Prostate Cancer

{{header-clinical-trials-navigation}}

Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer


Condition: Recurrent Prostate Carcinoma

Intervention:

  • Radiation: High-Dose Rate Brachytherapy
  • Procedure: Hyperthermia Treatment

Purpose: This phase I trial studies the side effects and best way to give hyperthermia and high dose rate radiation therapy in treating patients with prostate cancer that has come back after prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia therapy may make tumor cells more sensitive to the effects of radiation therapy by heating them to several degrees above normal body temperature. Giving hyperthermia and high dose rate radiation therapy may work better in treating patients with recurrent prostate cancer after radiation.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02899221

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Primary Outcome Measures:

  • Measure: Incidence of dose limiting toxicity defined as >= grade 3 per National Cancer Institute Common Toxicity Criteria version 4 occurring within 90 days of treatment and at least possibly attributed to radiation therapy and/or hyperthermia
  • Time Frame: Up to 90 days after last treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of long-term toxicity associated with combined salvage high dose rate brachytherapy and interstitial hyperthermia
  • Time Frame: Up to 5 years after last treatment
  • Safety Issue:
  • Measure: Efficacy of combined salvage high dose rate brachytherapy and interstitial hyperthermia as defined by nadir PSA(prostate-specific antigen) =< 0.5 mg/ml and freedom from biochemical failure per the Phoenix definition (nadir + 2)
  • Time Frame: Up to 5 years after last treatment
  • Safety Issue:

Estimated Enrollment: 10

Study Start Date: March 21, 2017

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Karnofsky performance status > 70%
  • Expected survival of at least 3 years
  • Informed consent signed by the subject
  • Prostate-specific antigen (PSA) blood test within 60 days prior to registration
  • Prostate biopsy with Gleason score and TNM staging within one year prior to registration
  • No evidence of metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration.
  • No evidence of metastasis on bone scan within 120 days prior to registration
  • Within 60 days prior to registration, hematologic minimal values: absolute neutrophil count > 1,500/mm^3
  • Within 60 days prior to registration, hematologic minimal values: hemoglobin > 8.0 g/dl
  • Within 60 days prior to registration, hematologic minimal values: platelet count > 100,000/mm^3
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after completion of treatment
  • Histologically proven persistent or recurrent adenocarcinoma of the prostate following prior external beam radiation therapy or brachytherapy
  • Prior Androgen Deprivation or chemotherapy is allowed if discontinued at least 30 days prior to enrollment
  • Concurrent disease
  • patients under treatment for concurrent medical conditions will be eligible for protocol treatment if, in the opinion of the physician responsible for hyperthermia treatment that the concurrent medical condition will neither interfere with the process of the treatment or patient assessments nor add significantly to the risks or complications of the treatment

Exclusion Criteria:

  • History of urological surgery or procedures predisposing to genitourinary (GU) complications after radiation, i.e., anastomoses, stricture repair, transurethral resection, etc. (will be determined by radiation oncologist)
  • Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound [HIFU] or cryoablation)
  • Documented distant metastatic disease
  • Patient with other co-morbidities that in the opinion of the treating physician would be a contra-indication to protocol participation (e.g. inflammatory bowel disease)
  • Mental incompetence or criminal incarceration

Contact:

  • Mark Hurwitz, MD
  • 215-955-6644

Location:

  • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Philadelphia Pennsylvania 19107 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone


Condition: Prostate Cancer Metastatic to Bone

Intervention:

  • Drug: Radium Ra 223 Dichloride
  • Radiation: Radiation

Purpose: This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve men with oligometastatic prostate cancer to the bone. The study will test if treating the primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT historic cohort.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03304418

Sponsor: University of Utah

Primary Outcome Measures:

  • Measure: Time to Androgen Deprivation Therapy (ADT) Use
  • Time Frame: 15 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time from start of study therapy to start of ADT.
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Evaluate health related quality of life (QOL)
  • Time Frame: This questionnaire will be given every 3 months for 2 years
  • Safety Issue:
  • Measure: Evaluate changes in general function and well being
  • Time Frame: This questionnaire will be given every 3 months for 2 years
  • Safety Issue:
  • Measure: Evaluate time to first skeletal related event (SRE)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Evaluate the PSA doubling time
  • Time Frame: 2 years, assessed at every visit in that time period
  • Safety Issue:
  • Measure: Evaluate Overall Surival
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 20

Study Start Date: February 12, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Asymptomatic or symptomatic hormone naïve men with testosterone levels ≥100 ng/dL with previously treated localized prostate cancer who now have rising PSA's and five or fewer bone metastases.
  • Subjects who have been previously treated with definitive and/or adjuvant/salvage radiotherapy to the primary site and/or regional lymph nodes with concurrent ADT are allowed if the last hormone therapy delivered > 6 months prior. Subjects who have had fewer than 6 weeks of bicalutamide monotherapy for any reason within the 6 months prior to enrollment are eligible for the study, providing they have been off of the drug for at least 30 days prior to enrollment.
  • Histologic confirmation of Prostate Adenocarcinoma diagnosis.
  • Age ≥ 18 years.
  • Life expectancy of at least 2 years.
  • Acceptable hematology and serum biochemistry screening values:
  • White Blood Cell Count (WBC) ≥ 3,000/mm3
  • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
  • Platelet (PLT) count ≥ 100,000/mm3
  • Hemoglobin (HGB) ≥ 10 g/dl
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Albumin > 2.5 mg/dL
  • Willing and able to comply with the protocol, including follow-up visits and examinations.
  • Karnofsky Performance Score >60 or ECOG equivalent.
  • Radiographic confirmation of oligometastatic diagnosis via Bone Scan validated by either CT scan or MRI or PET/CT with Fluciclovine within the past 90 days.
  • Subjects who have not had surgical removal of their prostate and have a partner of child bearing potential must agree to use condoms beginning at the signing of the ICF until at least 6 months after the last dose of study drug. Because of the potential side effect on spermatogenesis associated with radiation, female partners of childbearing potential must agree to use a highly effective contraceptive method during and for 6 months after completing treatment
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • Men with known brain or visceral metastases (except regional lymph nodes as defined by section 5.2.5) defined by CT or MRI Imaging of the abdomen or pelvis.
  • Men who have had LHRH agonist or antagonist hormone therapy in the prior six months.
  • Men with >5 bony metastases.
  • Men with baseline serum Testosterone <100 ng/dL.
  • Men with new or progressing lymphadenopathy clearly consistent with prostate metastasis on imaging or proven by pathologic biopsy at any time three months or later following their initial definitive therapy.
  • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 3 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
  • Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride.
  • Use of dutasteride within 90 days prior to therapy. PSA should not be obtained prior to 90 days after stopping dutasteride.
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer.
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.
  • Men who will receive radical prostatectomy to the primary site.
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Spinal Cord compression will be defined as 360 degree circumferential obliteration of T2 cerebrospinal fluid signal around the spinal cord. Treatment should be completed for spinal cord compression.
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Cardiac failure New York Heart Association (NYHA) III or IV Crohn's disease or ulcerative colitis.
  • Bone marrow dysplasia.
  • Fecal incontinence.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Contact:

  • Brett Johnson
  • 801-587-4429

Location:

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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), "Vulnerable" or "Frail" , as Defined by the Criteria of the International Society of Geriatric Oncology (SIOG)


Condition: Prostate Cancer

Intervention:

  • Drug: Docetaxel every 3 weeks + Prednisone
  • Drug: Docetaxel weekly+ Prednisone

Purpose: The objective of this study is to evaluate the feasibility of two different chemotherapy protocols with adjusted doses for patients aged 75 and over who often have medical problems other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In both cases, chemotherapy is combined with prednisone. The protocol will be considered feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks). Additionally to this primary objective, efficacy will also be evaluated for both protocols as well as tolerance to treatment, quality of life and evolution of geriatric data.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01254513

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: Feasibility of 2 different protocols of Docetaxel chemotherapy
  • Time Frame: Up to 18 weeks (6 cycles of chemotherapy)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival
  • Time Frame: From randomization until death for any cause or last follow-up news (censored data)
  • Safety Issue:
  • Measure: Geriatric evaluation
  • Time Frame: At baseline, D1 of Cycle 1 and Cycle 4, at the end of treatment and at follow-up visits
  • Safety Issue:
  • Measure: Number of patients with Adverse Events
  • Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
  • Safety Issue:
  • Measure: Quality of Life
  • Time Frame: At baseline, D1 of the Cycle 4, at the end of the treatment and at the follow-up visits
  • Safety Issue:
  • Measure: Vital signs measurement
  • Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
  • Safety Issue:
  • Measure: Prostate-specific antigen (PSA) measurements
  • Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
  • Safety Issue:

Estimated Enrollment: 144

Study Start Date: November 2010

Phase: Phase 2

Eligibility:

  • Age: minimum 75 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Age >= 75
  • Histologically proven prostate adenocarcinoma
  • Metastatic disease, not pre-treated with chemotherapy refractory to castration
  • Hormone refractory prostate cancer is defined as follows:
  • Patients with documented testosterone castration (<0.50 ng / ml)
  • Patient who received prior hormonal therapy (either orchidectomy or Luteinizing hormone-releasing hormone (LHRH) agonist alone or combined with an anti-androgen)
  • Patients should continue primary androgen suppression by LHRH agonist (in case of non-surgical castration)
  • For patients treated with anti-androgens prior to inclusion, a wash-out period is required (4 weeks for flutamide and nilutamide, 6 weeks for other products) as well as measured progression after anti-androgen discontinuation.
  • Progressive disease under hormonotherapy, with progression defined by Increase of PSA level (two consecutive increases of PSA compared to baseline with a minimum of one week between both measurements) OR emergence of a new lesion OR measurable progressive disease (increase of a previous measurable lesion >= 25% in cross section) OR progressive bone metastases (defined only by the appearance of a new lesion on bone scan) OR progressive symptoms (defined as cancer pain Grade 2 according to the NCI-CTC V4.0, despite level 2 analgesics intake).
  • Patients of Groups 2 and 3 [ "vulnerable" and "frail"] of SIOG classification
  • WHO Performance Status (PS) >= 3
  • PSA >= 5 ng / ml
  • Neutrophils >= 2.109 /L
  • Platelets >= 100.109/L
  • Haemoglobin ≥ 9 g/dl
  • Bilirubin and SGOT / SGPT <1.5 x ULN (<= 2.5 x ULN if hepatic metastasis)
  • creatinine <= 2.5 x ULN
  • In case of previous palliative or analgesic radiotherapy, a minimum of 14 days must have elapsed between end of radiotherapy and inclusion into the study
  • Previous treatment with bisphosphonates should be continued without change during the study treatment and can not be initiated either within 28 days prior to study entry or during the study
  • Signed informed consent by patients, according to local regulations

Exclusion Criteria:

  • "healthy" or "terminal illness" Groups according to the recommendations of International Society of Geriatric Oncology (SIOG)
  • Concomitant or previous malignancy within 5 years prior the study (except basal or squamous in situ cell skin carcinoma)
  • Presence of brain metastasis symptoms
  • Prior treatment by intravenous radiopharmaceutical agent (e.g. Strontium 89, Samarium lexidronam) within 2 months before study entry
  • Initiation of a bisphosphonate therapy within 28 days prior to randomisation
  • Any concomitant anticancer treatment (radiotherapy, radiopharmaceutical agent, chemotherapy)
  • Patients with uncontrolled infection
  • Patients with peripheral neuropathy of grade> 1
  • Patients medically unstable (e.g. unstable diabetes, uncontrolled hypertension or decompensated heart failure or myocardial infarct within 3 months)
  • Gastro duodenal active ulcer
  • Hypersensitivity to study drugs
  • Treatment with any experimental drug within 30 days prior to or during the study
  • Psychological, familial, sociological or geographical location conditions which do not allow medical monitoring and compliance with study protocol.
  • Patients protected by the law or patients placed under protective supervision of adults

Contact:

  • Christine Orsini
  • +33.1.71.93.67.07

Locations:

