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Gerichte behandeling voor gemetastaseerde prostaatkanker, de PREDICT-studie (PREDICT)

2 november 2026 bijgewerkt door: Alliance for Clinical Trials in Oncology

PREcisiediagnostiek bij de behandeling van prostaatkanker (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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

474

Fase

  • Fase 2

Contacten en locaties

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Studie Locaties

  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Werving
        • University of Alabama at Birmingham Cancer Center
        • Hoofdonderzoeker:
          • Joelle Hamilton
        • Contact:
    • Arizona
      • Tucson, Arizona, Verenigde Staten, 85719
        • Werving
        • Banner University Medical Center - Tucson
        • Contact:
        • Hoofdonderzoeker:
          • Edward P. Gelmann
      • Tucson, Arizona, Verenigde Staten, 85719
        • Werving
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Hoofdonderzoeker:
          • Edward P. Gelmann
    • California
      • Chico, California, Verenigde Staten, 95926
        • Werving
        • Enloe Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 530-332-4700
        • Hoofdonderzoeker:
          • Nicholas Mitsiades
      • Encinitas, California, Verenigde Staten, 92024
        • Werving
        • UC San Diego Health System - Encinitas
        • Hoofdonderzoeker:
          • Rana R. McKay
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 760-536-7700
      • Irvine, California, Verenigde Staten, 92612
        • Actief, niet wervend
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, Verenigde Staten, 92093
        • Werving
        • UC San Diego Moores Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Rana R. McKay
      • Orange, California, Verenigde Staten, 92868
        • Actief, niet wervend
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Sacramento, California, Verenigde Staten, 95817
        • Werving
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 916-734-3089
        • Hoofdonderzoeker:
          • Nicholas Mitsiades
      • San Diego, California, Verenigde Staten, 92103
        • Werving
        • UC San Diego Medical Center - Hillcrest
        • Hoofdonderzoeker:
          • Rana R. McKay
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, Verenigde Staten, 80909
        • Werving
        • UCHealth Memorial Hospital Central
        • Hoofdonderzoeker:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 719-365-2406
      • Colorado Springs, Colorado, Verenigde Staten, 80920
        • Werving
        • Memorial Hospital North
        • Hoofdonderzoeker:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 719-364-6700
      • Fort Collins, Colorado, Verenigde Staten, 80524
        • Werving
        • Poudre Valley Hospital
        • Hoofdonderzoeker:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 970-297-6150
      • Fort Collins, Colorado, Verenigde Staten, 80528
        • Werving
        • Cancer Care and Hematology-Fort Collins
        • Hoofdonderzoeker:
          • Steven R. Schuster
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      • Greeley, Colorado, Verenigde Staten, 80631
        • Werving
        • UCHealth Greeley Hospital
        • Hoofdonderzoeker:
          • Steven R. Schuster
        • Contact:
      • Loveland, Colorado, Verenigde Staten, 80538
        • Werving
        • Medical Center of the Rockies
        • Hoofdonderzoeker:
          • Steven R. Schuster
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 970-203-7083
    • Connecticut
      • Stamford, Connecticut, Verenigde Staten, 06904
        • Werving
        • Stamford Hospital/Bennett Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 203-323-8944
        • Hoofdonderzoeker:
          • Anthony P. Gulati
    • Delaware
      • Millville, Delaware, Verenigde Staten, 19967
        • Werving
        • Beebe South Coastal Health Campus
        • Contact:
        • Hoofdonderzoeker:
          • Gregory A. Masters
      • Newark, Delaware, Verenigde Staten, 19713
        • Werving
        • Helen F Graham Cancer Center
        • Hoofdonderzoeker:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, Verenigde Staten, 19713
        • Werving
        • Medical Oncology Hematology Consultants PA
        • Hoofdonderzoeker:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, Verenigde Staten, 19971
        • Werving
        • Beebe Health Campus
        • Contact:
        • Hoofdonderzoeker:
          • Gregory A. Masters
    • Florida
      • Jupiter, Florida, Verenigde Staten, 33458
        • Werving
        • Jupiter Medical Center
        • Hoofdonderzoeker:
          • Ryan H. Devine
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96859
        • Werving
        • Tripler Army Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 808-433-6336
        • Hoofdonderzoeker:
          • Karen J. Shou
    • Idaho
      • Coeur d'Alene, Idaho, Verenigde Staten, 83814
        • Geschorst
        • Kootenai Health - Coeur d'Alene
    • Illinois
      • Bloomington, Illinois, Verenigde Staten, 61704
        • Werving
        • Illinois CancerCare-Bloomington
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Canton, Illinois, Verenigde Staten, 61520
        • Werving
        • Illinois CancerCare-Canton
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Danville, Illinois, Verenigde Staten, 61832
        • Werving
        • Carle at The Riverfront
        • Hoofdonderzoeker:
          • Priyank P. Patel
        • Contact:
      • Effingham, Illinois, Verenigde Staten, 62401
        • Werving
        • Carle Physician Group-Effingham
        • Contact:
        • Hoofdonderzoeker:
          • Priyank P. Patel
      • Eureka, Illinois, Verenigde Staten, 61530
        • Werving
        • Illinois CancerCare-Eureka
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Mattoon, Illinois, Verenigde Staten, 61938
        • Werving
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Hoofdonderzoeker:
          • Priyank P. Patel
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • Werving
        • Cancer Care Center of O'Fallon
        • Hoofdonderzoeker:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Werving
