Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (PREDICT)

June 1, 2026 updated by: Alliance for Clinical Trials in Oncology

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

I. Evaluate objective response rate in patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease, in each treatment arm.

SECONDARY OBJECITVES:

I. To determine safety and tolerability as determined by Common Terminology Criteria in Adverse Events (CTCAE) version 5.0 in each treatment arm.

II. To evaluate 9-month radiographic progression free survival in each arm as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG-3) for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

III. To evaluate radiographic progression free survival in each arm as defined by PCWG-3 for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

IV. To evaluate prostate-specific antigen (PSA) response defined as ≥ 50% decline in PSA from baseline using PCWG-3 criteria in patients in each treatment arm.

V. To evaluate time to PSA progression as defined by PCWG-3 criteria in patients in each treatment arm.

VI. To evaluate time to occurrence of first symptomatic skeletal event. VII. To evaluate time to first subsequent anti-cancer therapy (including androgen receptor signaling agents, cytotoxic chemotherapy, immunotherapy, or investigational agents) or death.

VIII. To evaluate overall survival, defined as time from registration to death due to any cause censored at the date of last follow-up, in each treatment arm.

IX. To evaluate patient-reported outcomes (PRO) via Patient-Reported Outcomes (PRO)-CTCAE in each treatment arm.

X. To evaluate duration of response as defined by RECIST version 1.1 for patients with measurable disease.

CORRELATIVE OBJECTIVES:

I. Correlate presence of molecular abnormalities with baseline clinical characteristics.

II. Evaluate co-occurring molecular alterations within each biomarker arm. III. Evaluate mechanisms of response and resistance using available tissue (archival or baseline) and circulating cell free tumor DNA (cfDNA) and circulating tumor cells (CTCs) at baseline, on treatment, and at progression.

IV. Evaluate efficacy parameters (objective response rate [ORR], PSA response, 9-month radiographic progression-free survival [rPFS], rPFS) based on arm allocation by:

IVa. DNA versus RNA qualifying molecular alterations; IVb. Blood versus tissue-based qualifying molecular alteration; IVc. Primary versus metastasis qualifying molecular alteration.

V. Evaluate efficacy parameters (ORR, PSA response, 9-month rPFS, rPFS) based on the following clinical parameters:

Va. Presence or absence of visceral metastases at baseline; Vb. Number of prior lines of therapy for metastatic castration resistant cancer (mCRPC) (one versus > 1); Vc. In patients having had prior exposure to taxane chemotherapy; Vd. Presence or absence of neuroendocrine differentiation at baseline. VI. Evaluate exceptional responders (defined as those with rPFS ≥ 18 months) and exceptional non-responders.

VII. To determine how circulating biomarker quantification correlates with clinical features and outcomes.

VIII. To determine the clinical impact of lineage plasticity alterations in predicting outcomes and response to therapy.

EXPLORATORY OBJECTIVE:

I. To compare patient-assessed adverse events via PRO-CTCAE™ with clinician-assessed adverse events in each treatment arm.

OUTLINE: Patients undergo genetic testing on previously-collected tissue samples. Patients are then assigned to 1 of 3 arms based on genetic testing results and Molecular Tumor Board (MTB) decision.

ARM A: Patients receive valemetostat tosylate orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carboplatin intravenously (IV) over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive one of the following treatment regimens per treating physician: 1) Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2) Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

All patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) and bone scan throughout the trial. Patients may also undergo optional fludeoxyglucose F-18 (FDG) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET), as well as optional blood collection throughout the trial.

After completion of study treatment, patients without disease progression are followed every 2 months for the first 6 months and then every 3 months after that for up to 5 years. Patients with disease progression are followed every 6 months for 5 years.

Study Type

Interventional

Enrollment (Estimated)

