Actively Recruiting
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-05-08
474
Participants Needed
105
Research Sites
504 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological evidence of prostate cancer, including variant histologies such as neuroendocrine, small cell, and sarcomatoid prostate cancer.
- Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
- Available tissue procured within 12 months of pre-registration for submission.
- Molecular report from CLIA-certified next generation sequencing assay available.
- Age 18 years or older.
- Progressive metastatic castration-resistant prostate cancer defined by castrate serum testosterone < 50 ng/dL and one or more of: PSA progression, radiographic progression, or bone metastasis progression.
- Patients assigned to lutetium Lu 177 vipivotide tetraxetan must have PSMA positive mCRPC.
- Prior treatment with androgen receptor signaling inhibitor in metastatic hormone sensitive or mCRPC setting.
- Prior taxane therapy unless ineligible or refusal.
- Resolved toxicities from prior anticancer therapy with specific criteria for chronic stable grade 2 toxicities.
- No investigational agents or certain treatments within specified timeframes before registration.
- No major surgery within 4 weeks before registration.
- No prior treatment with EZH inhibitors.
- Prior treatment with cabazitaxel and carboplatin.
- No current use of moderate or strong CYP3A inducers.
- No known or suspected hypersensitivity to valemetostat tosylate or excipients.
- For chronic HBV infection, viral load must be undetectable; for HCV infection, treated and cured or undetectable viral load if on treatment.
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible.
- No imminent or established spinal cord compression.
- No known brain metastases unless treated and stable for at least 4 weeks.
- No significant cardiovascular conditions including recent myocardial infarction, uncontrolled angina, NYHA class 3 or 4 heart failure, QTcF ≥ 470 ms with cardiac history, uncontrolled hypertension.
- No clinically significant acute infections requiring systemic therapy.
- No moderate to severe hepatic impairment (Child-Pugh Class C).
- No sperm freezing or donation within 14 days prior to registration.
- ECOG performance status 0-2.
- Adequate blood counts and organ function based on specified lab values.
- Molecular tumor board review and assignment before registration.
- For re-registration, similar criteria apply with confirmation of progressive mCRPC and resolved toxicities.
You will not qualify if you...
- None specified beyond inclusion criteria; no additional exclusion criteria provided.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 105 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
3
UC San Diego Health System - Encinitas
Encinitas, California, United States, 92024
Actively Recruiting
4
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
5
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
6
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
8
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
9
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
10
Memorial Hospital North
Colorado Springs, Colorado, United States, 80920
Actively Recruiting
11
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Actively Recruiting
12
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States, 80528
Actively Recruiting
13
UCHealth Greeley Hospital
Greeley, Colorado, United States, 80631
Actively Recruiting
14
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
15
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States, 06904
Actively Recruiting
16
Beebe South Coastal Health Campus
Millville, Delaware, United States, 19967
Actively Recruiting
17
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
18
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
19
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Actively Recruiting
20
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Actively Recruiting
21
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
Actively Recruiting
22
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Suspended
23
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
24
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
25
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
26
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
27
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
28
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
29
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
30
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
31
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
32
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
33
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
34
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
35
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
36
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
37
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
38
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States, 52722
Actively Recruiting
39
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
40
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
41
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
42
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
43
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
44
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
45
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States, 41017
Actively Recruiting
46
Saint Elizabeth Healthcare Fort Thomas
Fort Thomas, Kentucky, United States, 41075
Suspended
47
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
48
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
49
Dana Farber-Merrimack Valley
Methuen, Massachusetts, United States, 01844
Actively Recruiting
50
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States, 01757
Actively Recruiting
51
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States, 02190
Actively Recruiting
52
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
53
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
54
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
55
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
56
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
57
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
58
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
59
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
60
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
61
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
62
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
63
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65212
Active, Not Recruiting
64
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
65
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
66
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
67
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
68
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
69
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
70
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
71
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
72
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
73
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
74
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
75
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
76
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
77
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
78
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
79
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
80
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
81
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Actively Recruiting
82
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Actively Recruiting
83
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
84
SMC Center for Hematology Oncology Union
Union, South Carolina, United States, 29379
Actively Recruiting
85
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
86
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
87
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, United States, 75237
Actively Recruiting
88
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Suspended
89
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
90
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States, 75080
Actively Recruiting
91
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States, 23116
Actively Recruiting
92
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States, 23114
Actively Recruiting
93
Bon Secours Richmond Community Hospital
Richmond, Virginia, United States, 23223
Actively Recruiting
94
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States, 23226
Actively Recruiting
95
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States, 23230
Actively Recruiting
96
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
97
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
98
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States, 98026
Actively Recruiting
99
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
Active, Not Recruiting
100
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Actively Recruiting
101
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
102
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
103
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
104
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
105
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
Research Team
R
Rana McKay, MD
CONTACT
S
Shiva Baghaie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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