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Pekin, Illinois, Verenigde Staten, 61554
        • Werving
        • Illinois CancerCare-Pekin
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Peoria, Illinois, Verenigde Staten, 61615
        • Werving
        • Illinois CancerCare-Peoria
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Peru, Illinois, Verenigde Staten, 61354
        • Werving
        • Illinois CancerCare-Peru
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
      • Shiloh, Illinois, Verenigde Staten, 62269
        • Werving
        • Memorial Hospital East
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
      • Urbana, Illinois, Verenigde Staten, 61801
        • Werving
        • Carle Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Priyank P. Patel
      • Washington, Illinois, Verenigde Staten, 61571
        • Werving
        • Illinois CancerCare - Washington
        • Contact:
        • Hoofdonderzoeker:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, Verenigde Staten, 50010
        • Werving
        • McFarland Clinic - Ames
        • Hoofdonderzoeker:
          • Joseph J. Merchant
        • Contact:
      • Bettendorf, Iowa, Verenigde Staten, 52722
        • Werving
        • University of Iowa Healthcare Cancer Services Quad Cities
        • Hoofdonderzoeker:
          • Fernando Maciel Barbosa
        • Contact:
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Werving
        • University of Iowa/Holden Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • Fernando Maciel Barbosa
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-237-1225
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • Werving
        • University of Kansas Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Elizabeth M. Wulff
      • Olathe, Kansas, Verenigde Staten, 66061
        • Werving
        • The University of Kansas Cancer Center - Olathe
        • Contact:
        • Hoofdonderzoeker:
          • Elizabeth M. Wulff
      • Overland Park, Kansas, Verenigde Staten, 66211
        • Werving
        • University of Kansas Hospital-Indian Creek Campus
        • Contact:
        • Hoofdonderzoeker:
          • Elizabeth M. Wulff
      • Topeka, Kansas, Verenigde Staten, 66606
        • Werving
        • University of Kansas Health System Saint Francis Campus
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 785-295-8000
        • Hoofdonderzoeker:
          • Elizabeth M. Wulff
      • Westwood, Kansas, Verenigde Staten, 66205
        • Werving
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Elizabeth M. Wulff
    • Kentucky
      • Edgewood, Kentucky, Verenigde Staten, 41017
        • Werving
        • Saint Elizabeth Healthcare Edgewood
        • Hoofdonderzoeker:
          • Matthew Kurian
        • Contact:
      • Fort Thomas, Kentucky, Verenigde Staten, 41075
        • Geschorst
        • Saint Elizabeth Healthcare Fort Thomas
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Geschorst
        • Dana-Farber Cancer Institute
      • Foxborough, Massachusetts, Verenigde Staten, 02035
        • Werving
        • Dana-Farber Cancer Institute at Foxborough
        • Hoofdonderzoeker:
          • Daniel Roberts
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 877-338-7425
      • Methuen, Massachusetts, Verenigde Staten, 01844
        • Werving
        • Dana Farber-Merrimack Valley
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 877-338-7425
        • Hoofdonderzoeker:
          • Pedro M. Sanz-Altamira
      • Milford, Massachusetts, Verenigde Staten, 01757
        • Werving
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 877-332-4294
        • Hoofdonderzoeker:
          • Daniel E. Fein
      • South Weymouth, Massachusetts, Verenigde Staten, 02190
        • Werving
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
        • Hoofdonderzoeker:
          • Thomas P. O'Connor
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 781-624-5000
      • Springfield, Massachusetts, Verenigde Staten, 01199
        • Werving
        • Baystate Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • John C. McCann
    • Michigan
      • Brighton, Michigan, Verenigde Staten, 48114
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Hoofdonderzoeker:
          • Elie G. Dib
      • Canton, Michigan, Verenigde Staten, 48188
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Hoofdonderzoeker:
          • Elie G. Dib
      • Chelsea, Michigan, Verenigde Staten, 48118
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Elie G. Dib
      • Lansing, Michigan, Verenigde Staten, 48912
        • Werving
        • University of Michigan Health - Sparrow Lansing
        • Hoofdonderzoeker:
          • Elie G. Dib
        • Contact:
      • Livonia, Michigan, Verenigde Staten, 48154
      • Ypsilanti, Michigan, Verenigde Staten, 48197
        • Werving
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Hoofdonderzoeker:
          • Elie G. Dib
    • Minnesota
      • Brainerd, Minnesota, Verenigde Staten, 56401
        • Werving
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Duluth, Minnesota, Verenigde Staten, 55805
        • Werving
        • Essentia Health Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
      • Saint Cloud, Minnesota, Verenigde Staten, 56303
        • Werving
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Donald J. Jurgens
    • Missouri
      • City of Saint Peters, Missouri, Verenigde Staten, 63376
        • Werving
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
      • Columbia, Missouri, Verenigde Staten, 65212
        • Actief, niet wervend
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, Verenigde Staten, 63141
        • Werving
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
      • St Louis, Missouri, Verenigde Staten, 63129
        • Werving
        • Siteman Cancer Center-South County
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
      • St Louis, Missouri, Verenigde Staten, 63136
        • Werving
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Eric M. Knoche
    • Montana
      • Billings, Montana, Verenigde Staten, 59101
        • Werving
        • Billings Clinic Cancer Center
        • Hoofdonderzoeker:
          • John M. Schallenkamp
