the palliation of severe pain/neuropathic compression. Prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed.
    • Patients must have a performance status of 0
    • 2 by Zubrod Criteria.
    • Patients must have recovered from any major infections and/or surgical procedures and,in the opinion of the investigator, not have significant active medical illness precluding protocol treatment or survival.
    • No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, superficial or in situ cancer of the bladder. For an invasive cancer the patients should be disease free for at least 3 years prior to enrollment on study.
    • For all patients a bone scan must be performed within 60 days prior to registration for tumor assessment. CT scans (abdomen and pelvis) and chest x-ray are optional, but must be repeated if used for disease assessment. For late induction registrations, tumor assessment imaging showing metastatic disease must be available prior to start of androgen deprivation therapy.
    • Age 18 or older and willing and able to provide informed consent.
    • Willingness to swallow pills and no medical condition that would interfere with this.
    • Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Patients are also required to use a condom if having sex with a pregnant woman.
    • Patient should agree to a tumor tissue biopsy prior to protocol enrollment. Post therapy biopsy is optional.
    • Patients who are being treated with a GNRH antagonist should be willing to switch to a LHRH analogue after registration.
    • Patients must have one of the following a) Low volume disease (defined as no visceral metastases and < 4 bone metastases) or b) are not candidates for docetaxel based chemotherapy or 3) refused docetaxel chemotherapy

    Exclusion Criteria:

    • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit;
    • Known or suspected brain metastasis or active leptomeningeal disease;
    • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
    • Absolute neutrophil count < 1,000/μL, or platelet count < 50,000/μL, or hemoglobin<8 g/dL) at the Screening visit.
    • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal
    • Creatinine > 177 μmol/L (2 mg/dL)
    • Clinically significant cardiovascular disease including: Myocardial infarction within 6 months; Uncontrolled angina within 3 months; Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure (NYHA) class 3 or 4 in the past, unless screening echocardiogram or multi-gated acquistion scan performed within 3 months results in a left ventricular ejection fraction that is greater or equal to 45%; History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes); History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit; Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG; Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg
    • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
    • Treatment with concurrent 5-α reductase inhibitors (finasteride, dutasteride), estrogens, and/or cyproterone
    • Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment (Day 1 visit);
    • History of prostate cancer progression on ketoconazole;
    • Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or agents that block the androgen receptor (e.g.,ARN-509)
    • Previous enzalutamide therapy;
    • Use of an investigational agent within 2 weeks of enrollment (Day 1 visit);
    • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of replacement steroids or > equivalent of 10 mg of prednisone perday within 4 weeks of enrollment (Day 1 visit);
    • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
    • Prior chemotherapy for metastatic disease.
    • >30 days of antiandrogen therapy monotherapy without androgen deprivation therapy.
    • Life expectancy of 6 months or less.

    Locations:

    • University of Alabama at Birmingham
    • Birmingham Alabama 35294 United States
    • Barbara Ann Karmanos Cancer Institute
    • Detroit Michigan 48201 United States
    • Henry Ford Hospital
    • Detroit Michigan 48202 United States
    • Ohio State University Medical Center
    • Columbus Ohio 43210 United States

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Retrospective Study to Evaluate Time to Event and Healthcare Resource Utilisation of Prostate Cancer Patients Throughout the Disease Stages, From m0HSPC, m1HSPC, m0CRPC, m1CRPC Until Progression or Death

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    Retrospective Study to Evaluate Time to Event and Healthcare Resource Utilisation of Prostate Cancer Patients Throughout the Disease Stages, From m0HSPC, m1HSPC, m0CRPC, m1CRPC Until Progression or Death


    Condition: Prostate Cancer

    Intervention:

    • Other: No intervention

    Purpose: Primary objective of this study is to describe the time in each prostate cancer stage from non-metastatic Hormone Sensitive Prostate Cancer (m0HSPC), metastatic Hormone Sensitive Prostate Cancer (m1HSPC), non-metastatic Castrate-Resistant Prostate Cancer (m0CRPC), metastatic Castrate-Resistant Prostate Cancer (m1CRPC) to progression or death. The secondary objectives of this study are to describe co-medication at each disease stage, to describe co-morbidities at each disease stage and to describe the healthcare resource use and costs associated to each disease stage.

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT03619980

    Sponsor: Astellas Pharma Europe Ltd.

    Primary Outcome Measures:

    • Measure: Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Measure: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Time from entry to exit either by progression or death from prostate cancer stage m0CRPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
    • Time Frame: 11 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Co-morbidities at disease stage m0HSPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-morbidities at disease stage m1HSPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-morbidities at disease stage m0CRPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-morbidities at disease stage m1CRPC
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-medications at disease stage m0HSPC as recorded in the registries
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-medications at disease stage m1HSPC as recorded in the registries
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-medications at disease stage m0CRPC as recorded in the registries
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Co-medications at disease stage m1CRPC as recorded in the registries
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by number of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by number of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by number of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by number of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of prostate cancer treatment regimens
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization in-patient
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization in-patient
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization in-patient
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization in-patient
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization frequency
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization frequency
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization frequency
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization frequency
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization duration
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization duration
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization duration
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization duration
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of hospital visits
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of imaging examinations
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:
    • Measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of laboratory tests
    • Time Frame: 11 years
    • Safety Issue:

    Estimated Enrollment: 1869

    Study Start Date: September 13, 2018

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    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • All patients registered in PPC.

    Exclusion Criteria:

      Location:

      • Site SE46001
      • Uppsala 753 09 Sweden

      View trial on ClinicalTrials.gov


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      Published March 24, 2019
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