474

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Joelle Hamilton
        • Contact:
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Edward P. Gelmann
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Edward P. Gelmann
    • California
      • Chico, California, United States, 95926
        • Recruiting
        • Enloe Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-332-4700
        • Principal Investigator:
          • Nicholas Mitsiades
      • Encinitas, California, United States, 92024
        • Recruiting
        • UC San Diego Health System - Encinitas
        • Principal Investigator:
          • Rana R. McKay
        • Contact:
          • Site Public Contact
          • Phone Number: 760-536-7700
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Arash Rezazadeh Kalebasty
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Rana R. McKay
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Arash Rezazadeh Kalebasty
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Nicholas Mitsiades
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego Medical Center - Hillcrest
        • Principal Investigator:
          • Rana R. McKay
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Principal Investigator:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • Stamford Hospital/Bennett Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 203-323-8944
        • Principal Investigator:
          • Anthony P. Gulati
    • Delaware
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
    • Florida
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center
        • Principal Investigator:
          • Ryan H. Devine
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Recruiting
        • Tripler Army Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-433-6336
        • Principal Investigator:
          • Karen J. Shou
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Suspended
        • Kootenai Health - Coeur d'Alene
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Bettendorf, Iowa, United States, 52722
        • Recruiting
        • University of Iowa Healthcare Cancer Services Quad Cities
        • Principal Investigator:
          • Fernando Maciel Barbosa
        • Contact:
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Principal Investigator:
          • Fernando Maciel Barbosa
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • The University of Kansas Cancer Center - Olathe
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital-Indian Creek Campus
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 785-295-8000
        • Principal Investigator:
          • Elizabeth M. Wulff
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth M. Wulff
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Healthcare Edgewood
        • Principal Investigator:
          • Matthew Kurian
        • Contact:
      • Fort Thomas, Kentucky, United States, 41075
        • Suspended
        • Saint Elizabeth Healthcare Fort Thomas
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Suspended
        • Dana-Farber Cancer Institute
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Dana-Farber Cancer Institute at Foxborough
        • Principal Investigator:
          • Daniel Roberts
        • Contact:
          • Site Public Contact
          • Phone Number: 877-338-7425
      • Methuen, Massachusetts, United States, 01844
        • Recruiting
        • Dana Farber-Merrimack Valley
        • Contact:
          • Site Public Contact
          • Phone Number: 877-338-7425
        • Principal Investigator:
          • Pedro M. Sanz-Altamira
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
        • Contact:
          • Site Public Contact
          • Phone Number: 877-332-4294
        • Principal Investigator:
          • Daniel E. Fein
      • South Weymouth, Massachusetts, United States, 02190
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
        • Principal Investigator:
          • Thomas P. O'Connor
        • Contact:
          • Site Public Contact
          • Phone Number: 781-624-5000
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center
        • Contact:
        • Principal Investigator:
          • John C. McCann
    • Michigan
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Minnesota
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • Columbia, Missouri, United States, 65212
        • Active, not recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Eric M. Knoche
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Robert S. Alter
        • Contact:
          • Site Public Contact
          • Phone Number: 551-996-2897
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ellis G. Levine
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Eric J. Miller
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Catherine Fahey
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Attallah
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Gauntner
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Adanma Anji Ayanambakkam Attanathi
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Alexandra O. Sokolova
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Medical Group PC-Robert Packer Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-836-0388
        • Principal Investigator:
          • Joyson Poulose
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Union, South Carolina, United States, 29379
        • Recruiting
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Kerry R. Schaffer
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Joseph Vento
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Vento
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Contact:
        • Principal Investigator:
          • Joseph Vento
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Principal Investigator:
          • Joseph Vento
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Joseph Vento
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • John Melson
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23223
        • Recruiting
        • Bon Secours Richmond Community Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • John Melson
        • Contact:
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Active, not recruiting
        • West Virginia University Charleston Division
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Edwards Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Toni O. Pacioles
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Principal Investigator:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.
  • PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
  • PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
  • PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
  • PRE-REGISTRATION: Age ≥ 18 years.

  • REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND one or more of the following criteria (choose all the apply):

    • PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.
    • Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
    • Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  • REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
  • REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.

  • REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to > grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

    • Chemotherapy-induced neuropathy
    • Fatigue
    • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
  • REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
  • REGISTRATION: No major surgery within 4 weeks of registration.
  • REGISTRATION: No prior treatment with EZH inhibitors.
  • REGISTRATION: Prior treatment with cabazitaxel + carboplatin.

  • REGISTRATION: None of the following conditions:

    • Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
    • Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

    * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

    • Imminent or established spinal cord compression based on clinical and/or imaging findings.
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.
    • Significant cardiovascular defined as:
    • Myocardial infarction within 6 months prior to enrollment.
    • Uncontrolled angina pectoris within 6 months prior to enrollment.
    • New York Heart Association Class 3 or 4 congestive heart failure.
    • Corrected QT interval calculated by the Fridericia's formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.
    • Uncontrolled hypertension (resting systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg).
    • Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
    • Moderate to severe hepatic impairment (Child-Pugh Class C)
  • REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
  • REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
  • REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • REGISTRATION: No bleeding diathesis.
  • REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
  • REGISTRATION: Hemoglobin ≥ 9 g/dL.
  • REGISTRATION: Platelet count ≥ 100,000/mcL.
  • REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal [ULN] for subjects with documented Gilbert's disease).
  • REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
  • REGISTRATION: Albumin ≥ 2.8 g/dL.
  • REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.
  • RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).

  • RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to > grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

    • Chemotherapy-induced neuropathy
    • Fatigue
    • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).

  • RE-REGISTRATION: None of the following conditions:

    • Imminent or established spinal cord compression based on clinical and/or imaging findings.
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.
    • Corrected QT interval calculated by the Fridericia's formula (QTcF) < 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
    • Significant cardiovascular defined as:
    • Myocardial infarction within 6 months prior to enrollment.
    • Uncontrolled angina pectoris within 6 months prior to enrollment.
    • New York Heart Association Class 3 or 4 congestive heart failure.
    • Uncontrolled hypertension (resting systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
  • RE-REGISTRATION: ECOG Performance Status 0-2.
  • RE-REGISTRATION: No GCSF within 2 weeks of registration.
  • RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
  • RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • RE-REGISTRATION: WBC ≥ 2,500/mcL.
  • RE-REGISTRATION: ANC ≥ 1,500/mcL.
  • RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
  • RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
  • RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease).
  • RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
  • RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
  • RE-REGISTRATION: QT Interval (QTcF) < 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
  • RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (genetic testing, valemetostat tosylate)
Patients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Procedure: FDG-Positron Emission Tomography
Undergo FDG PET
Procedure: PSMA PET Scan
Undergo PSMA PET
Other Names:
  • Prostate-specific Membrane Antigen PET
Other: Genetic testing
undergo genetic testing
Drug: Valemetostat Tosylate
Given PO
Procedure: Magnetic Resonance Imaging
undergo Magnetic Resonance Imaging
Other Names:
  • MRI
Procedure: Computed Tomography
undergo Computed Tomography
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Bone scan
undergo Bone scan
Procedure: Biospecimen Collection
undergo blood collection
Experimental: Arm B (genetic testing, carboplatin, cabazitaxel)
Patients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Drug: Carboplatin
Given IV
Drug: Cabazitaxel
Given IV
Procedure: FDG-Positron Emission Tomography
Undergo FDG PET
Procedure: PSMA PET Scan
Undergo PSMA PET
Other Names:
  • Prostate-specific Membrane Antigen PET
Other: Genetic testing
undergo genetic testing
Procedure: Magnetic Resonance Imaging
undergo Magnetic Resonance Imaging
Other Names:
  • MRI
Procedure: Computed Tomography
undergo Computed Tomography
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Bone scan
undergo Bone scan
Procedure: Biospecimen Collection
undergo blood collection
Experimental: Arm C (genetic testing, physician choice treatment)
Patients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Drug: Enzalutamide
Given PO
Other Names:
  • Xtandi
Drug: Abiraterone Acetate
Given PO
Drug: Cabazitaxel
Given IV
Procedure: FDG-Positron Emission Tomography
Undergo FDG PET
Procedure: PSMA PET Scan
Undergo PSMA PET
Other Names:
  • Prostate-specific Membrane Antigen PET
Drug: Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
Other Names:
  • Pluvicto
Other: Genetic testing
undergo genetic testing
Procedure: Magnetic Resonance Imaging
undergo Magnetic Resonance Imaging
Other Names:
  • MRI
Procedure: Computed Tomography
undergo Computed Tomography
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Bone scan
undergo Bone scan
Procedure: Biospecimen Collection
undergo blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response
Time Frame: Within 6 months from the start of treatment
Objective response is defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) for patients with measurable disease.
Within 6 months from the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression Free Survival (rPFS)
Time Frame: From initiation of treatment up to 9 months
Radiographic progression is defined by PCWG-3 for patients with bone metastases and modified RECIST 1.1 criteria for patients with soft tissue metastases. The 9-month radiographic progression-free proportion will be estimated by treatment arm, where patients who withdraw from study after the start of treatment but prior to nine months of follow-up will be counted as failures. rPFS will be calculated from registration date under progression or death by any cause, censoring event-free patients at the date of last disease evaluation. Will be estimated in each treatment arm using the Kaplan-Meier method.
From initiation of treatment up to 9 months
Overall Survival
Time Frame: Up to 5 years after study registration
Will be calculated from registration date until death due to any cause, censoring event-free patients at the date of last contact. Will be estimated in each treatment arm using the Kaplan-Meier method.
Up to 5 years after study registration
Duration of Response
Time Frame: Up to 5 years after study registration
Will be estimated according to RECIST v1.1 for patients with measurable disease in each treatment arm using the cumulative incidence function.
Up to 5 years after study registration
Prostate-specific antigen response
Time Frame: Through treatment completion, an average of one year
Defined as greater than or equal to 50% decline in PSA from baseline using PCWG-3 criteria. Will be estimated as a proportion in each treatment arm.
Through treatment completion, an average of one year
Time to systematic skeletal events
Time Frame: Up to 5 years after registration
A skeletal related event is defined as the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention. Will be estimated in each treatment arm using the cumulative incidence function.
Up to 5 years after registration
Time to subsequent anti-cancer therapy
Time Frame: Up to 5 years after registration
Defined as time from registration to first subsequent anti-cancer therapy or death, censoring event-free patients at date of last follow-up. Will be estimated in each treatment arm using the cumulative incidence function.
Up to 5 years after registration
Rate of Grade 3+ AEs
Time Frame: Up to 6 months after completion of study treatment
Will be collected and graded according ot the NCI CTCAE v5.0 criteria and per PRO-CTCAE.
Up to 6 months after completion of study treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Cancer Institute PRO-CTCAE™ data
Time Frame: Up to 5 years after completion of study treatment
Will evaluate patient scores relative to clinician graded AEs.
Up to 5 years after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Rana McKay, MD, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

April 11, 2030

Study Completion (Estimated)

October 11, 2034

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A032102
  • NCI-2024-04960 (Other Identifier: NCI Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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