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Werving
        • Hackensack University Medical Center
        • Hoofdonderzoeker:
          • Robert S. Alter
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 551-996-2897
    • New York
      • Buffalo, New York, Verenigde Staten, 14263
        • Werving
        • Roswell Park Cancer Institute
        • Contact:
        • Hoofdonderzoeker:
          • Ellis G. Levine
      • New York, New York, Verenigde Staten, 10029
        • Werving
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 212-824-7309
          • E-mail: CCTO@mssm.edu
        • Hoofdonderzoeker:
          • Eric J. Miller
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Werving
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Catherine Fahey
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58103
        • Werving
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Hoofdonderzoeker:
          • Bret E. Friday
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44109
        • Werving
        • MetroHealth Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Joseph Attallah
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Timothy D. Gauntner
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Werving
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Hoofdonderzoeker:
          • Adanma Anji Ayanambakkam Attanathi
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Werving
        • Oregon Health and Science University
        • Contact:
        • Hoofdonderzoeker:
          • Alexandra O. Sokolova
      • Portland, Oregon, Verenigde Staten, 97213
        • Werving
        • Providence Portland Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, Verenigde Staten, 97225
        • Werving
        • Providence Saint Vincent Medical Center
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
    • Pennsylvania
      • Sayre, Pennsylvania, Verenigde Staten, 18840
        • Actief, niet wervend
        • Guthrie Medical Group PC-Robert Packer Hospital
    • South Carolina
      • Gaffney, South Carolina, Verenigde Staten, 29341
        • Werving
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Hoofdonderzoeker:
          • Michael Humeniuk
      • Greer, South Carolina, Verenigde Staten, 29651
        • Werving
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Hoofdonderzoeker:
          • Michael Humeniuk
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Werving
        • Spartanburg Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Michael Humeniuk
      • Union, South Carolina, Verenigde Staten, 29379
        • Werving
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Hoofdonderzoeker:
          • Michael Humeniuk
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Geschorst
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, Verenigde Staten, 75390
        • Werving
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Hoofdonderzoeker:
          • Joseph Vento
      • Dallas, Texas, Verenigde Staten, 75235
        • Geschorst
        • Parkland Memorial Hospital
      • Dallas, Texas, Verenigde Staten, 75237
        • Werving
        • UT Southwestern Simmons Cancer Center - RedBird
        • Hoofdonderzoeker:
          • Joseph Vento
        • Contact:
      • Fort Worth, Texas, Verenigde Staten, 76104
        • Werving
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Hoofdonderzoeker:
          • Joseph Vento
      • Richardson, Texas, Verenigde Staten, 75080
        • Werving
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Hoofdonderzoeker:
          • Joseph Vento
    • Virginia
      • Mechanicsville, Virginia, Verenigde Staten, 23116
        • Werving
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Joseph D. Pennington
      • Midlothian, Virginia, Verenigde Staten, 23114
        • Werving
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Joseph D. Pennington
      • Richmond, Virginia, Verenigde Staten, 23235
        • Werving
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Hoofdonderzoeker:
          • John Melson
      • Richmond, Virginia, Verenigde Staten, 23226
        • Werving
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Joseph D. Pennington
      • Richmond, Virginia, Verenigde Staten, 23230
        • Werving
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Hoofdonderzoeker:
          • Joseph D. Pennington
      • Richmond, Virginia, Verenigde Staten, 23223
        • Werving
        • Bon Secours Richmond Community Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Joseph D. Pennington
      • Richmond, Virginia, Verenigde Staten, 23298
        • Werving
        • VCU Massey Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • John Melson
        • Contact:
    • Washington
      • Edmonds, Washington, Verenigde Staten, 98026
        • Werving
        • Swedish Cancer Institute-Edmonds
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, Verenigde Staten, 98122
        • Werving
        • Swedish Medical Center-First Hill
        • Hoofdonderzoeker:
          • Alison K. Conlin
        • Contact:
    • West Virginia
      • Charleston, West Virginia, Verenigde Staten, 25304
        • Actief, niet wervend
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Huntington, West Virginia, Verenigde Staten, 25701
        • Werving
        • Edwards Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Toni O. Pacioles
    • Wisconsin
      • Marshfield, Wisconsin, Verenigde Staten, 54449
      • Menomonee Falls, Wisconsin, Verenigde Staten, 53051
        • Werving
        • Froedtert Menomonee Falls Hospital
        • Hoofdonderzoeker:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 262-257-5100
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Medical College of Wisconsin
        • Hoofdonderzoeker:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 414-805-3666
      • Oak Creek, Wisconsin, Verenigde Staten, 53154
        • Werving
        • Drexel Town Square Health Center
        • Hoofdonderzoeker:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 414-805-0505
      • West Bend, Wisconsin, Verenigde Staten, 53095
        • Werving
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Hoofdonderzoeker:
          • Kathryn A. Bylow
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 414-805-0505

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Genetic testing

undergo genetic testing

Geneesmiddel: Valemetostat Tosylate

Given PO

Procedure: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

Andere namen:
  • MRI
Procedure: Computed Tomography

undergo Computed Tomography

Andere namen:
  • CT-scan
Procedure: Bone scan

undergo Bone scan

Procedure: FDG-Positron Emission Tomography

Undergo FDG PET

Procedure: PSMA PET Scan

Undergo PSMA PET

Andere namen:
  • Prostaatspecifiek membraanantigeen PET
Procedure: Biospecimen Collection

undergo blood collection
Experimenteel: 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.
Geneesmiddel: Carboplatin

Given IV

Geneesmiddel: Cabazitaxel

Given IV

Ander: Genetic testing

undergo genetic testing

Procedure: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

Andere namen:
  • MRI
Procedure: Computed Tomography

undergo Computed Tomography

Andere namen:
  • CT-scan
Procedure: Bone scan

undergo Bone scan

Procedure: FDG-Positron Emission Tomography

Undergo FDG PET

Procedure: PSMA PET Scan

Undergo PSMA PET

Andere namen:
  • Prostaatspecifiek membraanantigeen PET
Procedure: Biospecimen Collection

undergo blood collection
Experimenteel: 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.
Geneesmiddel: Abiraterone Acetate

Given PO

Geneesmiddel: Cabazitaxel

Given IV

Ander: Genetic testing

undergo genetic testing

Procedure: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

Andere namen:
  • MRI
Procedure: Computed Tomography

undergo Computed Tomography

Andere namen:
  • CT-scan
Procedure: Bone scan

undergo Bone scan

Procedure: FDG-Positron Emission Tomography

Undergo FDG PET

Procedure: PSMA PET Scan

Undergo PSMA PET

Andere namen:
  • Prostaatspecifiek membraanantigeen PET
Procedure: Biospecimen Collection

undergo blood collection

Geneesmiddel: Enzalutamide

Given PO

Andere namen:
  • Xtandi
Geneesmiddel: Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

Andere namen:
  • Pluvicto

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiographic Progression Free Survival (rPFS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
National Cancer Institute PRO-CTCAE™ data
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Rana McKay, MD, Alliance for Clinical Trials in Oncology

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 februari 2025

Primaire voltooiing (Geschat)

11 april 2030

Studie voltooiing (Geschat)

11 oktober 2034

Studieregistratiedata

Eerst ingediend

1 oktober 2024

Eerst ingediend dat voldeed aan de QC-criteria

7 oktober 2024

Eerst geplaatst (Werkelijk)

9 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A032102
  • NCI-2024-04960 (Andere identificatie: NCI Clinical Trials Reporting Program)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren