Prostate Cancer

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Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors


Condition: Prostatic Neoplasm

Intervention:

  • Behavioral: Restore Rehabilitation Program
  • Behavioral: Control

Purpose: Development and evaluation of an online intervention addressing sexual functioning in MSM after prostate cancer treatment.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03343093

Sponsor: University of Minnesota, MN

Primary Outcome Measures:

  • Measure: Urinary Incontinence
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Erectile Dysfunction
  • Time Frame: 24 months
  • Safety Issue:

Estimated Enrollment: 450

Study Start Date: January 1, 2019

Eligibility:

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

Inclusion Criteria:

  1. . Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man.
  2. . Treated for prostate cancer, defined as (i) having been diagnosed with prostate cancer and measured by being able to report a Prostate- Specific Antigen and Gleason score; and (ii) treated by radical prostatectomy, radiation or systemically.
  3. . Has recent problems with sexual and/or urinary function, by self-report. This is measured by a screener item(s) asking the enrollee to describe their current function (last 4 weeks) and validated by nurse interview.
  4. . Internet-using
  5. . Living in the US (including territories) as measured by valid US zip code
  6. . A unique, validated individual, as measured by our published de-duplication and cross-validation protocols,230-232 and confirmed by video or phone interview.

Exclusion Criteria:

  1. . No Nerve Sparing and Salvage therapy.
  2. . Medical contraindications as determined by investigators at screening
  3. . Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days)
  4. .Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days
  5. . Participation is limited to English speakers/readers since intervention materials and surveys are in English.
  6. . Cognitive impairment.

Contact:

  • Chris J Hoefer
  • 612-625-4799

Location:

  • University of Minnesota Twin Cities Campus
  • Minneapolis Minnesota 55454 United States

View trial on ClinicalTrials.gov


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Docetaxel and Prostvac for Metastatic Castration Sensitive Prostate Cancer


Condition: Prostate Cancer, Prostate Neoplasms, Neoplasms, Prostatic

Intervention:

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

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02649855

Sponsor: National Cancer Institute (NCI)

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 74

Study Start Date: January 19, 2016

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Contact:

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

Location:

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

View trial on ClinicalTrials.gov


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


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

Intervention:

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

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03419234

Sponsor: ECOG-ACRIN Cancer Research Group

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 210

Study Start Date: February 8, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Eligibility Criteria:

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

Exclusion Criteria:

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

Locations:

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

View trial on ClinicalTrials.gov


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


Condition: Prostate Cancer, Bone Metastases

Intervention:

  • Drug: Zoledronic Acid
  • Drug: Enzalutamide

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03336983

Sponsor: Azienda Ospedaliera Spedali Civili di Brescia

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 120

Study Start Date: December 1, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Contact:

  • Alfredo Berruti, MD
  • 030399 Ext. 5410

Location:

  • Azienda Ospedaliera Spedali Civili di Brescia
  • Brescia 25123 Italy

View trial on ClinicalTrials.gov


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


Condition: Prostate Adenocarcinoma

Intervention:

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

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03361735

Sponsor: City of Hope Medical Center

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 24

Study Start Date: August 29, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Contact:

  • Savita Dandapani, MD
  • 626 256-4673

Location:

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

View trial on ClinicalTrials.gov


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


Condition: Metastatic Hormone-Sensitive Prostate Cancer

Intervention:

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

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03532217

Sponsor: Washington University School of Medicine

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 20

Study Start Date: September 14, 2018

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Contact:

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

Locations:

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

View trial on ClinicalTrials.gov


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


Condition: Prostate Cancer

Intervention:

  • Other: No intervention

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

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03619980

Sponsor: Astellas Pharma Europe Ltd.

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment: 1869

Study Start Date: September 13, 2018

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Eligibility:

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

Inclusion Criteria:

  • All patients registered in PPC.

Exclusion Criteria:

    Location:

    • Site SE46001
    • Uppsala 753 09 Sweden

    View trial on ClinicalTrials.gov


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


    Condition: Prostate Cancer, Adenocarcinoma of the Prostate

    Intervention:

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

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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03689699

    Sponsor: Charles G. Drake

    Primary Outcome Measures:

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

    Secondary Outcome Measures:

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

    Estimated Enrollment: 60

    Study Start Date: March 2019

    Phase: Phase 1/Phase 2

    Eligibility:

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

    Inclusion Criteria:

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

    Exclusion Criteria:

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

    Contact:

    • Ana Oliveira Serra
    • 212-342-0248

    Locations:

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

    View trial on ClinicalTrials.gov


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


    Condition: Metastatic Hormone-sensitive Prostate Cancer

    Intervention:

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

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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03879122

    Sponsor: Spanish Oncology Genito-Urinary Group

    Primary Outcome Measures:

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

    Secondary Outcome Measures:

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

    Estimated Enrollment: 135

    Study Start Date: February 11, 2019

    Phase: Phase 2/Phase 3

    Eligibility:

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

    Inclusion Criteria:

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

    Exclusion Criteria:

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

    Contact:

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

    Locations:

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

    View trial on ClinicalTrials.gov


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    A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)


    Condition: Metastatic Castration-resistant Prostate Cancer

    Intervention:

    • Drug: olaparib
    • Drug: abiraterone acetate

    Purpose: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03732820

    Sponsor: AstraZeneca

    Primary Outcome Measures:

    • Measure: Radiological progression free survival (rPFS)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Time to first subsequent anticancer therapy or death (TFST)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Time to pain progression (TTPP)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Time to opiate use
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Time to a Symptomatic Skeletal-Related Event (SSRE)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Circulating Tumour Cells (CTC) conversion
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Time to second progression or death (PFS2)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Brief Pain Inventory-Short Form (BPI-SF)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
    • Time Frame: From date of randomization to study completion (up to 4 years)
    • Safety Issue:
    • Measure: Homologous Recombination Repair (HRR) gene status
    • Time Frame: At baseline
    • Safety Issue:
    • Measure: Maximum plasma concentration at steady state [Cmax,ss]
    • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
    • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Minimum plasma concentration at steady state [Cmin,ss]
    • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Partial area under the concentration-time curve in 0-8 h [AUC0-8])
    • Time Frame: Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Maximum plasma concentration at steady state [Cmax,ss]
    • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
    • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Minimum plasma concentration at steady state [Cmin,ss]
    • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Partial area under the concentration-time curve [AUC0-8])
    • Time Frame: Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
    • Safety Issue:
    • Measure: Number of adverse events
    • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
    • Safety Issue:
    • Measure: Vital signs-blood pressure
    • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
    • Safety Issue:
    • Measure: Vital signs-pulse rate
    • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
    • Safety Issue:
    • Measure: Vital signs-body temperature
    • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
    • Safety Issue:
    • Measure: ECG
    • Time Frame: From the time of signature of informed consent throughout the treatment period (up to 4 years)
    • Safety Issue:
    • Measure: Change in Albumin (g/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Alkaline phosphatase (U/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Aspartate aminotransferase (U/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Amylase (U/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Alanine aminotransferase (U/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Total bilirubin (μmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Direct bilirubin
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Calcium (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Chloride (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Creatinine (μmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Gamma glutamyltransferase (U/L)
    • Time Frame: At screening only
    • Safety Issue:
    • Measure: Change in Fasting gucose (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Lactate dehydrogenase (U/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Magnesium (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Potassium (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Phosphorus ((mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Sodium (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Carbon dioxide (mEq/L )
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Total protein (g/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in absolute neutrophil count (/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in absolute lymphocyte count (/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in haemoglobin (g/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in platelet count with differential (/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in total white blood cell count with differential(/L)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in red blood cell count (/l)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Haematocrit (%)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Change in Mean Cell Volume (fL)
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Urinalysis:change in blood
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Urinalysis: Change in protein
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:
    • Measure: Urinalysis: change in glucose
    • Time Frame: At scheduled visits from screening to 30 days after last dose of study medication
    • Safety Issue:

    Estimated Enrollment: 720

    Study Start Date: October 31, 2018

    Phase: Phase 3

    Eligibility:

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

    Inclusion Criteria:

    • 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:
    • Provision of informed consent for genetic research prior to collection of sample.
    • Provision of informed consent for biomarker research prior to collection of sample. If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study. 4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative. 5. Histologically or cytologically confirmed prostate adenocarcinoma. 6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan. 7. First-line metastatic castration-resistant prostate cancer (mCRPC). 8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study. 9. Candidate for abiraterone therapy with documented evidence of progressive disease. 10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks. 12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study. 14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

    Exclusion Criteria:

    1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.
    2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
    3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan.
    4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
    5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).
    6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).
    7. History of uncontrolled pituitary or adrenal dysfunction.
    8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.
    9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.
    10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
    11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia.
    12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required.
    13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks.
    14. Patients who are unevaluable for both bone and soft tissue progression
    15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    16. Immunocompromised patients
    17. Patients with known active hepatitis infection (ie, hepatitis B or C).
    18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.
    19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.
    20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).
    21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
    22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents.
    23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
    25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.
    26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone.
    27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).
    28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
    29. Previous randomisation in the present study.

    Contact:

    • AstraZeneca Clinical Study Information Center
    • 1-877-240-9479

    Locations:

    • Research Site
    • Homewood Alabama 35209 United States
    • Research Site
    • Anchorage Alaska 99503 United States
    • Research Site
    • Tucson Arizona 85704 United States
    • Research Site
    • Tucson Arizona 85741 United States
    • Research Site
    • Clovis California 93611 United States
    • Research Site
    • La Jolla California 92037 United States
    • Research Site
    • Los Angeles California 90027 United States
    • Research Site
    • Los Angeles California 90073 United States
    • Research Site
    • Sacramento California 95817 United States
    • Research Site
    • San Diego California 92123 United States
    • Research Site
    • Norwich Connecticut 06360 United States
    • Research Site
    • Lisle Illinois 60532 United States
    • Research Site
    • Jeffersonville Indiana 47130 United States
    • Research Site
    • New Orleans Louisiana 70112 United States
    • Research Site
    • Towson Maryland 21204 United States
    • Research Site
    • Detroit Michigan 48202 United States
    • Research Site
    • Grand Rapids Michigan 49503 United States
    • Research Site
    • Saint Louis Missouri 63016 United States
    • Research Site
    • Bozeman Montana 59715 United States
    • Research Site
    • Omaha Nebraska 68130 United States
    • Research Site
    • Paramus New Jersey 07652 United States
    • Research Site
    • Brooklyn New York 11220 United States
    • Research Site
    • Fresh Meadows New York 11366 United States
    • Research Site
    • Lake Success New York 11042 United States
    • Research Site
    • Mineola New York 11501 United States
    • Research Site
    • Rochester New York 14642 United States
    • Research Site
    • Syracuse New York 13210 United States
    • Research Site
    • White Plains New York 10601 United States
    • Research Site
    • Durham North Carolina 27710 United States
    • Research Site
    • Middleburg Heights Ohio 44130 United States
    • Research Site
    • Portland Oregon 97239 United States
    • Research Site
    • Philadelphia Pennsylvania 19111 United States
    • Research Site
    • Charleston South Carolina 29425 United States
    • Research Site
    • Myrtle Beach South Carolina 29572 United States
    • Research Site
    • San Antonio Texas 78229 United States
    • Research Site
    • Seattle Washington 98109 United States
    • Research Site
    • Wheeling West Virginia 26041 United States
    • Research Site
    • Milwaukee Wisconsin 53149 United States
    • Research Site
    • Box Hill 3128 Australia
    • Research Site
    • Darlinghurst 2010 Australia
    • Research Site
    • Greenslopes 4120 Australia
    • Research Site
    • Herston 4029 Australia
    • Research Site
    • Kingswood 2747 Australia
    • Research Site
    • Kurralta Park 5037 Australia
    • Research Site
    • St Albans 3021 Australia
    • Research Site
    • Waratah 2298 Australia
    • Research Site
    • Brussels 1000 Belgium
    • Research Site
    • Brussels 1090 Belgium
    • Research Site
    • Gent 9000 Belgium
    • Research Site
    • Liège 4000 Belgium
    • Research Site
    • Curitiba 80810-050 Brazil
    • Research Site
    • Porto Alegre 90610-000 Brazil
    • Research Site
    • Porto Alegre 91350-200 Brazil
    • Research Site
    • Rio de Janeiro 22793-080 Brazil
    • Research Site
    • São José do Rio Preto 15090-000 Brazil
    • Research Site
    • Calgary Alberta T2V 1P9 Canada
    • Research Site
    • Edmonton Alberta T6G 1Z2 Canada
    • Research Site
    • Kelowna British Columbia V1Y 5L3 Canada
    • Research Site
    • Toronto CA M5G 2M9 Canada
    • Research Site
    • Halifax Nova Scotia B3H 1V7 Canada
    • Research Site
    • London Ontario N6A 5W9 Canada
    • Research Site
    • Toronto Ontario M4N 3M5 Canada
    • Research Site
    • Greenfield Park Quebec J4V 2H1 Canada
    • Research Site
    • Montreal Quebec H2X 3E4 Canada
    • Research Site
    • Montreal Quebec H3T 1E2 Canada
    • Research Site
    • Santiago 7500787 Chile
    • Research Site
    • Santiago 7520349 Chile
    • Research Site
    • Temuco 4781156 Chile
    • Research Site
    • Vina del MAr 2540364 Chile
    • Research Site
    • Beijing 100034 China
    • Research Site
    • Beijing 100050 China
    • Research Site
    • Beijing 100191 China
    • Research Site
    • Beijing 100730 China
    • Research Site
    • Changsha 410008 China
    • Research Site
    • Changsha 410013 China
    • Research Site
    • Chengdu 610041 China
    • Research Site
    • ChongQing 400038 China
    • Research Site
    • Hangzhou 310009 China
    • Research Site
    • Hangzhou 310014 China
    • Research Site
    • Hangzhou 310022 China
    • Research Site
    • Nanjing 2100008 China
    • Research Site
    • Shanghai 200025 China
    • Research Site
    • Shanghai 200032 China
    • Research Site
    • Shanghai 200040 China
    • Research Site
    • Shanghai 200127 China
    • Research Site
    • Xi'an 710061 China
    • Research Site
    • Xiamen 361003 China
    • Research Site
    • Brno 656 53 Czechia
    • Research Site
    • Hradec Kralove 500 05 Czechia
    • Research Site
    • Praha 120 00 Czechia
    • Research Site
    • Angers Cedex 01 49033 France
    • Research Site
    • BESANCON Cedex 25030 France
    • Research Site
    • Caen 14076 France
    • Research Site
    • Marseille 13003 France
    • Research Site
    • Pierre Benite 69495 France
    • Research Site
    • Bergisch Gladbach 51465 Germany
    • Research Site
    • Bremen 28277 Germany
    • Research Site
    • Duisburg 47179 Germany
    • Research Site
    • Freiburg im Breisgau 79106 Germany
    • Research Site
    • Hannover 30625 Germany
    • Research Site
    • Heinsberg 52525 Germany
    • Research Site
    • Köln 50968 Germany
    • Research Site
    • Mettmann 40822 Germany
    • Research Site
    • Nürnberg 90419 Germany
    • Research Site
    • Nürtingen 72622 Germany
    • Research Site
    • Ulm 89081 Germany
    • Research Site
    • Milano 20133 Italy
    • Research Site
    • Milano 20141 Italy
    • Research Site
    • Napoli 80131 Italy
    • Research Site
    • Orbassano 10043 Italy
    • Research Site
    • Roma 00152 Italy
    • Research Site
    • Bunkyo-ku 113-8431 Japan
    • Research Site
    • Kashihara-shi 634-8522 Japan
    • Research Site
    • Kawagoe-shi 350-8550 Japan
    • Research Site
    • Kita-gun 761-0793 Japan
    • Research Site
    • Kyoto-shi 606-8507 Japan
    • Research Site
    • Maebashi-shi 371-8811 Japan
    • Research Site
    • Nagoya-shi 466-8560 Japan
    • Research Site
    • Osaka-shi 541-8567 Japan
    • Research Site
    • Osaka-shi 545-0051 Japan
    • Research Site
    • Osakasayama-shi 589-8511 Japan
    • Research Site
    • Sagamihara-shi 252-0375 Japan
    • Research Site
    • Sakura-shi 285-8741 Japan
    • Research Site
    • Shinjuku-ku 160-8582 Japan
    • Research Site
    • Yokohama-shi 232-0024 Japan
    • Research Site
    • Goyang-si 10408 Korea, Republic of
    • Research Site
    • Seoul 03722 Korea, Republic of
    • Research Site
    • Seoul 05505 Korea, Republic of
    • Research Site
    • Seoul 06591 Korea, Republic of
    • Research Site
    • Hilversum 1213 XZ Netherlands
    • Research Site
    • Nijmegen 6525 GA Netherlands
    • Research Site
    • Tilburg 5042 AD Netherlands
    • Research Site
    • Bratislava 851 05 Slovakia
    • Research Site
    • Presov 08001 Slovakia
    • Research Site
    • Sala 92701 Slovakia
    • Research Site
    • Barcelona 08035 Spain
    • Research Site
    • Barcelona 08036 Spain
    • Research Site
    • Gerona 17007 Spain
    • Research Site
    • Madrid 28041 Spain
    • Research Site
    • Malaga 29010 Spain
    • Research Site
    • Sevilla 41009 Spain
    • Research Site
    • Adana Turkey
    • Research Site
    • Ankara 06590 Turkey
    • Research Site
    • Ankara 06800 Turkey
    • Research Site
    • Istanbul 34030 Turkey
    • Research Site
    • Izmir 35360 Turkey
    • Research Site
    • Karsiyaka 35575 Turkey
    • Research Site
    • Guildford GU2 5XX United Kingdom
    • Research Site
    • Manchester M20 4BX United Kingdom
    • Research Site
    • Sheffield S10 2SJ United Kingdom
    • Research Site
    • Southampton SO16 6YD United Kingdom
    • Research Site
    • Swansea SA2 8QA United Kingdom

    View trial on ClinicalTrials.gov


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    A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue


    Condition: Neoplasms of the Prostate

    Intervention:

    • Device: AuroShell particle infusion

    Purpose: To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02680535

    Sponsor: Nanospectra Biosciences, Inc.

    Primary Outcome Measures:

    • Measure: Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment.
    • Time Frame: Three Months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Adverse Events
    • Time Frame: Start to Three Months
    • Safety Issue:
    • Measure: Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy one year after treatment.
    • Time Frame: One Year
    • Safety Issue:

    Estimated Enrollment: 45

    Study Start Date: February 2016

    Eligibility:

    • Age: minimum 45 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients must have documented histological or cytological evidence of tumor(s) of the prostate.
    • Patients must be ≥ 45 years of age
    • Patients or their legal representative must be able to read, understand and sign an informed consent
    • Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging
    • Prostate cancer is diagnosed by MR image guided biopsies
    • Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.
    • If the standard biopsy cores are positive, they must be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (Left / Right, Base, Mid Gland, Apex).
    • Prior MRI results dated within 120 days prior to ablation.
    • No metastatic disease as per NCCN guidelines (www.nccn.org)
    • Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10
    • PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml
    • The patient has given written informed consent after the nature of the study and alternative treatment options have been explained

    Exclusion Criteria:

    • Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold)
    • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
    • Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing
    • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
    • The presence of 3 or more MR Visible lesions positive on biopsy.
    • The presence of extra capsular, seminal vesicle invasion or metastatic disease.
    • Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc…)
    • Patient with inability to follow up.
    • History of prior treatment for prostate cancer.
    • Acute urinary tract infection.
    • Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) > 20
    • Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, due to they will not be able to undergo gadolinium enhance MRI.
    • Patients with acute or chronic hepatic dysfunction as evidenced by clinically significant abnormalities in albumin, total protein, or prothrombin time, or evidence of hepatic injury with clinically important (> grade 1) changes in AST, ALT, ALP, bilirubin, or GGT values.
    • Patients with uncontrolled coagulopathies who are at increased risk of bleeding.
    • Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes.
    • Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.

    Locations:

    • Johns Hopkins Hospital
    • Baltimore Maryland 21287 United States
    • University of Michigan
    • Ann Arbor Michigan 48109 United States
    • Icahn School of Medicine at Mount Sinai
    • New York New York 10019 United States
    • The University of Texas Medical Branch
    • Galveston Texas 77555 United States
    • University of Texas Medical School at Houston
    • Houston Texas 77030 United States

    View trial on ClinicalTrials.gov


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    Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease


    Condition: Cancer

    Intervention:

    • Drug: FACBC PET-CT Imaging

    Purpose: This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03081884

    Sponsor: Emory University

    Primary Outcome Measures:

    • Measure: Positivity rate of FACBC PET
    • Time Frame: Day 1
    • Safety Issue:
    • Measure: Correlation between FACBC PET findings and results of other tests
    • Time Frame: Day 1, Day of surgery
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Correlation between FACBC uptake in the prostate with presence of FACBC-detected metastasis
    • Time Frame: Day 1
    • Safety Issue:

    Estimated Enrollment: 88

    Study Start Date: March 1, 2017

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • High-risk prostate cancer patients eligible for standard of care surgery
    • At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
    • Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

    Exclusion Criteria:

    • Definitive findings of systemic metastasis on conventional imaging.

    Contact:

    • Mehrdad Alemozaffar
    • 404-778-5864

    Location:

    • Emory University Hospital
    • Atlanta Georgia 30322 United States

    View trial on ClinicalTrials.gov


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    [18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study


    Condition: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer

    Intervention:

    • Procedure: Computed Tomography
    • Drug: Fluciclovine F18
    • Procedure: Positron Emission Tomography

    Purpose: This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03707184

    Sponsor: University of Utah

    Primary Outcome Measures:

    • Measure: Mean standardized uptake value (SUVmean)
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Maximum standardized uptake value (SUVmax)
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Lesion uptake of 18F fluciclovine
    • Time Frame: Up to 6 months
    • Safety Issue:
    • Measure: Time to biochemical failure
    • Time Frame: Up to 2 years
    • Safety Issue:

    Estimated Enrollment: 15

    Study Start Date: September 18, 2018

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
    • Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
    • All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

    Exclusion Criteria:

    • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
    • Patients who require monitored anesthesia for PET scanning.
    • Patients who are too claustrophobic to undergo PET scanning.

    Contact:

    • Paige Nielsen
    • 801-585-5942

    Location:

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

    View trial on ClinicalTrials.gov


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


    Condition: Prostate Adenocarcinoma

    Intervention:

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

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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03496844

    Sponsor: University of Arizona

    Primary Outcome Measures:

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

    Estimated Enrollment: 20

    Study Start Date: April 15, 2018

    Eligibility:

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

    Inclusion Criteria:

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

    Exclusion Criteria:

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

    Contact:

    • Carol Stuehm
    • 5206268318

    Location:

    • University of Arizona
    • Tucson Arizona 85724 United States

    View trial on ClinicalTrials.gov


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    PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)


    Condition: Prostate Cancer, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Cancer

    Intervention:

    • Radiation: whole pelvic radiotherapy
    • Radiation: metastasis-directed treatment
    • Procedure: salvage Lymph Node Dissection
    • Drug: androgen deprivation therapy

    Purpose: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03569241

    Sponsor: University Ghent

    Primary Outcome Measures:

    • Measure: Metastases-free survival
    • Time Frame: 2 year
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Clinical Progression free survival
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: Biochemical progression-free survival
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: Toxicity: acute toxicity
    • Time Frame: 3 months
    • Safety Issue:
    • Measure: Toxicity: late toxicity
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: quality of life
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: Prostate cancer-specific survival
    • Time Frame: 5 year
    • Safety Issue:
    • Measure: Overall survival
    • Time Frame: 5 year
    • Safety Issue:
    • Measure: Time to start of hormonal treatment
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: Time to castration-resistant disease
    • Time Frame: 5 year
    • Safety Issue:
    • Measure: economical evaluation
    • Time Frame: 2 year
    • Safety Issue:
    • Measure: Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery
    • Time Frame: 3 months
    • Safety Issue:

    Estimated Enrollment: 178

    Study Start Date: April 27, 2018

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Histologically proven initial diagnosis of adenocarcinoma of the prostate
    • Biochemical relapse of prostate cancer following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2016.
    • Following radical prostatectomy, patients with a biochemical relapse are eligible in case a nodal relapse is detected in the pelvis even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage).
    • In case of a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence and patients with a confirmed local recurrence are eligible in case they also undergo a local salvage therapy. If imaging rules out local relapse, patients are eligible.
    • Nodal relapse in the pelvis on choline, PSMA or FACBC PET-CT with a maximum of 3 positive nodal lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
    • WHO performance state 0-1
    • Age >18 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
    • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

    Exclusion Criteria:

    • Bone or visceral metastases
    • Para-aortic lymph node metastases (above the aortic bifurcation)
    • Local relapse in the prostate gland or prostate bed not suitable for a curative treatment
    • Previous irradiation of the pelvic and or para-aortic nodes
    • Serum testosterone level <50ng/dl or 1.7 nmol/L at time of randomization
    • Symptomatic metastases
    • Lymph node metastases in previously irradiated areas resulting in dose constraint violation
    • Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
    • Contraindications to androgen deprivation therapy
    • PSA rise while on active treatment with (LHRH-agonist, LHRH-antagonist, anti-androgen, estrogen
    • Previous treatment with cytotoxic agent for PCa
    • Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
    • Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

    Contact:

    • Piet Ost, PhD
    • 003293323045

    Locations:

    • Epworth Healthcare
    • Melbourne Australia
    • GZA
    • Antwerp Belgium
    • AZ St-Lucas
    • Brugge Belgium
    • Institut Jules Bordet
    • Brussel Belgium
    • AZ Maria Middelares
    • Gent Belgium
    • University Hospital Ghent
    • Ghent 9000 Belgium
    • AZ Groeninge
    • Kortrijk Belgium
    • UZ Leuven
    • Leuven Belgium
    • CH Mouscron
    • Mouscron Belgium
    • University Hospital Schleswig-Holstein
    • Lübeck Germany
    • European Institute of Oncology
    • Milan Italy
    • Humanitas Research Hospital
    • Milan Italy
    • Ospedale Sacro Cuore-Don Calabria
    • Verona Italy
    • UMC Groningen
    • Groningen Netherlands
    • Oslo University Hospital
    • Oslo Norway
    • Cruces University Hospital
    • Barakaldo Spain
    • Universitario Quironsalud
    • Madrid Spain
    • Hospital Universitari i Politècnic la Fe
    • Valencia Spain
    • Universitätsspital Basel
    • Basel Switzerland
    • Universitätsklinik für Radio-Onkologie
    • Bern Switzerland
    • Hôpitaux Universitaires de Genève
    • Geneva Switzerland
    • Kantonsspital St. Gallen
    • Saint Gallen Switzerland
    • UniversitätsSpital Zürich
    • Zürich Switzerland

    View trial on ClinicalTrials.gov


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


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

    Intervention:

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

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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03827473

    Sponsor: University of Utah

    Primary Outcome Measures:

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

    Secondary Outcome Measures:

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

    Estimated Enrollment: 89

    Study Start Date: February 8, 2019

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Histologically diagnosed adenocarcinoma of the prostate.
    • Radiographically confirmed metastatic disease within 60 days of study enrollment.
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
    • Absolute neutrophil count (ANC) >= 1.5 k/uL.
    • Platelets >= 100 k/uL.
    • Hemoglobin >= 9 g/dL.
    • Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ? ULN.
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 ? ULN OR =< 4 ? ULN for subjects with liver metastases.
    • Creatinine < 1.5 ? ULN OR
    • Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 ? ULN.
    • Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 ? ULN
    • Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.
    • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

    Exclusion Criteria:

    • Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as defined by the treating physician.
    • No prior systemic therapy for metastatic prostate cancer except for ADT given concurrently with definitive radiation therapy.
    • Completed any hormone therapy for localized prostate cancer at least 9 months previously.
    • Patients must not have a histologic diagnosis of small cell prostate cancer or pure squamous cell prostate cancer.
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
    • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    • Cardiovascular disorders:
    • Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.
    • Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic event within 3 months before first dose.
    • Other clinically significant disorders that would preclude safe study participation. As defined by the treating physician.
    • Known history of testing positive for human immunodeficiency virus (HIV) and CD4 count is below 200 or known acquired immunodeficiency syndrome diagnosis.
    • Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive) and a detectable viral count at screening.
    • Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use while on trial for the duration of potential docetaxel treatment. Live vaccine use is acceptable after chemotherapy or for patients randomized to the abiraterone arm. There are no restrictions on inactive viruses.
    • Known prior severe hypersensitivity to investigational product or any component in its formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).

    Contact:

    • Grace Humiston
    • 801-587-4645

    Location:

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

    View trial on ClinicalTrials.gov


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    Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)


    Condition: Prostate Cancer

    Intervention:

    • Drug: Docetaxel 75 mg/m2
    • Drug: Docetaxel 60 mg/m2
    • Drug: Radium-223

    Purpose: The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03574571

    Sponsor: Memorial Sloan Kettering Cancer Center

    Primary Outcome Measures:

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

    Estimated Enrollment: 738

    Study Start Date: June 19, 2018

    Phase: Phase 3

    Eligibility:

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

    Inclusion Criteria:

    • Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
    • Males 18 years of age and above
    • Histological or cytological proof of prostate cancer
    • Documented progressive mCRPC based on at least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
    • Two or more bone lesions
    • ECOG 0- 1
    • Normal organ function with acceptable initial laboratory values within 14 days of randomization:
    • Albumin > 30 g/L
    • ANC ≥ 1.5 x 10^9/L
    • Hemoglobin ≥ 10 g/dL
    • Platelet count ≥ 100 x 10^9/L
    • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
    • Bilirubin ≤ ULN (unless documented Gilbert's disease)
    • SGOT (AST) ≤ 1.5 x ULN
    • SGPT (ALT) ≤ 1.5 x ULN
    • WBC count ≥ 3 x 10^9/L
    • Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
    • Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
    • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
    • Willing and able to comply with the protocol, including follow-up visits and examinations

    Exclusion Criteria:

    • Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
    • Received external beam radiotherapy within the 4 weeks prior to randomization.
    • Has an immediate need for external beam radiotherapy.
    • Has received any systemic bone-seeking radiopharmaceutical in the past.
    • Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
    • Has received four or more systemic anticancer regimens for mCRPC.
    • Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
    • A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
    • Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
    • Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
    • Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
    • Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
    • Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
    • Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
    • Has imminent or established cord compression based on clinical findings and/or MRI.
    • Known bone marrow dysplasia
    • Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
    • Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:
    • Uncontrolled infection
    • NYHA III or IV heart failure
    • Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
    • Known active infection with HIV, Hepatitis B or Hepatitis C

    Contact:

    • Michael Morris, MD
    • 646-422-4469

    Locations:

    • Yale University
    • New Haven Connecticut 06511 United States
    • Helen Graham Cancer Center (Christiana Care)
    • Newark Delaware 19713 United States
    • Rush University Medical Center
    • Chicago Illinois 606012 United States
    • Indiana University
    • Indianapolis Indiana 46202 United States
    • Ochsner Cancer Institute
    • New Orleans Louisiana 70121 United States
    • University of Maryland Medical Center
    • Baltimore Maryland 21201 United States
    • University of Massachusetts
    • Dorchester Massachusetts 01655 United States
    • University of Michigan Cancer Center
    • Ann Arbor Michigan 48109 United States
    • University of Michigan
    • Northville Michigan 48168 United States
    • GU Research Network / Urology Cancer Center
    • Omaha Nebraska 68130 United States
    • Urology Cancer Center and GU Research Network
    • Omaha Nebraska 68130 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89128 United States
    • Memoral Sloan Kettering Basking Ridge
    • Basking Ridge New Jersey 07920 United States
    • MD Anderson Cancer Center at Cooper
    • Camden New Jersey 08103 United States
    • Memoral Sloan Kettering Monmouth
    • Middletown New Jersey 07748 United States
    • Memorial Sloan Kettering Bergen
    • Montvale New Jersey 07645 United States
    • Roswell Park Cancer Institute
    • Buffalo New York 14263-0001 United States
    • Memorial Sloan Kettering Commack
    • Commack New York 11725 United States
    • Memorial Sloan Kettering Westchester
    • Harrison New York 10604 United States
    • Northwell Health
    • Manhasset New York 11030 United States
    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States
    • New York Presbyterian Hospital-Weill Medical College of Cornell University
    • New York New York 10065 United States
    • Bronx VA Hospital
    • New York New York 10468 United States
    • University of Rochester Medical Center
    • Rochester New York 14642 United States
    • Memorial Sloan Kettering Rockville Centre
    • Rockville Centre New York 11570 United States
    • Memorial Sloan Kettering Nassau
    • Uniondale New York 11553 United States
    • University of North Carolina
    • Chapel Hill North Carolina 27514 United States
    • University of Oklahoma
    • Oklahoma City Oklahoma 73104 United States
    • MidLantic Urology
    • Bala-Cynwyd Pennsylvania 19004 United States
    • MidLantic Urology
    • Bala-Cynwyd Pennsylvania 19004 United States
    • Medical University of South Carolina
    • Charleston South Carolina 29425 United States
    • Millennium Oncology
    • Houston Texas 77090 United States
    • Millennium Physicians
    • Houston Texas 77090 United States
    • University of Washington
    • Seattle Washington 98109 United States

    View trial on ClinicalTrials.gov


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    Phase III Randomized Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]


    Condition: Recurrent Prostate Carcinoma

    Intervention:

    • Drug: 68Ga-PSMA-11

    Purpose: To evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03582774

    Sponsor: Jonsson Comprehensive Cancer Center

    Primary Outcome Measures:

    • Measure: Rate of biochemical progression-free survival
    • Time Frame: Time Frame: From date of initiation of salvage radiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: 5-year progression-free survival rate
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Metastasis free-survival
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Rate of additional prostate cancer therapy initiation-free survival
    • Time Frame: assessed up to 5 years
    • Safety Issue:

    Estimated Enrollment: 193

    Study Start Date: July 12, 2018

    Phase: Phase 3

    Eligibility:

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

    Inclusion Criteria:

    • 1. Histopathology proven prostate cancer 2. Planned SRT for recurrence after primary prostatectomy 3. PSA ≥ 0.1ng/ml at time of enrollment 4. Willingness to undergo radiotherapy. 5. Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT

    Exclusion Criteria:

    1. Extra-pelvic metastasis on any imaging or biopsy
    2. Prior PSMA PET/CT
    3. Prior pelvic external beam radiation therapy (RT)
    4. Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT
    5. Contraindications to radiotherapy (including active inflammatory bowel disease)
    6. Concurrent systemic therapy for prostate cancer with investigational agents. -

    Contact:

    • Jeannine Gartmann
    • 310-206-0596

    Location:

    • UCLA
    • Los Angeles California 90095 United States

    View trial on ClinicalTrials.gov


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    A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies


    Condition: Prostate Cancer

    Intervention:

    • Drug: Testosterone cypionate
    • Drug: Testosterone Enanthate
    • Drug: Abiraterone acetate
    • Drug: Enzalutamide (Cohort A = CLOSED TO ACCRUAL)

    Purpose: Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll three cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B); and men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C).

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02090114

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Primary Outcome Measures:

    • Measure: Prostate Specific Antigen (PSA) response to Bipolar Androgen Therapy (BAT)
    • Time Frame: up to 18 months
    • Safety Issue:
    • Measure: PSA response to enzalutamide or abiraterone acetate post Bipolar Androgen Therapy
    • Time Frame: up to 24 months
    • Safety Issue:
    • Measure: PSA response to castrate levels of testosterone post Bipolar Androgen Therapy
    • Time Frame: up to 18 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: PSA progression on enzalutamide or abiraterone acetate or castrate levels post-BAT
    • Time Frame: up to 18 months
    • Safety Issue:
    • Measure: PSA progression on BAT (Bipolar Androgen Therapy )
    • Time Frame: up to 18 months
    • Safety Issue:
    • Measure: Disease response as defined by RECIST 1.1 (soft tissue lesions) and PCWG2 criteria (bone lesions)
    • Time Frame: up to 18 months
    • Safety Issue:
    • Measure: Initiation of docetaxel chemotherapy
    • Time Frame: up to 18 months
    • Safety Issue:
    • Measure: Quality of Life (QoL) as assessed by FACIT-F score
    • Time Frame: Change from baseline to 18 months
    • Safety Issue:
    • Measure: Safety and Tolerability as assessed by Number of Participants with Adverse Events
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Fasting glucose
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Hemoglobin A1c
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Fasting insulin
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Serum C-telopeptide
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Osteocalcin
    • Time Frame: On average at 18 months
    • Safety Issue:
    • Measure: Effect of treatment with testosterone and abiraterone acetate or enzalutamide on Bone Scan with SPECT CT
    • Time Frame: 18 months
    • Safety Issue:
    • Measure: Quality of Life (QoL) as assessed by RANDSF-36
    • Time Frame: Change from baseline to 18 months
    • Safety Issue:
    • Measure: Quality of Life (QoL) as assessed by BPI
    • Time Frame: Change from baseline to 18 months
    • Safety Issue:
    • Measure: Quality of Life (QoL) as assessed by IIEF
    • Time Frame: Change from baseline to 18 months
    • Safety Issue:
    • Measure: Quality of Life (QoL) as assessed by PANAS
    • Time Frame: Change from baseline to 18 months
    • Safety Issue:

    Estimated Enrollment: 90

    Study Start Date: June 2014

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    1. Performance status ≤2
    2. Age ≥18 years
    3. Histologically-confirmed adenocarcinoma of the prostate
    4. Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist).
    5. Documented castrate level of serum testosterone (<50 ng/dl).
    6. For Cohorts A and B, patients must have progressed on prior treatment with enzalutamide or abiraterone acetate + prednisone (by PSA criteria or radiographically).
    7. For castration-only Cohort C, patients must have developed castrate resistant prostate cancer after progressing on first line hormone therapy with either surgical castration or LHRH agonist or LHRH agonist plus an anti-androgen.
    8. Patients progressing on LHRH agonist plus an anti-androgen as first line therapy must be off anti-androgen for 4 weeks prior to first treatment with testosterone.
    9. Patients with rising PSA on two successive measurements at least two weeks apart.
    10. For Cohort A (enzalutamide) and Cohort B (abiraterone acetate):
    11. Prior treatment with up to 2 additional second line hormone therapies, including ketoconazole is allowed.
    12. Patients who have progressed on both enzalutamide and abiraterone acetate are eligible and post-BAT will be retreated with the last second line agent they had received (e.g. patient receiving abiraterone then enzalutamide would receive retreatment with enzalutamide post-BAT).
    13. Patients must be withdrawn from enzalutamide or abiraterone acetate for ≥ 4 weeks and have documented PSA increase after the withdrawal period.
    14. Patients receiving prednisone in conjunction with abiraterone acetate must be weaned off prednisone prior to starting BAT.
    15. For Cohort C (castration-only):
    16. Patients must continue on castrating therapy throughout BAT treatment.
    17. No prior second line hormone treatment with flutamide, bicalutamide, nilutamide, enzalutamide, abiraterone, ketoconazole, ARN-509 or other investigational androgen ablative therapies is permitted for Cohort C.
    18. Prior docetaxel for hormone-sensitive prostate cancer is permitted if ≤ 6 doses were given in conjunction with first-line androgen deprivation therapy and >12 months since last dose of docetaxel.
    19. Acceptable liver function:
    20. Bilirubin < 2.5 times institutional upper limit of normal (ULN)
    21. AST (SGOT) and ALT (SGPT) < 2.5 times ULN
    22. Acceptable renal function: a. Serum creatinine < 2.5 times ULN, OR
    23. Acceptable hematologic status:
    24. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
    25. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
    26. Hemoglobin ≥ 9 g/dL.
    27. At least 4 weeks since prior surgery with full recovery (no persistent toxicity ≥ Grade 1).
    28. Ability to understand and willingness to sign a written informed consent document.

    Exclusion Criteria:

    1. Pain due to metastatic prostate cancer requiring opioid analgesics.
    2. >5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤1 cm in diameter are permitted).
    3. Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited.
    4. Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement thought to be due to prostate cancer or benign prostatic hyperplasia.
    5. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction).
    6. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
    7. Active uncontrolled infection, including known history of AIDS or hepatitis B or C.
    8. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
    9. Prior history of a thromboembolic event within the last two years and not currently on systemic anticoagulation.
    10. Hematocrit >50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure [per Endocrine Society Clinical Practice Guidelines (67)].

    Contact:

    • Irina Rifkind, RN, MSN
    • 410-502-2043

    Location:

    • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore Maryland 21231 United States

    View trial on ClinicalTrials.gov


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    High Dose Testosterone in Men With Advanced Prostate Cancer and Homologous Recombination Deficiency


    Condition: Castration-resistant Prostate Cancer, Homologous Recombination Deficiency

    Intervention:

    • Drug: Testosterone Enanthate

    Purpose: The purpose of this study is to determine the efficacy of BAT in men with metastatic castrate-resistant prostate cancer (mCRPC) and homologous recombination deficiency (HRD). Bipolar androgen therapy will be administered to men confirmed to have HRD on tumour tissue and/or circulating tumour DNA analysis on pre-screening.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03522064

    Sponsor: St Vincent's Hospital, Sydney

    Primary Outcome Measures:

    • Measure: PSA Response Rate
    • Time Frame: 1 year
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Time to PSA progression
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Quality of Life
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Radiological Response Rate
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Safety and Tolerability (Frequency of adverse events as assessed by NCI CTCAE v4.0)
    • Time Frame: 1 year
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: July 30, 2018

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    1. Males with histologically confirmed adenocarcinoma of the prostate
    2. Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.
    3. Age ≥ 18 years
    4. ECOG performance status ≤ 1
    5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone
    6. Serum testosterone < 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year.
    7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)
    8. Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >100)
    9. Adequate liver function (ALT/AST < 1.5 x ULN, bilirubin < 2 x ULN)
    10. Adequate renal function (creatinine clearance > 50 ml/min)
    11. Adequate cardiac function and reserve after cardiology assessment
    12. Archived tissue sample available or willingness to undergo fresh biopsy
    13. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
    14. Signed, written informed consent

    Exclusion Criteria:

    1. Contraindications to investigational product
    2. Pain due to metastatic prostate cancer requiring opioid analgesics
    3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).
    4. Previous treatment with platinum chemotherapy and/or a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.
    5. Life expectancy of less than 3 months.
    6. Brain metastases or leptomeningeal disease
    7. History of thromboembolic event and not currently on anticoagulation
    8. Prior myocardial infarction or unstable angina within 2 years of study entry
    9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA >1)
    10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
    11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
    12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

    Contact:

    • Robert Kent
    • +61293555611

    Location:

    • Kinghorn Cancer Centre, St. Vincent's Hospital
    • Sydney New South Wales 2010 Australia

    View trial on ClinicalTrials.gov


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