  • Clinique Claude Bernard
  • Albi 81000 France
  • CHI Annemasse-Bonneville
  • Ambilly 74100 France
  • Centre Paul Papin
  • Angers 49933 France
  • CH de Blois
  • Blois 41016 France
  • Institut Bergonie
  • Bordeaux Cedex 33076 France
  • Centre Francois Baclesse
  • Caen 14076 France
  • CH Intercommunal
  • Castres 81108 France
  • Centre Hospitalier de Chambery
  • Chambery 73011 France
  • Centre Jean Perrin
  • Clermont-ferrand 63011 France
  • Clinique Sainte Marguerite
  • Hyeres 83400 France
  • Chd Vendee
  • La Roche Sur Yon 85925 France
  • Clinique Hartmann
  • Levallois-perret 92300 France
  • Centre Oscar Lambret
  • Lille 59020 France
  • Hôpital Saint Vincent de Paul
  • Lille 59020 France
  • Centre Leon Berard
  • Lyon 69373 France
  • Institut Paoli Calmettes
  • Marseille 13273 France
  • CHU Nimes
  • Nimes 30000 France
  • Chr Orleans
  • Orleans 45100 France
  • Institut Curie/Claudius Regaud
  • Paris 75005 France
  • Centre Hospitalier Lyon Sud
  • Pierre-benite France
  • Centre Hospitalier de La Region D'Annecy
  • Pringy Cedex 74374 France
  • Polyclinique Francheville
  • Périgueux 24000 France
  • Institut Curie - Centre Rene Huguenin
  • Saint-cloud 92210 France
  • Ico - Centre Rene Gauducheau
  • Saint-herblain Cedex 44885 France
  • CH de Senlis
  • Senlis 60300 France
  • Centre Paul Strauss
  • Strasbourg 67065 France
  • Hôpitaux du Léman
  • Thonon-les-bains 74200 France
  • Institut Claudius Regaud
  • Toulouse 31052 France
  • Polyclinique Du Parc
  • Toulouse 31078 France
  • Clinique Saint Jean du Languedoc
  • Toulouse 31400 France
  • Clinique Pasteur
  • Toulouse France

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer


Condition: Advanced Prostate Cancer

Intervention:

  • Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI

Purpose: This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02420977

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Primary Outcome Measures:

  • Measure: Response rate differences
  • Time Frame: baseline and after 2-3 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Biomarker changes
  • Time Frame: Baseline and at 2=3 months
  • Safety Issue:
  • Measure: Metabolic tumor uptake changes
  • Time Frame: baseline and then at 2-3 months
  • Safety Issue:
  • Measure: Gene expression changes
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:
  • Measure: Nodal metastatic disease changes
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:
  • Measure: All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:

Estimated Enrollment: 24

Study Start Date: December 6, 2018

Phase: Early Phase 1

Eligibility:

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

Inclusion Criteria:

  • Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.

Key Inclusion Criteria:

  • (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
  • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  • Prostate biopsy histology grade ≥ Gleason 8-10
  • Patients considered as candidates for and medically fit to undergo radiation and ADT
  • At least 10 days after most recent prostate biopsy

Exclusion Criteria:

  • will appear later in section 4 of the protocol)
  • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  • Prostate biopsy histology grade ≥ Gleason 8-10
  • Patients considered as candidates for and medically fit to undergo radiation and ADT
  • At least 10 days after most recent prostate biopsy Exclusion Criteria:
  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Hormone deprivation therapy
  • Investigational therapy for prostate cancer
  • Hemorrhagic cystitis or active prostatitis

Contact:

  • Phuoc Tran, M.D., Ph.D.
  • (410) 614-3880

Location:

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Baltimore Maryland 21287 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Utilising Circulating Tumour Cell (CTC) Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer: CTC-STOP Trial


Condition: Adenocarcinoma of the Prostate

Intervention:

  • Other: Active CTC Assessment

Purpose: CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic castration-resistant prostate cancer patients. This study will determine if serial CTC counts can be used as early markers of progression to direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without adversely impacting overall survival, when compared with standard approaches to guide treatment switch decisions.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03327662

Sponsor: Institute of Cancer Research, United Kingdom

Primary Outcome Measures:

  • Measure: Overall Survival
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: CTC-guided switch rates
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: CTC effects on chemotherapy
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Toxicity burden assessment
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Brief Pain Inventory
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: The Functional Assessment of Cancer Therapy-Prostate (FACT-P)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: EuroQoL Five Dimensions (EQ-5D)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Progression Free Survival
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Radiographic Progression Free Survival (rPFS)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Time to First Symptomatic Skeletal Related Event (SSRE)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Time to CTC Progression
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Circulating Tumour Cells (CTC) counts
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Prostate Specific Antigen (PSA) Counts
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Rate of CTC Response
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Rate of Pain response
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Health Economic assessment
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 1178

Study Start Date: January 11, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • 1. Written informed consent. 2. Age ≥18 years 3. Histologically confirmed diagnosis of adenocarcinoma of the prostate with availability of archival tumour tissue for molecular analyses (small cell prostate cancer is an exclusion); if no histological diagnosis has ever been acquired a fresh bone marrow trephine tumour biopsy confirming the presence of CRPC must be pursued. o Tumour tissue blocks will be requested for processing. Sections will be cut with the blocks then returned to the referring hospital. If the block is not available, at least ten tumour tissue sections (formalin-fixed paraffin-embedded) at 5 microns each will be requested. 4. Metastatic castration-resistant disease with only bone metastases, confirmed by bone scan (within 4 weeks) or CT (within 6 weeks), of starting this trial (Cycle 1 Day 1). Patients with local recurrence, and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion. 5. Systemic chemotherapy indicated for disease progression, defined as: o Bone Scan Progression: Two or more new documented bone lesions over previous 6 months. AND/OR o Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm the rising PSA is required. 6. Baseline laboratory values as stated below:
  • Creatinine ≤1.5 x upper limit of normal (ULN)
  • Bilirubin ≤1.0 x ULN
  • SGOT (AST) and SGPT (ALT) ≤2.5x ULN
  • Castrate serum testosterone level (<50 ng/dL-or-<1.7 nmol/L)
  • ANC ≥1.5 x 109cells/L
  • Platelet count ≥100 x 109/L
  • PSA ≥ 5ng/mL 7. CTC levels ≥ 5 cells / 7.5 mL 8. Prior treatment with abiraterone and/or enzalutamide, discontinued due to disease progression. 9. Patient willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (either agonists or antagonists) throughout the study, unless treated with bilateral orchiectomy. 10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (see Appendix A2). 11. At least 3 weeks should have elapsed since stopping any investigational agent at the time of randomisation. More than 4 weeks since completion of radiotherapy, other than when a single palliative fraction is administered when only a two week interval is required before trial treatment commencement. 12. Patient recovered from any therapy-related toxicity to ≤ grade 2, (except alopecia, anaemia and any signs or symptoms of androgen deprivation therapy). 13. Patient willing to comply with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 14. Participants must be surgically sterile or must agree to use effective contraception during the period of the therapy and for 12 months after the last dose of study treatment. Effective contraception is defined as double barrier contraception (e.g. condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).

Exclusion Criteria:

  1. Received any prior cytotoxic chemotherapy as treatment for castration-resistant prostate cancer. Patients that have received chemotherapy for hormone-sensitive metastatic prostate cancer will be allowed onto the trial, if the patient merits retreatment with docetaxel and at least 12 months has elapsed since the patient has completed that previous docetaxel therapy.
  2. Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
  3. Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomisation with the exception of the continuous LHRH analogues.
  4. History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. Brain imaging for asymptomatic patients is not required.
  5. Current symptomatic cord compression requiring surgery or radiation therapy. (Once the patient is successfully treated the patient will be considered eligible for the study).
  6. Active second malignancy (except non-melanoma skin or superficial bladder cancer) defined as requiring anticancer therapy or within the previous two years.
  7. Serious medical conditions such as heart failure, myocardial infarction, pulmonary thromboembolism within 12 months; stroke or treatment of a major active infection within 3 months of randomisation, as well as any significant medical illness that in the opinion of the Investigator would preclude protocol therapy.
  8. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
  9. Hypersensitivity to the active substance, to any of its excipients (including polysorbate 80) or to other taxanes.
  10. Concomitant vaccination with yellow fever vaccine
  11. Concomitant use of medicinal products that are strong CYP3A inducers

Contact:

  • CTC-STOP Trial Manager

Locations:

  • The Royal Marsden Hospital
  • Sutton Surrey SM2 5PT United Kingdom
  • Velindre Cancer Centre
  • Cardiff United Kingdom
  • Western General Hospital
  • Edinburgh United Kingdom
  • University College London Hospital
  • London United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 1b/2 Study of the Oral CDK4/6 Inhibitor LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in Metastatic Castration Resistant Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: Docetaxel
  • Drug: Ribociclib
  • Drug: Prednisone
  • Drug: Filgrastim

Purpose: This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic CRPC with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02494921

Sponsor: Rahul Aggarwal

Primary Outcome Measures:

  • Measure: Maximally Tolerated Dose (MTD) measured by CTCAE v.4.03
  • Time Frame: Up to 2 years (Phase 1b only)
  • Safety Issue:
  • Measure: Progression-Free Survival
  • Time Frame: 6 months (Phase 2 only)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Median Progression-Free Survival
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Objective Response Rate
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Median Duration of Response measured by RECIST v.1.1
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Prostate-Specific Antigen (PSA) Response Rate
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: PSA Progression-Free Survival
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Adverse Events
  • Time Frame: Up to 2 years
  • Safety Issue:

Estimated Enrollment: 47

Study Start Date: September 25, 2015

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed prostate cancer. Small cell/neuroendocrine differentiated allowed but not required for study participation.
  • Progressive metastatic prostate cancer (as defined below in Item #5) despite castrate levels of testosterone (< 50 ng/dL).
  • Patients may have either non-measurable disease OR measurable disease
  • Progressive disease during (or within 4 weeks of completion) with abiraterone, enzalutamide, and/or ARN-509 based on any one of the following: 1. For patients with measurable disease, progression by the RECIST criteria. 2. PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart. If the confirmatory PSA (#3) value is less (i.e., #3b) than the screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression for the purposes of eligibility. 3. Radionuclide bone scan: At least two new foci consistent with metastatic lesions
  • Testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.
  • Patients treated with first generation anti-androgen as most recent systemic therapy (bicalutamide, nilutamide) must have at least 4 weeks elapsed from treatment discontinuation to start of protocol therapy with evidence of disease progression by PCWG2 criteria following discontinuation of prior anti-androgen.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count ≥ 1.5 × 109/L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin ≥ 9 g/dl.
  • Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits before first dose of study medication.
  • International normalized ratio (INR) ≤ 1.5 unless on direct thrombin inhibitor at time of study entry.
  • Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
  • In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN). If the patient has liver metastases, ALT and AST <5 x ULN
  • Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome.
  • No other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of study therapy.
  • Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method).
  • Age ≥ 18 years
  • Written informed consent must be obtained prior to any screening procedures and according to local guidelines.

Exclusion Criteria:

  • Patient has a known hypersensitivity to ribociclib or any of its excipients, or prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor.
  • Prior chemotherapy for metastatic castration-resistant prostate cancer. Chemotherapy administered in the castration-sensitive setting is allowed provided last dose of chemotherapy was greater than 6 months prior to study entry
  • Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal cell skin cancer, squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
  • Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
  • Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement
  • Patient is not able to swallow oral medication and/or has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or significant small bowel resection).
  • Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Patient has a left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) obtained during Screening.
  • History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening. Patients with rate-controlled atrial fibrillation or flutter are permitted.
  • Bradycardia (heart rate < 50 bpm at rest), by ECG or pulse, at screening
  • Congenital long QT syndrome or family history of long QT syndrome
  • Any of the following abnormalities on screening 12-lead ECG:
  • QT interval with Fridericia's correction (QTcF) > 450 msec
  • Bradycardia (heart rate < 50 bpm at rest)
  • Tachycardia (heart rate > 100 bpm at rest)
  • PR interval > 220msec,
  • QRS interval >109 msec
  • Documented cardiomyopathy
  • Systolic blood pressure >160 mmHg or <90 mmHg at screening
  • AST and/or ALT > 1.5 x ULN with concomitant alkaline phosphatase > 2.5 x ULN
  • Patient receiving any of the following medications within 7 days of day 1 of study treatment.
  • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
  • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • That have a known risk to prolong the QT interval or induce Torsades de Pointes.
  • Herbal preparations/medications
  • Patient is currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting study drug at a dose greater than the equivalent of 10 mg prednisone/day, or who have not fully recovered from the side effects of such treatment
  • The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, direct thrombin inhibitors, low molecular weight heparin (LMWH) or fondaparinux is allowed.
  • Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
  • Major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
  • Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia), and/or in whom ≥25% of the bone marrow was irradiated.
  • Patient has a known history of HIV infection (testing not required)
  • Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 4.03 to less than or equal to Grade 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study).
  • Patients with chronic liver disease with a Child-Pugh score B or C.
  • Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
  • Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of study investigator.
  • History of bleeding diathesis. Patients receiving anti-coagulation must be able safely interrupt treatment for tumor biopsy (Phase 2 only)
  • Patient has a history of non-compliance to medical regimen or inability to grant consent

Contact:

  • Rahul Aggarwal, MD
  • 877-827-3222

Locations:

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • San Francisco California 94115 United States
  • Northwestern University
  • Chicago Illinois 60611 United States
  • University of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.


Condition: Progression of Prostate Cancer

Intervention:

  • Device: Whole Body MRI
  • Procedure: Focal Salvage Therapy
  • Procedure: MRI Targeted biopsies

Purpose: Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01883128

Sponsor: University College London Hospitals

Primary Outcome Measures:

  • Measure: Accuracy of whole body MRI in identifying distant disease
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Can multiparametric MRI accurately detect localised recurrent prostate cancer
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 177

Study Start Date: April 2014

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy
  2. Biochemical failure as defined by the Phoenix criteria (PSA nadir + 2ng/ml)
  3. Men considering local salvage treatment for radio-recurrent disease
  4. Life expectancy of 5 years or more

Exclusion Criteria:

  1. Have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months
  2. Unable to have MRI scan as defined by standard care practice
  3. Metallic implant likely to cause artefact and reduce scan quality
  4. PSA doubling time of 3 months or less
  5. PSA value 20ng/ml or greater
  6. Prior prostate biopsies following biochemical failure
  7. Any prior local intervention to the prostate (e.g., laser/electrical resection or incision, cryotherapy, HIFU, any other ablative modality, any other radiotherapy, any other prostate injection therapy for symptoms or cancer control)
  8. Unable to have general or regional anaesthesia
  9. Unable to give informed consent

Contact:

  • Abi A Kanthabalan, MBChB
  • +44(0)2034479194

Locations:

  • Hampshire Hospitals NHS Trust
  • London NW1 2BU United Kingdom
  • University College London Hospitals
  • London NW1 2BU United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Randomised Phase II Study of Enzalutamide (MDV3100) in Combination With AZD5363 in Patients With Metastatic Castration‐Resistant Prostate Cancer (RE‐AKT)


Condition: Adenocarcinoma of the Prostate

Intervention:

  • Drug: AZD5363
  • Drug: Enzalutamide

Purpose: A multicentre prospective, randomised, phase II interventional study in mCRPC patients previously treated with 1‐2 lines of chemotherapy and at least 12 weeks of abiraterone with a safety run‐in and single stage phase II expansion cohort.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02525068

Sponsor: Institute of Cancer Research, United Kingdom

Primary Outcome Measures:

  • Measure: Phase I: Type, frequency, severity, seriousness and relatedness of adverse events
  • Time Frame: 35 days
  • Safety Issue:
  • Measure: Phase I: Laboratory abnormalities will be assessed according to NCI CTCAE v4
  • Time Frame: 35 days
  • Safety Issue:
  • Measure: Randomised phase II: Best overall tumour response
  • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to an estimated 22-24 months
  • Safety Issue:
  • Measure: Phase II expansion: Best overall tumour response
  • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to an estimated 22-24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Phase I and phase II expansion only - Pharmacokinetic (PK) assay analyses
  • Time Frame: 35 days
  • Safety Issue:
  • Measure: Phase I - Antitumour activity of the combination
  • Time Frame: 35 days
  • Safety Issue:
  • Measure: Randomised phase II and phase II expansion - Overall survival and radiographic progression free survival
  • Time Frame: From date of randomization/trial entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to (estimated) 12 months
  • Safety Issue:
  • Measure: Maximum PSA decline and circulating tumour cell (CTC) fall
  • Time Frame: 12 weeks
  • Safety Issue:
  • Measure: Pain Palliation - Randomised phase II only
  • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to (estimated) 12 months
  • Safety Issue:
  • Measure: Number of Adverse events will be graded according to NCI-CTCAE v4
  • Time Frame: From trial entry until 30 days post date of last dose or death from any cause
  • Safety Issue:

Estimated Enrollment: 136

Study Start Date: December 2014

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Written informed consent. 2. Histological diagnosis of adenocarcinoma of the prostate and with tumour tissue accessible for research analyses for this trial (e.g. Phosphatase and Tensin Homologue (PTEN) testing). Patients who have no histological diagnosis must be willing to undergo a biopsy to prove prostate adenocarcinoma. 3. Metastatic Castration-Resistant Prostate Cancer (mCRPC). 4. Progressed after 1 or 2 lines of taxane based chemotherapy. 5. Progressed after abiraterone (pre or post chemotherapy). Patients must have received at least 12 weeks of treatment with abiraterone. 6. Age ≥18 years. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 8. PSA ≥ 10ng/ml. 9. Documented willingness to use an effective means of contraception while participating in the study and for 12 months post last dose of treatment 10. Documented ongoing castrate serum testosterone <50 ng/dL (<2.0 nM). 11. Received prior castration by orchiectomy and/or ongoing Luteinizing Hormone-Releasing Hormone (LH-RH) agonist treatment. 12. Progression of disease by PSA utilizing PCWG2 criteria and at least another of the following criteria; 1. Bone scan: disease progression as defined by at least 2 new lesions on bone scan. 2. Soft tissue disease progression defined by modified RECIST 1.1. 3. Clinical progression with worsening pain and the need for palliative radiotherapy for bone metastases. PHASE I SAFETY RUN IN and EXPANSION COHORT
  • inclusion criteria: 13. Willing to have a biopsy to obtain tumour tissue for biomarker analyses prior to and after treatment. SINGLE STAGE PHASE II EXPANSION COHORT ONLY
  • inclusion criteria: 14. Prior exposure to enzalutamide of at least 12 weeks is required with documented disease progression biochemically and/or radiologically by PCWG2 or RECIST 1.1 criteria. Patients should have received at least 12 weeks of enzalutamide outside of the trial with evidence of disease progression (by PSA with 3 rising values as per PCWG2 criteria or soft tissue progression as per RECIST v1.1). 15. Archival tumour tissue available for the analysis of PTEN loss by the central laboratory

Exclusion Criteria:

  • 1. Prior treatment with enzalutamide (MDV3100) (not applicable for the phase I safety run in or for the single stage phase II expansion cohort, see inclusion criteria 14). 2. Prior treatment with Phosphatidylinositide 3‐kinases (PI3K), AKT, TOR kinase or Mammalian target of rapamycin (mTOR) inhibitors (see Appendix C). 3. Surgery, chemotherapy, or other anti‐cancer therapy within 4 weeks prior to trial entry/randomisation into the study (6 weeks for bicalutamide). Any other therapies for prostate cancer, other than Gonadotropin-releasing hormone (GnRH) analogue therapy, such as progesterone, medroxyprogesterone, progestins (megestrol), or 5‐alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued at least 2 weeks before the first dose of study drug. 4. Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry / randomisation. 5. Prior limited field radiotherapy within 2 weeks or wide field radiotherapy within 4 weeks of trial entry / randomisation. 6. History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism. 7. History of loss of consciousness or transient ischemic attack within the previous 12 months of trial entry / randomisation. 8. Known brain or leptomeningeal involvement. 9. Use of potent inhibitors or inducers of Cytochrome P450 isoenzymes (CYP3A4, CYP2C9, CYP2C19 and CYP2D6) (see Appendix B) within 2 weeks before trial entry / randomisation (3 weeks for St John's Wort) must be avoided. 10. Clinically significant abnormalities of glucose metabolism as defined by any of the following: 1. Diagnosis of diabetes mellitus type I 2. Fasting plasma glucose ≥ 7.0 mmol/L for those patients without a pre-existing diagnosis of Type 2 diabetes mellitus ≥ 9.3 mmol/L for those patients with a pre-existing diagnosis of Type 2 diabetes mellitus 3. Glycosylated haemoglobin (HbA1C) ≥8.0% at screening (63.9 mmol/mol) (conversion equation for HbA1C [IFCC‐HbA1C (mmol/mol) = [DCCT‐HbA1C (%)
  • 2.15] x 10.929) 4. Requirement for insulin for routine diabetic management and control 5. Requirement for more than two oral hypoglycaemic medications for routine diabetic management and control 11. Inadequate organ and bone marrow function as evidenced by: 1. Haemoglobin <85 g/L 2. Absolute neutrophil count <1.0 x 109/L 3. Platelet count < 75 x 109/L 4. Albumin ≤25 g/dL 5. Aspartate Transaminase (AST) / Serum Glutamic‐Oxaloacetic Transaminase (SGOT) and/or Alanine Transaminase (ALT) / Serum Glutamic Pyruvate Transaminase (SGPT) ≥ 2.5 x Upper Limit of Normal (ULN) (≥ 5 x ULN if liver metastases present) 6. Total bilirubin ≥ 1.5 x ULN (except for patient with documented Gilbert's disease) 7. Serum Creatinine > 1.5 x ULN 12. Inability or unwillingness to swallow oral medication. 13. Malabsorption syndrome or other condition that would interfere with enteral absorption. 14. Any of the following cardiac criteria; 1. Mean resting corrected QT interval (QTcF) >470msec obtained from 3 consecutive ECGs taken within 5 minutes 2. Any clinically important abnormalities in rhythm, conduction, or morphology of a resting ECG (e.g., complete left bundle branch block, third degree heart block) 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years‐of‐age, or any concomitant medication known to prolong the QT interval or with a potential for Torsades de Pointes 4. Experience of any of the following procedures or conditions in the preceding six months:coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) ≥ Grade2 5. Uncontrolled hypotension defined as
  • systolic blood pressure (BP) <90 mmHg and/or diastolic BP <50 mmHg 15. Clinically significant history of liver disease consistent with Child‐Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis. 16. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications. 17. Need for chronic corticosteroid therapy of >10 mg of prednisolone or >0.5mg of dexamethasone per day or an equivalent dose of other anti‐inflammatory corticosteroid, for the use of concomitant steroids on this trial please refer to section 12.1. Patients in which corticosteroids cannot be stopped prior to entering the trial are allowed a maximum of 10mg of prednisolone per day or equivalent. In the case of corticosteroid discontinuation, a 2‐week (14 days) washout is required with a mandatory PSA check prior to starting the trial. If the PSA has declined compared to the value obtained prior to stopping corticosteroids, patients will not be eligible for study. Patients can only enter the study with a confirmed PSA increase. 18. Malignancies other than prostate cancer within 5 years prior to trial entry / randomisation, except for adequately treated basal or squamous cell skin cancer. 19. Unresolved clinically significant toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy. 20. Inability to comply with study and follow‐up procedures. 21. Patients with predominately small cell or neuroendocrine differentiated prostate cancer are not eligible.

Contact:

  • RE-AKT Trial Manager

Location:

  • Royal Marsden Hospital
  • Sutton Surrey SM2 5PT United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer


Condition: Metastatic Prostate Cancer

Intervention:

  • Drug: Niraparib
  • Drug: Abiraterone Acetate
  • Drug: Prednisone
  • Drug: Placebo

Purpose: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03748641

Sponsor: Janssen Research & Development, LLC

Primary Outcome Measures:

  • Measure: Radiographic Progression Free Survival (rPFS)
  • Time Frame: Approximately 40 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Time to Chronic Opioid Use
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Time to Pain Progression
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Time to Initiation of Cytotoxic Chemotherapy
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Observed Plasma Concentrations of Niraparib
  • Time Frame: Cycle 2: Day 1 (Predose, between 1 to 3 and 3 to 6 hours postdose); Cycle 3: Day 1 (Predose); Cycles 4 to 7: Day 1 (Predose or at least 3 hours postdose); each Cycle of 28 days
  • Safety Issue:
  • Measure: Observed Trough Plasma Concentrations of Abiraterone
  • Time Frame: Cycles 2 and 3 (Each Cycle of 28 days): Day 1 (Predose)
  • Safety Issue:
  • Measure: Number of Participants with Treatment-Emergent Adverse events (TEAEs)
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Number of Participants with Treatment-Emergent Adverse events by Severity
  • Time Frame: Approximately up to 73 months
  • Safety Issue:
  • Measure: Number of Participants with Laboratory Abnormalities as Measure of Safety
  • Time Frame: Approximately up to 73 months
  • Safety Issue:

Estimated Enrollment: 1000

Study Start Date: January 25, 2019

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Deoxyribonucleic acid (DNA)-repair gene defects (DRD) status (as identified by the sponsor's required assays) as follows: 1. Cohort 1: positive for DRD 2. Cohort 2: not positive for DRD (i.e. No DRD)
  • Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry as evidenced by prostate-specific antigen (PSA) progression or radiographic progression
  • Able to continue GnRHa during the study if not surgically castrate
  • Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria:

  • Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
  • Systemic therapy (example, enzalutamide, docetaxel) in the metastatic castration-resistant prostate cancer (mCRPC) setting with the exception of less than 4 months of abiraterone acetate-Prednisone (AA-P) prior to randomization
  • Symptomatic brain metastases
  • History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  • Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Contact:

  • Study Contact
  • 844-434-4210

Locations:

  • Urological Associates of Southern Arizona, P.C.
  • Tucson Arizona 85741 United States
  • San Bernardino Urological Associates
  • San Bernardino California 92404 United States
  • University of California San Francisco
  • San Francisco California 94158 United States
  • Kaiser Permanente Medical Center
  • Vallejo California 95119 United States
  • Urology Associates of Denver
  • Englewood Colorado 80113 United States
  • Foothills Urology - Golden Off
  • Golden Colorado 80401-5027 United States
  • VA Connecticut Healthcare
  • West Haven Connecticut 06516 United States
  • Bay Pines VA Healthcare System
  • Bay Pines Florida 33744 United States
  • Advanced Urology Institute
  • Daytona Beach Florida 32114 United States
  • University of Florida
  • Jacksonville Florida 32209 United States
  • Veterans Affairs Medical Ctr
  • Hines Illinois 60141 United States
  • University of Kansas Medical Center
  • Kansas City Kansas 66160 United States
  • Norton Healthcare
  • Louisville Kentucky 40202 United States
  • Rcca Md, Llc
  • Bethesda Maryland 20817 United States
  • Chesapeake Urology Research Associates
  • Towson Maryland 21204 United States
  • Massachusetts General
  • Boston Massachusetts 02114 United States
  • Kansas City Veterans Affairs Medical Center
  • Kansas City Missouri 64128 United States
  • Adult Pediatric Urology & Urogynecology, P.C
  • Omaha Nebraska 68114 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • Delaware Valley Urology, LLC
  • Mount Laurel New Jersey 08054 United States
  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
  • New York New York 10029 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Upstate Cancer Center
  • Syracuse New York 13210 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17604 United States
  • VA Pittsburgh
  • Pittsburgh Pennsylvania 15240 United States
  • Carolina Urologic Research Center
  • Myrtle Beach South Carolina 29572 United States
  • University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Utah Cancer Specialists
  • Salt Lake City Utah 84106 United States
  • Salem VA Medical Center
  • Salem Virginia 80113 United States
  • Urology of Virginia, PLCC
  • Virginia Beach Virginia 23462 United States
  • NorthWest Medical Specialties, PLLC
  • Tacoma Washington 98405 United States
  • Hospital Aleman
  • Buenos Aires C1118AAT Argentina
  • Hospital Italiano de Buenos Aires
  • C.a.b.a. C1181ACF Argentina
  • Fundación CENIT para la Investigación en Neurociencias
  • Capital Federal CP 1125 Argentina
  • Centro de Urologia (CDU)
  • Ciudad Automoma Buenos Aires C1120AAT Argentina
  • CEMIC Saavedra
  • Ciudad Autonoma Buenos Aires C1431FWN Argentina
  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Cordoba 5000 Argentina
  • Hospital Privado - Centro Medico de Cordoba
  • Cordoba X5016KEH Argentina
  • Instituto de Investigaciones Clinicas Mar del Plata
  • Mar del Plata B7600FZN Argentina
  • Hospital Privado de Comunidad
  • Mar del Plata B7602CBM Argentina
  • Centro de Investigacion Pergamino SA
  • Pergamino B2700CPM Argentina
  • Sanatorio Britanico de Rosario
  • Rosario 2000 Argentina
  • Sanatorio Parque
  • Rosario S2000SDV Argentina
  • ARS Médica
  • San Salvador de Jujuy Y4600AFW Argentina
  • Royal Adelaide Hospital
  • Adelaide 5116 Australia
  • Pindara Private Hospital
  • Benowa 4217 Australia
  • Sunshine Coast University Hospital
  • Birtinya 4575 Australia
  • Princess Alexandra Hospital
  • Brisbane 4102 Australia
  • Chris O'Brien Lifehouse
  • Camperdown 2050 Australia
  • St. Vincent's Hospital Sydney
  • Darlinghurst 2010 Australia
  • Royal Hobart Hospital
  • Hobart 7000 Australia
  • Macquarie University
  • Macquarie University 2109 Australia
  • Cabrini Health
  • Malvern 3144 Australia
  • Peter MacCallum Cancer Centre
  • Melbourne 3000 Australia
  • Fiona Stanley Hospital
  • Murdoch 6150 Australia
  • Hollywood Private Hospital
  • Nedlands 6009 Australia
  • Prince Of Wales Hospital
  • Randwick 2031 Australia
  • Sydney Adventist Hospital
  • Wahroonga 2076 Australia
  • Wollongong Private Hospital
  • Wollongong 2500 Australia
  • OLV Ziekenhuis Aalst
  • Aalst 9300 Belgium
  • ZNA Middelheim
  • Antwerpen 2020 Belgium
  • Grand Hôpital de Charleroi, site Notre Dame
  • Charleroi 6000 Belgium
  • AZ Maria Middelares
  • Gent 9000 Belgium
  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Liege B-4000 Belgium
  • Hospital Do Cancer De Barretos - Fundacao Pio Xii
  • Barretos 14784-400 Brazil
  • PERSONAL - Oncologia de Precisão e Personalizada
  • Belo Horizonte 30130-090 Brazil
  • Hospital Sírio Libanes Unidade Brasilia
  • Brasilia 70200-730 Brazil
  • CIONC - Centro Integrado de Oncologia de Curitiba
  • Curitiba 80810-050 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
  • Clínica de Neoplasias Litoral Ltda.
  • Itajai 88301-220 Brazil
  • Instituto Joinvilense De Hematologia e Oncologia
  • Joinville 89201260 Brazil
  • Centro de Tratamento de câncer Medradius
  • Maceió 57052-765 Brazil
  • Liga Norte Riograndense Contra O Cancer
  • Natal 59075-740 Brazil
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre 90020-090 Brazil
  • Instituto Nacional do Cancer - INCA
  • Rio de Janeiro 20230-130 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
  • CEPHO - Faculdade de Medicina do ABC
  • Santo André 09060-870 Brazil
  • Santa Casa de Misericordia de São Paulo
  • Sao Paulo 01221-020 Brazil
  • Instituto de Ensino E Pesquisa Sao Lucas
  • Sao Paulo 01236-030 Brazil
  • ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA
  • Sao Paulo 01246-000 Brazil
  • Fundacao Antonio Prudente
  • Sao Paulo 01509900 Brazil
  • IBCC Instituto Brasileiro de Controle do Cancer
  • Sao Paulo 03102-002 Brazil
  • IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
  • Sorocaba 18030-075 Brazil
  • Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO
  • São Paulo 04039-004 Brazil
  • Instituto do Cancer De Tres Lagoas
  • Três Lagoas 79601-001 Brazil
  • Instituto do Cancer De Tres Lagoas
  • Três Lagoas 79603110 Brazil
  • MHAT Deva Maria
  • Burgas 8001 Bulgaria
  • UMHAT 'Dr. Georgi Stranski', EAD
  • Pleven 5800 Bulgaria
  • Complex Oncology Center - Plovdiv EOOD
  • Plovdiv 4004 Bulgaria
  • Specialized Hospital for Active Treatment in Oncology EAD
  • Sofia 1756 Bulgaria
  • SHATOD 'Dr. Marko Antonov Markov'
  • Varna 9010 Bulgaria
  • Comprehensive Cancer Center
  • Vratsa 3001 Bulgaria
  • Southern Alberta Institute of Urology / Prostate Cancer Centre
  • Calgary Alberta T2V 1P9 Canada
  • British Columbia Cancer Agency (BCCA) - Vancouver Centre
  • Vancouver British Columbia V5Z 4E6 Canada
  • British Columbia Cancer Agency - Vancouver Island Centre
  • Victoria British Columbia V8R 6V5 Canada
  • McMaster Institute of Urology
  • Hamilton Ontario L8N 4A6 Canada
  • Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
  • Kingston Ontario K7L 3N6 Canada
  • Sunnybrook Health Sciences Center
  • Toronto Ontario M4N 3M5 Canada
  • University Health Network (UHN) Princess Margaret Cancer Centre
  • Toronto Ontario M5G 2M9 Canada
  • Centre de Recherche du CHUM
  • Montreal Quebec H2X 0A9 Canada
  • Saskatoon Cancer Centre
  • Saskatoon Saskatchewan S7N 4H4 Canada
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing 100021 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 Third Hospital
  • Beijing 100191 China
  • Beijing Hospital
  • BeiJing 100730 China
  • Sichuan Provincial People's Hospital
  • Chengdu 610072 China
  • Southwest Hospital, The Third Military Medical University
  • Chongqing 400025 China
  • Chongqing Cancer hospital
  • Chongqing 400030 China
  • Fujian Medical University Union Hospital
  • Fuzhou 350001 China
  • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
  • Guangzhou 510120 China
  • Guangzhou First Municipal People's Hospital
  • GuangZhou 510180 China
  • The First Affiliated hospital of Anliui Medical University
  • Hefei China
  • Nanjing Drum Tower Hospital
  • Nanjing 210008 China
  • Jiangsu Cancer Hospital
  • Nanjing 210009 China
  • Drug clinical trial ethics committee of Ningbo First Hospital
  • Ningbo 315010 China
  • Fudan University Shanghai Cancer Center
  • Shanghai 200032 China
  • Shanghai Zhongshan Hospital
  • ShangHai 200032 China
  • Huashan Hospital Fudan University
  • Shanghai 200040 China
  • ShangHai Huadong Hospital
  • ShangHai 200040 China
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • ShangHai 200127 China
  • The Fifth People's Hospital of Shanghai, Fudan University
  • ShangHai 200240 China
  • The First Affiliated Hospital of Soochow University
  • Suzhou 215006 China
  • Tianjin Medical University Cancer Hospital
  • Tianjin 300060 China
  • The Central Hospital of Wuhan
  • Wuhan 430014 China
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Wuhan 430030 China
  • Wuxi People's Hospital
  • Wuxi 214023 China
  • First Affiliated Hospital, Xi'an Jiaotong University
  • Xi'an 710061 China
  • Fakultni nemocnice Hradec Kralove
  • Hradec Králove 500 05 Czechia
  • Krajská nemocnice Liberec
  • Liberec 460 63 Czechia
  • Uromedical Center s.r.o.
  • Olomouc 77900 Czechia
  • Multiscan s.r.o.
  • Pardubice 53203 Czechia
  • Fakultni nemocnice Plzen, Urologicka klinika
  • Plzen 305 99 Czechia
  • Urologicka klinika 1.LF UK a VFN
  • Praha 2 120 00 Czechia
  • Thomayerova nemocnice, Onkologicka klinika
  • Praha 4 140 59 Czechia
  • CHRU De Besancon
  • Besancon 25030 France
  • Institut Bergonié
  • Bordeaux 33000 France
  • Centre Jean Perrin
  • Clermont Ferrand 63011 France
  • Centre Leon Bérard
  • Lyon 69008 France
  • Institut Regional du Cancer de Montpellier Val d'Aurelle
  • Montpellier 34298 France
  • Polyclinique de Gentilly
  • Nancy 54100 France
  • Centre Antoine Lacassagne
  • Nice Cedex 2 06189 France
  • Hopital Europeen Georges-Pompidou
  • Paris Cedex 15 75908 France
  • Institut de Cancérologie de l'Ouest (ICO)
  • Saint Herblain 44805 France
  • HIA Begin
  • Saint Mande 94163 France
  • Hôpitaux Universitaire de Strasbourg -CHU
  • Strasbourg 67091 France
  • Charite - Universitatsmedizin Berlin (CCM)
  • Berlin 12200 Germany
  • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
  • Braunschweig 38126 Germany
  • Urologicum Duisburg
  • Duisburg 47179 Germany
  • Universitätsklinikum des Saarlandes
  • Homburg 66424 Germany
  • Klinik und Poliklinik für Urologie
  • Köln 50937 Germany
  • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
  • Magdeburg 39120 Germany
  • Universitaetsklinikum Muenster
  • Muenster 48149 Germany
  • Studienpraxis Urologie Drs. Feyerabend
  • Nuertingen 72622 Germany
  • Semmelweis Egyetem, Urológia Klinika
  • Budapest 1082 Hungary
  • Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
  • Budapest 1122 Hungary
  • Szent János Kórház és Észak-budai Egyesített Kórházak
  • Budapest 1125 Hungary
  • Debreceni Egyetem Klinikai Kozpont
  • Debrecen 4032 Hungary
  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
  • Gyula 5700 Hungary
  • Uro-Clin Kft.
  • Pécs 7621 Hungary
  • Szegedi Tudomanyegyetem
  • Szeged 6725 Hungary
  • Asaf Harofe Medical Center
  • Beer Yaakov 60930 Israel
  • Rambam Health Care Campus
  • Haifa 31096 Israel
  • Rabin Medical Center
  • Petah Tikva 49100 Israel
  • Sheba Medical Center Tel Hashomer
  • Ramat Gan 52621 Israel
  • AUSL Romagna - Ospedale di Faenza
  • Faenza 48018 Italy
  • Ospedale San Raffaele
  • Milano 20132 Italy
  • ASST Grande Ospedale Metropolitano Niguarda
  • Milano 20162 Italy
  • Oncologia Medica A - Ist Naz Tumori G Pascale
  • Napoli 80131 Italy
  • Istituto Oncologico Veneto Iov Irccs Padova
  • Padova 35128 Italy
  • Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
  • Parma 43126 Italy
  • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
  • Perugia 06132 Italy
  • Azienda Ospedaliero Universitaria Pisana
  • Pisa 56126 Italy
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Roma 00168 Italy
  • Campus Bio-Medico di Roma
  • Roma 128 Italy
  • Azienda Ospedaliera S. Maria Terni
  • Terni 5100 Italy
  • A.O.U. Città della Salute e della Scienza
  • Torino 10126 Italy
  • Ospedale Santa Chiara Trento
  • Trento 38122 Italy
  • Pusan National University Hospital.
  • Busan 49241 Korea, Republic of
  • Kyungpook National University Chilgok Hospital
  • Daegu 41404 Korea, Republic of
  • Keimyung University Dongsan Hospital
  • Daegu 42601 Korea, Republic of
  • Chungnam National University Hospital
  • Daejeon 35015 Korea, Republic of
  • National Cancer Center
  • Goyang-Si 10408 Korea, Republic of
  • Chonnam National University Hospital
  • Gwangju 61469 Korea, Republic of
  • Seoul National University Bundang Hospital
  • Seongnam-si 13620 Korea, Republic of
  • Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Severance Hospital
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Gangnam Severance Hospital
  • Seoul 06273 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • Seoul St. Mary's Hospital
  • Seoul 06591 Korea, Republic of
  • Ajou University Hospital
  • Suwon 443-721 Korea, Republic of
  • Hospital Pulau Pinang
  • George Town 10990 Malaysia
  • Hospital Sultan Ismail
  • Johor Bahru 81100 Malaysia
  • Hospital Likas
  • Kota Kinabalu 88996 Malaysia
  • Hospital Kuala Lumpur
  • Kuala Lumpur 53000 Malaysia
  • University Malaya Medical Centre
  • Kuala Lumpur 59100 Malaysia
  • Sarawak General Hospital
  • Kuching 93586 Malaysia
  • iBiomed Research Unit
  • Aguascalientes 20010 Mexico
  • Mexico Centre for Clinical Research, S.A. de C.V.
  • Ciudad de Mexico 03100 Mexico
  • Consultorio de Especialidad en Urologia Privado
  • Durango 34000 Mexico
  • Centro Medico Nacional Siglo XXI IMSS
  • Mexico 06720 Mexico
  • Avix Investigacion Clinica, S.C.
  • Monterrey 64710 Mexico
  • Consultorio Privado
  • Zapopan 45040 Mexico
  • NKI-AVL, Amsterdam
  • Amsterdam 1066 CX Netherlands
  • Universitair Medisch Centrum Groningen
  • Groningen 9713 GZ Netherlands
  • Atrium Medisch Centrum - Parkstad
  • Heerlen 6419 PC Netherlands
  • MC Haaglanden Lok Antoniushove - Afd.Interne - INT
  • Leidschendam 2262 BA Netherlands
  • St. Antonius Ziekenhuis (St. Antonius Hospital)
  • Nieuwegein 3430EM Netherlands
  • Canisius-Wilhelminaziekenhuis
  • Nijmegen 6532 SZ Netherlands
  • Erasmus MC
  • Rotterdam 3075 EA Netherlands
  • Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
  • Bydgoszcz 85-094 Poland
  • Centrum Onkologii im. Prof. F. Lukaszczyka
  • Bydgoszcz 85-796 Poland
  • Uniwersyteckie Centrum Kliniczne
  • Gdańsk 80-952 Poland
  • Szpitale Pomorskie Sp. z o.o.
  • Gdynia 81-519 Poland
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Lodz 93-509 Poland
  • Wielkopolskie Centrum Onkologii
  • Poznan 61-866 Poland
  • Urologica Praktyka Lekarska Adam Marcheluk
  • Siedlce 08-110 Poland
  • Pomorski Uniwersytet Medyczny w Szczecinie
  • Szczecin 70-111 Poland
  • Szpital Św. Elżbiety Mokotowskie Centrum Medyczne
  • Warszawa 02-616 Poland
  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie
  • Warszawa 02‐781 Poland
  • Dolnoslaskie Centrum Onkologii
  • Wrocław 53-413 Poland
  • Hospitais da universidade de Coimbra
  • Coimbra 3000-075 Portugal
  • Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
  • Coimbra 3000-075 Portugal
  • Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
  • Lisboa 1649-035 Portugal
  • Champalimaud Foundation Champalimaud Centre
  • Lisbon 1400-038 Portugal
  • H. Santo António - Centro Hospitalar do Porto
  • Porto 4099-001 Portugal
  • VA Caribbean Healthcare System
  • San Juan 00921 Puerto Rico
  • Altai Regional Oncology Dispensary
  • Barnaul 656049 Russian Federation
  • Ivanovo Regional Oncology Dispensary
  • Ivanovo 153040 Russian Federation
  • Naval Clinical Hospital
  • Kaliningrad 236029 Russian Federation
  • State Health Establishment Kursk Regional Oncology Dispensary
  • Kursk 305035 Russian Federation
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • Moscow City Clinical Hospital # 62
  • Moscow 125130 Russian Federation
  • Clinical Diagnostic Centre of Nizhny Novgorod Region
  • Nizhny Novgorod 603000 Russian Federation
  • Clinical Oncology Dispensary
  • Omsk 644013 Russian Federation
  • LLC Novaya Clinica
  • Pyatigorsk 357500 Russian Federation
  • Pyatigorsk Regional Oncology Dispensary
  • Pyatigorsk 357502 Russian Federation
  • Private Medical Institution Euromedservice
  • Saint Petersburg 196603 Russian Federation
  • Leningrad Regional Oncology Dispensary
  • Saint-Petersburg 191104 Russian Federation
  • Russian Scientific Center of Radiology and Surgical Technologies
  • Saint-Petersburg 197758 Russian Federation
  • Republican Oncology Dispensary
  • Saransk 430032 Russian Federation
  • Oncologic Dispensary No.2
  • Sochi 354057 Russian Federation
  • Tambov Regional Oncology Clinical Dispansary
  • Tambov 392013 Russian Federation
  • Tomsk Cancer Research Institute
  • Tomsk 634050 Russian Federation
  • Medical-sanitary unit 'Neftyanik'
  • Tyumen 625000 Russian Federation
  • Vologda Regional Oncological Dispensary
  • Vologda 160012 Russian Federation
  • Clinresco Centres Pty Ltd
  • Johannesburg 1619 South Africa
  • Clinical Research Unit
  • Pretoria 0001 South Africa
  • East Rand Urology Research Unit
  • Vosloorus 1475 South Africa
  • Hosp. Del Mar
  • Barcelona 08003 Spain
  • Hosp. de La Santa Creu I Sant Pau
  • Barcelona 08025 Spain
  • Hosp. Clinic I Provincial de Barcelona
  • Barcelona 08036 Spain
  • Hospital Juan Canalejo
  • Coruña 15006 Spain
  • Hosp. de Jerez de La Frontera
  • Jerez de la Frontera 11407 Spain
  • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid 28007 Spain
  • Hosp. Univ. Ramon Y Cajal
  • Madrid 28034 Spain
  • Hosp. Clinico San Carlos
  • Madrid 28040 Spain
  • Hosp. Virgen de La Victoria
  • Málaga 29010 Spain
  • Hosp. Quiron Madrid Pozuelo
  • Pozuelo de Alarcon 28223 Spain
  • Corporacio Sanitari Parc Tauli
  • Sabadell 08208 Spain
  • Hosp. Univ. Marques de Valdecilla
  • Santander 39008 Spain
  • Hosp. Univ. I Politecni La Fe
  • Valencia 46026 Spain
  • Södersjukhuset
  • Stockholm 11861 Sweden
  • Karolinska Universitetssjukhuset Solna
  • Stockholm 17176 Sweden
  • Akademiska Sjukhuset
  • Uppsala 751 85 Sweden
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung 807 Taiwan
  • China Medical University Hospital
  • Taichung 403 Taiwan
  • Taichung Veterans General Hospital
  • Taichung 40705 Taiwan
  • Tungs' Taichung MetroHarbor Hospital
  • Taichung 435 Taiwan
  • Chi Mei Medical Center - Yong Kang
  • Tainan 710 Taiwan
  • National Taiwan University Hospital
  • Taipei 100 Taiwan
  • Taipei Veterans General Hospital
  • Taipei 11217 Taiwan
  • Chang Gung Memorial Hospital
  • Taoyuan 33305 Taiwan
  • Cukurova University, Faculty of Medicine
  • Adana 01330 Turkey
  • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara 06200 Turkey
  • Ankara Sehir Hastanesi
  • Ankara 6560 Turkey
  • Akdeniz University Medical Faculty
  • Antalya 07070 Turkey
  • Trakya University Medical Faculty
  • Edirne 22030 Turkey
  • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul 34096 Turkey
  • Bakirkoy Training and Research Hospital
  • Istanbul 34147 Turkey
  • Istanbul Medeniyet University Goztepe Training and Research Hospital
  • Istanbul 34722 Turkey
  • Izmır Medical Park Hospital
  • Izmir 35575 Turkey
  • Kocaeli University Medical Faculty
  • Kocaeli 41380 Turkey
  • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
  • Cherkasy 18009 Ukraine
  • Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I.
  • Dnipo 49005 Ukraine
  • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
  • Dnipro 49100 Ukraine
  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
  • Dnipro 49102 Ukraine
  • Ivano-Frankivsk Regional Clinical Hospital
  • Ivano-Frankivsk 76008 Ukraine
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
  • Kharkiv 61037 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
  • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Lviv 79031 Ukraine
  • Ukrainian Medical Stomatological Academy
  • Poltava 36024 Ukraine
  • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
  • Uzhgorod 88000 Ukraine
  • Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
  • Zaporizhzhya 69600 Ukraine
  • Royal Blackburn Hospital
  • Blackburn BB2 3HH United Kingdom
  • Bristol Haematology and Oncology Centre
  • Bristol BS2 8ED United Kingdom
  • Royal Lancaster Infirmary
  • Lancaster LA1 4RP United Kingdom
  • UCL Cancer Institute
  • London WC1E 6DD United Kingdom
  • Royal Shrewsbury Hospital
  • Shrewsbury SY3 8XF United Kingdom
  • Torbay Hospital-Devon
  • Torquay TQ2 7AA United Kingdom
  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
  • Truro TR1 3LJ United Kingdom
  • New Cross Hospital
  • Wolverhampton WV10 0QP United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Randomized, Multicentre Phase II Trial of the Sequencing of Radium-223 and Docetaxel Plus Prednisone in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer (mCRPC)


Condition: Metastatic Castration-resistant Prostate Cancer

Intervention:

  • Drug: Radium-223
  • Drug: Docetaxel

Purpose: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: - Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) - Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03230734

Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Primary Outcome Measures:

  • Measure: health-related quality of life (HRQoL) clinical benefit
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: health-related quality of life (HRQoL ) clinical benefit
  • Time Frame: up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free survival (PFS)
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Total progression-free survival (TPFS)
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: toxicity
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Identification of markers predictive to clinical outcome
  • Time Frame: up to 36 months
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: September 1, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Patients must have histologically or cytologically confirmed adenocarcinoma of prostate 2. Two or more bone metastases confirmed by bone scintigraphy within 4 weeks prior to study entry 3. Symptomatic disease defined as regular use of opioid or non-opioid analgesic medication or treatment with external beam radiation therapy within the previous 12 weeks for cancer-related bone pain 4. Known castration-resistant disease, defined according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria as: castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L) 5. Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks 6. Progressive disease based on prostate-specific antigen (PSA) and/or radiographic PCWG3 criteria:
  • Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart. Serum PSA at screening ≥ 1ng/mL is the minimal starting value
  • or radiographic disease progression based on documented bone lesions by the appearance of two or more new lesions by bone scintigraphy 7. Patients who failed treatment with any Androgen deprivation therapy (ADT) abiraterone and/or enzalutamide for CRPC that must be terminated at least 4 weeks before study entry. 8. Male, aged ≥18 years. 9. Life expectancy of greater than 6 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status≤2 . 11. Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000 x 10 9/L
  • absolute neutrophil count >1,500 x 10 9/L
  • platelets >100,000 x 10 9/L
  • total bilirubin within normal institutional limits
  • aspartate aminotransferase (AST/SGOT)/alanine aminotransferase (ALT/SGPT) <2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits 12. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after the last dose of radium-223 or docetaxel, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) . Two acceptable methods of birth control thus include condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months. 13. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). 14. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • 1. Patients who have had previous chemotherapy. 2. Patients who have had radiotherapy within 4 weeks prior to entering the study. 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. Concurrent use of other anticancer agents or treatments, with the following exceptions: luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, denosumab or bisphosphonate (eg, zoledronic acid). Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed. 5. Uncontrolled intercurrent 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. 6. Patients who received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. 7. Patients who received blood transfusion or erythropoietin within the last 4 weeks prior to start of study treatment. 8. Patients who received prior treatment with Radium-223. 9. Patients with malignant lymphadenopathy exceeding 3 cm in short-axis diameter, or symptomatic nodal disease, i.e. scrotal, penile or leg edema. 10. Other primary tumor (other than CRPC) including hematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). 11. Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days. 12. Patients with imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging. 13. Positive test for HIV 14. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
  • Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen (anti-HBc) antibody test) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

Contact:

  • Oriana Nanni
  • +390543739266

Locations:

  • UO Oncologia Medica, IRST IRCCS
  • Meldola FC 47014 Italy
  • UO Oncologia Medica, C.R.O.B. - I.R.C.C.S
  • Rionero in Vulture PZ Italy
  • Ospedale Sacro Cuore "Don Calabria"
  • Negrar VR Italy
  • UO Oncologia medica, IRCCS Centro di Riferimento Oncologico di Aviano
  • Aviano Italy
  • IO Oncologia Medica, Ospedale Regionale Bolzano - Az. Sanitaria Alto Adige
  • Bolzano Italy
  • INT di Napoli Fondazione "G. Pascale"
  • Napoli Italy
  • UO Oncologia Medica, Azienda Ospedaliera-Universitaria di Parma
  • Parma Italy
  • UO Oncologia Medica, AOU PISANA - Ospedale Santa Chiara
  • Pisa Italy
  • Azienda Ospedaliera Arcispedale S. Maria Nuova/IRCCA di Reggio Emilia
  • Reggio Emilia Italy

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker ‐ Drug Exposure ‐ as a Predictor for Drug Response in Patients With mCRPC


Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Other: Abiraterone Acetate

Purpose: The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02426333

Sponsor: Radboud University

Primary Outcome Measures:

  • Measure: abiraterone AUC
  • Time Frame: 6 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: biomarkers: relation between biomarkers and treatment response
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: biomarker reduction
  • Time Frame: 6 months
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: January 2016

Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Phase: Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Eligibility:

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

Inclusion Criteria:

  • Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
  • Age ≥18 years
  • Feasible to collect blood samples from
  • Life expectancy of > 6 months
  • Measurable disease
  • Able and willing to give written informed consent prior to screening and enrollment

Exclusion Criteria:

  • other anticancer therapies
  • potent CYP3A4 inducers
  • herbal medicine that could interfere with abiraterone exposure

Contact:

  • Nielka van Erp, PharmD, PhD
  • +31243616405

Locations:

  • Jeroen Bosch Ziekenhuis
  • Den Bosch Netherlands
  • Canisius Wilhelmina Ziekenhuis
  • Nijmegen Netherlands
  • Radboud UMC
  • Nijmegen Netherlands

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER


Condition: mCRPC

Intervention:

  • Drug: Talazoparib with enzalutamide
  • Drug: Placebo with enzalutamide

Purpose: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03395197

Sponsor: Pfizer

Primary Outcome Measures:

  • Measure: Confirm the dose of Talazoparib (part 1)
  • Time Frame: Day 1 up to 28 days
  • Safety Issue:
  • Measure: Radiographic PFS (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 25 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 6 months
  • Safety Issue:
  • Measure: Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 25 months
  • Safety Issue:
  • Measure: PSA response (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 25 months
  • Safety Issue:
  • Measure: Time to PSA progression (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 25 months
  • Safety Issue:
  • Measure: Time to initiation of cytotoxic chemotherapy (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: Time to initiation of antineoplastic therapy (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: Time to first symptomatic skeletal event (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: PFS on next line of therapy (PFS2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: Opiate use for cancer pain (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: randomization up to 47 months
  • Safety Issue:
  • Measure: Incidence of adverse events (part 1 and 2)
  • Time Frame: Day 1 up to 26 months
  • Safety Issue:
  • Measure: Pharmacokinetic assessment of talazoparib (part 1)
  • Time Frame: Week 1, 5, 9, and 13
  • Safety Issue:
  • Measure: Pharmacokinetic assessment of talazoparib (part 2)
  • Time Frame: week 3, 5, 9 13, and 17
  • Safety Issue:
  • Measure: Pharmacokinetic assessment of enzalutamide (part 1)
  • Time Frame: week 1, 5, 9, and 13
  • Safety Issue:
  • Measure: Pharmacokinetic assessment of enzalutamide (part 2)
  • Time Frame: week 3, 5, 9 13, and 17
  • Safety Issue:
  • Measure: Patient-reported outcome:pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:
  • Measure: Patient-reported outcome: pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:
  • Measure: Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:
  • Measure: Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:
  • Measure: Patient-reported outcome: general health status (part2) in unselected patients and patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:
  • Measure: Patient-reported outcome: general health status (part 2) in unselected patients and patients harboring DDR deficiencies
  • Time Frame: baseline up to 47 months
  • Safety Issue:

Estimated Enrollment: 872

Study Start Date: December 18, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell or signet cell features Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4). For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1). Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening. Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan. Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:
  • Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..
  • Soft tissue disease progression as defined by RECIST 1.1.
  • Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before Day 1 (Part 1) or randomization (Part 2) for patients receiving these therapies Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Life expectancy ≥ 12 months as assessed by the investigator. Able to swallow the study drug and have no known intolerance to study drugs or excipients. Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug. Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state. Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation. Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer. Prior treatment with platinum-based chemotherapy within 6 months prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy at any time in the past. Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T (other than approved bone targeting agents and GnRH agonist/antagonist therapy), or radionuclide therapy in the 28 days prior to Day 1 (Part 1) or randomization (Part 2). Treatment with any investigational agent within 4 weeks or 5 half-lives of the drug (whichever is longer) before Day 1 (Part 1) or randomization (Part 2). Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2) unless no pain related to prostate cancer has been reported in the 28 days prior to Day 1 (Part 1) or randomization (Part 2). Current use (within 7 days prior to Day 1 (Part 1) or randomization (Part 2) or anticipated use during the study of the following medications:
  • Potential DDI with talazoparib: P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar).
  • Potential DDI with enzalutamide: strong cytochrome P450 2C8 (CYP2C8) inducers (eg, rifampin), strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin and rifapentine), moderate CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil and nafcillin), and substrates of CYP3A4 (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (eg, phenytoin), or CYP2C19 (eg, S mephenytoin) with a narrow therapeutic index. Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2). Clinically significant cardiovascular disease Significant renal dysfunction as defined by any of the following laboratory abnormalities: • Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com). Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening. Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:
  • Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).
  • Albumin <2.8 g/dL Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening). Known or suspected brain metastasis or active leptomeningeal disease. Symptomatic or impending spinal cord compression or cauda equina syndrome. History of another cancer including myelodysplastic syndrome or acute myeloid leukemia, with the exception of uncomplicated nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor Gastrointestinal disorder affecting absorption. Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study. Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product 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. History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

Contact:

  • Pfizer CT.gov Call Center
  • 1-800-718-1021

Locations:

  • Alaska Urological Institute dba Alaska Clinical Research Center
  • Anchorage Alaska 99503 United States
  • Urological Associates of Southern Arizona, PC
  • Tucson Arizona 85715 United States
  • Urological Associates of Southern Arizona, P.C.
  • Tucson Arizona 85741 United States
  • Marin Cancer Care, Inc.
  • Greenbrae California 94904 United States
  • Tower Urology
  • Los Angeles California 90048 United States
  • San Diego Clinical Trials
  • San Diego California 92120 United States
  • University of Colorado Denver CTO/CTRC
  • Aurora Colorado 80045 United States
  • University of Colorado Hospital - Anschutz Cancer Pavilion
  • Aurora Colorado 80045 United States
  • University of Colorado Hospital- Anschutz Inpatient Pavilion
  • Aurora Colorado 80045 United States
  • University of Colorado Hospital- Anschutz Outpatient Pavilion
  • Aurora Colorado 80045 United States
  • The Urology Center of Colorado
  • Denver Colorado 80211 United States
  • UroPartners LLC
  • Melrose Park Illinois 60160 United States
  • First Urology, PSC
  • Jeffersonville Indiana 47130 United States
  • First Urology, PSC
  • Louisville Kentucky 40207 United States
  • Regional Urology Oncology & Radiation Center
  • Shreveport Louisiana 71106 United States
  • Regional Urology, LLC
  • Shreveport Louisiana 71106 United States
  • Michigan Institute of Urology
  • Troy Michigan 48084 United States
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • Omaha Nebraska 68114 United States
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • Omaha Nebraska 68124 United States
  • GU Research Network/Urology Cancer Center
  • Omaha Nebraska 68130 United States
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • Omaha Nebraska 68130 United States
  • New Jersey Urology, LLC
  • Voorhees New Jersey 08043 United States
  • Premier Medical Group of the Hudson Valley PC
  • Poughkeepsie New York 12601 United States
  • Associated Medical Professionals of New York, PLLC
  • Syracuse New York 13210 United States
  • TriState urologic Services PSC Inc., dba The Urology Group
  • Cincinnati Ohio 45212 United States
  • Clinical Research Solutions
  • Middleburg Heights Ohio 44130 United States
  • Cascade View Medical Building
  • Corvallis Oregon 97330 United States
  • Good Samaritan Hospital - Corvallis
  • Corvallis Oregon 97330 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17604 United States
  • Carolina Urologic Research Center
  • Myrtle Beach South Carolina 29572 United States
  • Urology Associates P.C.
  • Nashville Tennessee 37209 United States
  • The Vanderbilt Clinic
  • Nashville Tennessee 37232 United States
  • Vanderbuilt University Medical Center, Department of Urology
  • Nashville Tennessee 37232 United States
  • Houston Metro Urology
  • Houston Texas 77027 United States
  • Farmington Health Center -University of Utah
  • Farmington Utah 84025 United States
  • University of Utah, Huntsman Cancer Hospital
  • Salt Lake City Utah 84112 United States
  • University of Utah, Huntsman Cancer Institute
  • Salt Lake City Utah 84112 United States
  • Redwood Health Center-University of Utah
  • Salt Lake City Utah 84119 United States
  • South Jordan Health Center -University of Utah
  • South Jordan Utah 84095 United States
  • Swedish Cancer Institute
  • Seattle Washington 98104 United States
  • Swedish Medical Center
  • Seattle Washington 98122 United States
  • University of Wisconsin Clinical Science Center
  • Madison Wisconsin 53792 United States
  • University of Wisconsin Hospital & Clinics
  • Madison Wisconsin 53792 United States
  • Port Macquarie Base Hospital
  • Port Macquarie New South Wales 2444 Australia
  • ICON Cancer Centre Wesley
  • Auchenflower Queensland 4066 Australia
  • River City Pharmacy
  • Auchenflower Queensland 4066 Australia
  • Princess Alexandra Hospital
  • Brisbane Queensland 4102 Australia
  • ICON Cancer Centre Chermside
  • Chermside Queensland 4032 Australia
  • ICON Cancer Centre South Brisbane
  • South Brisbane Queensland 4101 Australia
  • Integrated Clinical Oncology Network Pty Ltd (ICON)
  • South Brisbane Queensland 4101 Australia
  • ICON Cancer Centre Southport
  • Southport Queensland 4215 Australia
  • A.Z. Sint-Lucas
  • Gent 9000 Belgium
  • CHU UCL Namur site Godinne
  • Yvoir 5530 Belgium
  • HUS Helsinki University Hospital
  • Helsinki 00029 Finland
  • Docrates Cancer Center
  • Helsinki 00180 Finland
  • HUS Pharmacy, Clinical Trials
  • Helsinki 00290 Finland
  • Kuopio University Hospital
  • Kuopio 70029 Finland
  • Kuopio University Hospital
  • Kuopio 70210 Finland
  • Pirkanmaan sairaanhoitopiiri/Sairaala-apteekki/Tutkimusfarmaseutti
  • Tampere 33520 Finland
  • Tampere University Hospital
  • Tampere 33520 Finland
  • Turku University Hospital
  • Turku 20520 Finland
  • Orszagos Onkologiai Intezet
  • Budapest 1122 Hungary
  • Országos Onkológiai Intézet
  • Budapest 1122 Hungary
  • Uzoki Utcai Korhaz
  • Budapest 1145 Hungary
  • Uzsoki Utcai Kórház
  • Budapest 1145 Hungary
  • Debreceni Egyetem Klinikai Kozpont Klinikai Gyogyszertar
  • Debrecen 4032 Hungary
  • Debreceni Egyetem Klinikai Kozpont
  • Debrecen 4032 Hungary
  • Pecsi Tudomanyegyetem Klinikai Kozpont Gyogyszereszeti Intezet es Klinikai Kozponti Gyogyszertar
  • Pecs 7624 Hungary
  • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet
  • Pecs 7624 Hungary
  • Rabin Medical Center, Beilinson Hospital
  • Petah Tikva 4941492 Israel
  • ASST di Cremona
  • Cremona CR 26100 Italy
  • Nagoya University Hospital
  • Nagoya Aichi 466-8560 Japan
  • National Cancer Center Hospital East
  • Kashiwa Chiba 277-8577 Japan
  • National Hospital Organization Hokkaido Cancer Center
  • Sapporo Hokkaido 003-0804 Japan
  • Hokkaido University Hospital
  • Sapporo Hokkaido 060-8648 Japan
  • Yokohama City University Medical Center
  • Yokohama Kanagawa 232-0024 Japan
  • Yokosuka Kyosai Hospital
  • Yokosuka Kanagawa 238-8558 Japan
  • Osaka International Cancer Institute
  • Osaka-shi Osaka 5418567 Japan
  • Kindai University Hospital
  • Osakasayama Osaka 589-8511 Japan
  • Hamamatsu University School of Medicine, University Hospital
  • Hamamatsu Shizuoka 431-3192 Japan
  • National Hospital Organization Tokyo Medical Center
  • Meguro-ku Tokyo 152-8902 Japan
  • Keio University Hospital
  • Shinjuku-ku Tokyo 160-8582 Japan
  • Chiba Cancer Center
  • Chiba 260-8717 Japan
  • National Hospital Organization Kyushu Cancer Center
  • Fukuoka 811-1395 Japan
  • National Hospital Organization Kumamoto Medical Center
  • Kumamoto 860-0008 Japan
  • Tokushima University Hospital
  • Tokushima 770-8503 Japan
  • Yamagata Prefectural Central Hospital
  • Yamagata 990-2292 Japan
  • Clinical Trial Pharmacy, National Cancer Center
  • Goyang-si Gyeonggi-do 10408 Korea, Republic of
  • National Cancer Center
  • Goyang-si Gyeonggi-do 10408 Korea, Republic of
  • Pusan National University Hospital
  • Busan 49241 Korea, Republic of
  • Kyungpook National University Chilgok Hospital
  • Daegu 41404 Korea, Republic of
  • Department of Urology, Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Clinical Trial Center, Serverance Hospital, yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Severance Hospital, Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Cancer Center Clinical Trial, Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Clinical Trials Center Pharmacy
  • Seoul 06351 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • Clinical Trial Pharmacy, The Catholic University of Korea
  • Seoul 06591 Korea, Republic of
  • The Catholic University of Korea
  • Seoul 06591 Korea, Republic of
  • Tauranga Urology Research Limited
  • Tauranga BAY OF Plenty 3112 New Zealand
  • Auckland City Hospital
  • Auckland 1023 New Zealand
  • Akershus University Hospital
  • Lorenskog 1478 Norway
  • Sykehusapoteket Ahus Lorenskog
  • Norbyhagen 1474 Norway
  • Oslo University Hospital -Ullevål & Radiumhospitalet
  • Oslo 0379 Norway
  • Sykehusapoteket Oslo
  • Oslo 0379 Norway
  • St. Olavs Hospital, Trondheim University Hospital
  • Trondheim 7030 Norway
  • Sykehusapoteket i Trondheim
  • Trondheim 7030 Norway
  • Szpital Specjalistczny W Brzozowie Podkarpack I Osrodek Onkologiczny im. Ks. B Markiewicza
  • Brzozow 36-200 Poland
  • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
  • Gdynia 81-519 Poland
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina
  • Otwock 05-400 Poland
  • NZOZ Szpital Mazovia; Oddzial urologiczny
  • Warszawa 02-797 Poland
  • Hospital Clinico Universitario de Santiago de Compostela
  • Santiago de Compostela A Coruna 15706 Spain
  • Hospital General Universitario de Elche
  • Elche Alicante 03203 Spain
  • Hospital Universitari Vall d'Hebron
  • Barcelona 08035 Spain
  • Hospital Universitario 12 De Octubre
  • Madrid 28041 Spain
  • Royal Cornwall Hospitals NHS Trust
  • Cornwall TR1 3LJ United Kingdom
  • NHS Greater Glasgow and Clyde (Radiology/Scans Address)
  • Glasgow G12 0YN United Kingdom
  • NHS Greater Glasgow and Clyde, The Beatson West of Scotland Cancer Centre
  • Glasgow G12 0YN United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.


Condition: Advanced Prostate Cancer, Castration Resistant, Enzalutamide

Purpose: PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02922218

Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III

Primary Outcome Measures:

  • Measure: To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
  • Time Frame: Initially 48 months, currently 60 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.
  • Time Frame: Initially 48 months, currently 60 months
  • Safety Issue:
  • Measure: To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
  • Time Frame: Initially 48 months, currently 60 months
  • Safety Issue:
  • Measure: To explore the correlation between AR-V7 expression and AR amplification with other biomarkers as testosterone serum levels, PTEN loss or TMPRSS-ERG fusions in mCRPC patients treated with Enzalutamide
  • Time Frame: Initially 48 months, currently 60 months
  • Safety Issue:
  • Measure: To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients
  • Time Frame: Initially 48 months, currently 60 months
  • Safety Issue:

Estimated Enrollment: 187

Study Start Date: June 2016

Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Phase: Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Eligibility:

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

Inclusion Criteria:

  1. Male age ≥ 18 years
  2. Histologically confirmed adenocarcinome of the prostate
  3. ECOG Performance Status ≤ 2
  4. Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
  5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
  6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
  7. Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours.
  8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
  9. Acceptable hematological, hepatic and renal functions.

Exclusion Criteria:

  1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
  2. 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:

  • David Olmos, MD
  • 34 91 732 8000 Ext. 2950

Locations:

  • Hospital Arquitecto Marcide
  • Ferrol A Coruña 15405 Spain
  • Hospital Universitario de Santiago
  • Santiago de Compostela A Coruña 15706 Spain
  • ICO L'Hospitalet
  • L'Hospitalet de Llobregat Barcelona 08907 Spain
  • Hospital Althaia Manresa
  • Manresa Barcelona 08243 Spain
  • Hospital de Especialidades de Jerez de la Frontera
  • Jerez de la Frontera Cádiz 11407 Spain
  • Hospital Costa del Sol
  • Marbella Málaga 29603 Spain
  • Complejo Hospitalario de Navarra
  • Pamplona Navarra 31008 Spain
  • Hospital Universitario de Canarias
  • La Laguna Tenerife 38320 Spain
  • Fundacion Centro Oncologico de Galicia
  • A Coruna 15009 Spain
  • Hospital Universitario Vall D'Hebron
  • Barcelona 08035 Spain
  • Hospital de Burgos
  • Burgos 09006 Spain
  • Hospital de Ciudad Real
  • Ciudad Real 13005 Spain
  • Hospital Universitario Reina Sofia
  • Cordoba 14004 Spain
  • Hospital Universitario Virgen de las Nieves
  • Granada 18014 Spain
  • Hospital Universitario de Guadalajara
  • Guadalajara 19002 Spain
  • Hospital Universitario Gregorio Maranon
  • Madrid 28007 Spain
  • Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
  • Madrid 28029 Spain
  • Hospital Universitario Clinico San Carlos
  • Madrid 28040 Spain
  • Hospital Universitario 12 de Octubre
  • Madrid 28041 Spain
  • Centro Integral Oncologico Clara Campal
  • Madrid 28050 Spain
  • Hospital Regional Universitario Virgen de la Victoria
  • Malaga 29010 Spain
  • Hospital Morales Messeguer
  • Murcia 30008 Spain
  • Hospital Virgen de la Victoria
  • Málaga 29010 Spain
  • Hospital Son Espases
  • Palma de Mallorca 07120 Spain
  • Complejo Hospitalario de Pontevedra
  • Pontevedra 36002 Spain
  • Hospital Universitario La Fe
  • Valencia 46026 Spain

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)


Condition: Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

Intervention:

  • Drug: Enzalutamide
  • Drug: Indomethacin

Purpose: This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones, has come back, or has spread from where it started to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02935205

Sponsor: University of California, Davis

Primary Outcome Measures:

  • Measure: Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
  • Time Frame: Up to 3.5 years
  • Safety Issue:
  • Measure: PSA response rate defined as >= 50% decrease from the baseline
  • Time Frame: Up to 3.5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall response determined by PCWG2 criteria
  • Time Frame: Up to 3.5 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Up to 3.5 years
  • Safety Issue:
  • Measure: PFS
  • Time Frame: Up to 3.5 years
  • Safety Issue:

Estimated Enrollment: 38

Study Start Date: January 17, 2017

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 19 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed prostate cancer (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP
  • Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):
  • Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug
  • Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)
  • Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
  • Measurable disease is not required
  • Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug
  • Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
  • Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
  • If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher
  • Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
  • Creatinine =< 1.5 x institutional upper limit of normal
  • 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 of enzalutamide administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who are receiving any other investigational agents within the preceding 4 weeks
  • Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
  • Patient has received enzalutamide or ketoconazole for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, abiraterone, flutamide, and nilutamide) or chemotherapy (docetaxel, cabazitaxel, or mitoxantrone) is allowed
  • Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers
  • 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
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or indomethacin
  • Uncontrolled intercurrent 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
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patients with an active bleeding diathesis
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
  • Patients with a history of seizure disorder, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation
  • Patients with a history of peptic ulcer disease or gastrointestinal bleeding

Location:

  • University of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy


Condition: Prostate Cancer

Intervention:

  • Radiation: Brachytherapy
  • Other: Hyperthermia

Purpose: Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03238066

Sponsor: University of Erlangen-Nürnberg Medical School

Primary Outcome Measures:

  • Measure: Rate of late GI/GU grade 3 and more toxicities
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Rate of acute GI/GU treatment-related adverse events
  • Time Frame: up to 24 months after start of recruitment
  • Safety Issue:
  • Measure: Time to biochemical failure
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Disease-free survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Disease-specific survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Clinical patterns of tumor recurrence
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:

Estimated Enrollment: 77

Study Start Date: April 2015

Eligibility:

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

Inclusion Criteria:

  • Histologically-confirmed locally recurrent prostate cancer
  • biopsy performed < 6 months before registration;
  • Histology: Adenocarcinoma, every Gleason score (2-10)
  • Initial treatment (EBRT) completed > 24 months prior to biopsy;
  • Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration
  • Staging performed within 12 weeks prior to registration:
  • Local stage evaluated by DRE, TRUS or
  • if necessary
  • mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);
  • Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);
  • Negative bone scan (M0);
  • PSA-DT > 6 months (PSA measurements taken of the 12 months prior to registration)
  • Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) < 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;
  • Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:
  • Prostate/tumor volume <60ml
  • The distance rear prostate edge
  • rectal mucosa >5mm
  • Interference of pubic arch ruled out
  • If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration
  • Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)
  • The patient is suitable for spinal or general anesthesia
  • Age > 18 y.
  • Life expectancy > 5 years
  • absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • The patient must sign a study-specific informed consent form before study registration

Exclusion Criteria:

  • Severe, active comorbidities:
  • Decompensated congestive heart disease
  • Chronic obstructive pulmonary disease exacerbation, respiratory failure
  • Hepatic insufficiency resulting in coagulation defects or clinical jaundice
  • Other active malignancy or treatment of invasive or hematological malignancy
  • Evidence of extraprostatic disease at local recurrence:
  • Local stage T4
  • Histologic or radiologic evidence of lymph node metastases (N1 or pN1)
  • Presence of distant metastases (M1)
  • Any of the following prior therapies:
  • TURP within 6 months prior to registration
  • Prostatic salvage cryosurgery performed at least 6 months before registration
  • HIFU performed at least 6 months before registration
  • Androgen deprivation therapy within 3 months prior to registration
  • Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Contact:

  • Vratislav Strnad, MD
  • ++49(0)9131-85 Ext. 33419

Locations:

  • Strahlenklinik im Universitaetsklinikum Erlangen
  • Erlangen 91054 Germany
  • Centrum Radiotherapii
  • Kraków 31-826 Poland
  • Maria Sklodowska-Curie Institute - Oncology Center
  • Warszaw 02-034 Poland

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study


Condition: Hormone-Resistant Prostate Cancer, Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention:

  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Purpose: This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03122743

Sponsor: Wake Forest University Health Sciences

Primary Outcome Measures:

  • Measure: Change in distress score, assessed by the Distress Thermometer
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in serum cortisol levels
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Change in serum epinephrine levels
  • Time Frame: Up to 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Change in levels of distress assessed by the Distress Thermometer
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in serum cortisol levels
  • Time Frame: Baseline up to 1 year
  • Safety Issue:
  • Measure: Change in serum epinephrine levels
  • Time Frame: Baseline up to 1 year
  • Safety Issue:

Estimated Enrollment: 60

Study Start Date: February 20, 2017

Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Phase: Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Eligibility:

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

Inclusion Criteria:

  • A confirmed diagnosis of prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
  • Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

  • History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators

Location:

  • Comprehensive Cancer Center of Wake Forest University
  • Winston-Salem North Carolina 27157 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.


Condition: Carcinoma Prostate

Intervention:

  • Drug: Xtandi

Purpose: Open label, single arm, phase II multicentre study designed to determine the clinical benefit, as measured by 3-months disease control rate (DCR) provided by enzalutamide in metastatic Castration Resistant Prostate Cancer patients with at least one visceral site involvement.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03103724

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Primary Outcome Measures:

  • Measure: Disease Control Rate (DCR)
  • Time Frame: 3 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Safety of the treatment per NCI-CTCA v. 4.0
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Quality of life by EQ-5D-5L e FACT-P
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Pain assessment
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 68

Study Start Date: March 16, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Age > 18 2. ECOG PS 0-1-2 3. Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma 4. Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria) considering metastases in lung or liver or extraregional lymphnodes 5. Written informed consent 6. Platelets > or = 100 x109/L; haemoglobin > or = 9 g/dl; neutrophils > or 1.5 x 109/L 7. Bilirubin < or = 2 mg/dl, AST and ALT < or = 2.5 times the UNL or < or = 5 times UNL for pts with liver metastases; serum albumin > or = the LNL 8. Patients of childbearing age should use contraceptive methods 9. Life expectancy > 3 months 10. Able to swallow the study drug and comply with study requirements; 11. Willing and able to give informed consent. 12. Ongoing androgen deprivation therapy with a GnRH analogue or orchiectomy (i.e., surgical or medical castration); 13. Patients may have received previous therapy including chemotherapy (docetaxel) last cycle must be received 3 weeks before start of experimental treatment. Hormonal treatment containing bicalutamide must be interrupted 2 weeks before start of study therapy 14. Previous radiotherapy (prostate and/or bone) is accepted but must be interrupted 3 weeks before start of experimental treatment. 15. Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit 16. Progressive disease by PSA or imaging in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria (according with PCWG2):
  • PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 g/L (2 ng/ml); if the third PSA value is less than second PSA, a fourth PSA must be repeated and if it the value is higher than second must be considered as disease
  • Soft tissue/visceral disease progression defined by RECIST 1.1;
  • Bone disease progression defined by two or more new lesions on bone scan.

Exclusion Criteria:

  1. Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
  2. Metastases in the brain or active epidural disease;
  3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer;
  4. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months of enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, head trauma with loss of consciousness requiring hospitalization);
  5. 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 a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%;
  6. Diagnosed or suspected congenital long QT syndrome;
  7. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  8. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer within last 3 months);
  9. Major surgery within 4 weeks prior to enrollment (Day 1 visit);
  10. Prior treatment with abiraterone acetate;
  11. Participation in a clinical trial about an experimental anti-androgen agent (eg. ARN-509, ODM-201, VT-464, except for placebo arm);
  12. Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride).

Contact:

  • Elena Verzoni, MD
  • +390223904449

Location:

  • Elena Verzoni
  • Milan 20133 Italy

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer


Condition: Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence

Intervention:

  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: high-intensity focused ultrasound ablation
  • Procedure: multiparametric magnetic resonance imaging
  • Procedure: quality-of-life assessment
  • Procedure: transperineal prostate biopsy
  • Procedure: transrectal prostate biopsy

Purpose: RATIONALE: Prospective trials using hemi-ablation with high intensity focused ultrasound (HIFU) (Sonablate 500) have demonstrated feasibility, safety, and encouraging functional outcomes and early cancer control with 90% of men achieving trifecta status (no erectile dysfunction, leak-free pad-free continence, cancer control). However, these trials have involved small numbers of patients with men selected for good baseline function. A multi-centre prospective trial within a larger cohort of men that better represents the patient population with prostate cancer (external validity) is required.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01194648

Sponsor: University College, London

Primary Outcome Measures:

  • Measure: Conversion to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Conversion to radical therapy and/or requiring systemic therapy and/or developing metastases and/or dying of prostate cancer
  • Time Frame: 10 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: rate of erectile dysfunction
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: rate of erectile dysfunction
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: time to return of erectile function
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of urinary incontinence (pad free, leak free and pad-free alone)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: rate of urinary incontinence (pad free, leak free and pad-free alone)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: time to return of continence (pad free, leak free and pad-free alone)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of loss of ejaculation
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of loss of orgasm
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of pain during intercourse
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: number of men using phosphodiesterase-5 inhibitors to maintain erectile function
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of lower urinary tract symptoms
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of bowel toxicity
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: anxiety levels
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: general health related quality of life
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: proportion of men achieving trifecta status at 12 months
  • Time Frame: 12months
  • Safety Issue:
  • Measure: proportion of men achieving trifecta status at 24 months
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation, whole-gland HIFU or cryosurgery)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: risk factors for failure defined as a) presence of any cancer and b) clinically significant cancer at study end
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: biochemical (PSA) kinetics including determining the optimal biochemical definition of failure
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: describe composite outcomes of failure
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Cost-effectiveness
  • Time Frame: 5years
  • Safety Issue:
  • Measure: Cost-effectiveness
  • Time Frame: 10 years
  • Safety Issue:

Estimated Enrollment: 354

Study Start Date: June 29, 2011

Eligibility:

  • Age: minimum N/A maximum 90 Years
  • Gender: Male

Criteria: 1. Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies. 2. Prostate biopsy (either TRUS or MRI Targeted or Template): - TRUS biopsy: up to burden bilateral disease with maximum 3mm one biopsy on non-dominant side is allowable. - MRI targeted and/or Template biopsy within 12 months of entry showing: - unilateral disease minimum 3mm of Gleason 3+3 or any Gleason 3+4 or 4+3 but not exceeding Gleason 4+3 overall OR - bilateral disease presence of clinically significant cancer on only one side (as determined by histological rules described above) Gleason ≤7 which is concordant with the MRI findings. 3. Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted). 4. Serum PSA /=10 years. 6. Signed informed consent by patient. 7. An understanding of the English language sufficient to understand

Location:

  • University College London
  • London England WC1E 6BT United Kingdom

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)


Condition: Prostate Cancer, Localized Malignant Neoplasm

Intervention:

  • Radiation: Stereotactic Body Radiation Therapy (SBRT)

Purpose: Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01766492

Sponsor: Georgetown University

Primary Outcome Measures:

  • Measure: fatigue
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: urinary symptoms
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: bowel symptoms
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: sexual function
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: cancer control
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: toxicity symptoms
  • Time Frame: 24 months
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: December 2012

Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Phase: Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of prostate
  • Signed study-specific consent
  • Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Prior radical prostate surgery
  • Medical or psychiatric illness that would interfere with treatment or follow up
  • Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

Contact:

  • Malika T Danner
  • 202-444-3068

Location:

  • Georgetown University Hospital
  • Washington District of Columbia 20007 United States

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial


Condition: Prostate Cancer

Intervention:

  • Drug: 68Ga- PSMA-HBED-CC
  • Device: Biograph mMR, Siemens

Purpose: This diagnostic clinical trial will be conducted according to a randomized, prospective, controlled, double-arm, single-centre design. The control will be implemented by comparing the PET/MRI results with the histopathological finding after radical prostatectomy (positive state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and standard biopsy are negative (negative state) and/or the detection of a biochemical tumor relapse (rising PSA after PSA nadir; secondary objective).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02659527

Sponsor: Medical University of Vienna

Primary Outcome Measures:

  • Measure: Superiority of image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI
  • Time Frame: 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: tumor characterization
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: early biochemical relapse
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 220

Study Start Date: January 2016

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • blood PSA level > 4.0 ng/ml and
  • free-to-total PSA ratio <22% and/or
  • progressive rise of PSA levels in two consecutive blood samples despite antibiotics

Exclusion Criteria:

  • antiandrogen therapy
  • prostate needle biopsy <21 days before PET/MRI
  • known active secondary cancer
  • endorectal coil not applicable (e.g. anus praetor with short rectal stump)
  • known active prostatitis (e.g. painful DRE)
  • known anaphylaxis against gadolinium-DOTA
  • patient's written informed consent not given
  • needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry

Contact:

  • Markus Hartenbach, Ass.Prof.Dr.med.
  • 00431 40400 Ext. 73412

Location:

  • Department of Biomedical Imaging and Image-guided Therapy
  • Vienna 1090 Austria

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe