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전이성 전립선암의 표적치료제, PREDICT 임상시험 (PREDICT)

2026년 11월 2일 업데이트: Alliance for Clinical Trials in Oncology

전립선암 치료의 정밀 진단(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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

474

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • 모병
        • University of Alabama at Birmingham Cancer Center
        • 수석 연구원:
          • Joelle Hamilton
        • 연락하다:
    • Arizona
      • Tucson, Arizona, 미국, 85719
        • 모병
        • Banner University Medical Center - Tucson
        • 연락하다:
        • 수석 연구원:
          • Edward P. Gelmann
      • Tucson, Arizona, 미국, 85719
        • 모병
        • University of Arizona Cancer Center-North Campus
        • 연락하다:
        • 수석 연구원:
          • Edward P. Gelmann
    • California
      • Chico, California, 미국, 95926
        • 모병
        • Enloe Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 530-332-4700
        • 수석 연구원:
          • Nicholas Mitsiades
      • Encinitas, California, 미국, 92024
        • 모병
        • UC San Diego Health System - Encinitas
        • 수석 연구원:
          • Rana R. McKay
        • 연락하다:
          • Site Public Contact
          • 전화번호: 760-536-7700
      • Irvine, California, 미국, 92612
        • 모집하지 않고 적극적으로
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, 미국, 92093
        • 모병
        • UC San Diego Moores Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Rana R. McKay
      • Orange, California, 미국, 92868
        • 모집하지 않고 적극적으로
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Sacramento, California, 미국, 95817
        • 모병
        • University of California Davis Comprehensive Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 916-734-3089
        • 수석 연구원:
          • Nicholas Mitsiades
      • San Diego, California, 미국, 92103
        • 모병
        • UC San Diego Medical Center - Hillcrest
        • 수석 연구원:
          • Rana R. McKay
        • 연락하다:
    • Colorado
      • Colorado Springs, Colorado, 미국, 80909
        • 모병
        • UCHealth Memorial Hospital Central
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
          • Site Public Contact
          • 전화번호: 719-365-2406
      • Colorado Springs, Colorado, 미국, 80920
        • 모병
        • Memorial Hospital North
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
          • Site Public Contact
          • 전화번호: 719-364-6700
      • Fort Collins, Colorado, 미국, 80524
        • 모병
        • Poudre Valley Hospital
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
          • Site Public Contact
          • 전화번호: 970-297-6150
      • Fort Collins, Colorado, 미국, 80528
        • 모병
        • Cancer Care and Hematology-Fort Collins
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
      • Greeley, Colorado, 미국, 80631
        • 모병
        • UCHealth Greeley Hospital
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
      • Loveland, Colorado, 미국, 80538
        • 모병
        • Medical Center of the Rockies
        • 수석 연구원:
          • Steven R. Schuster
        • 연락하다:
          • Site Public Contact
          • 전화번호: 970-203-7083
    • Connecticut
      • Stamford, Connecticut, 미국, 06904
        • 모병
        • Stamford Hospital/Bennett Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 203-323-8944
        • 수석 연구원:
          • Anthony P. Gulati
    • Delaware
      • Millville, Delaware, 미국, 19967
        • 모병
        • Beebe South Coastal Health Campus
        • 연락하다:
        • 수석 연구원:
          • Gregory A. Masters
      • Newark, Delaware, 미국, 19713
        • 모병
        • Helen F Graham Cancer Center
        • 수석 연구원:
          • Gregory A. Masters
        • 연락하다:
      • Newark, Delaware, 미국, 19713
        • 모병
        • Medical Oncology Hematology Consultants PA
        • 수석 연구원:
          • Gregory A. Masters
        • 연락하다:
      • Rehoboth Beach, Delaware, 미국, 19971
        • 모병
        • Beebe Health Campus
        • 연락하다:
        • 수석 연구원:
          • Gregory A. Masters
    • Florida
      • Jupiter, Florida, 미국, 33458
        • 모병
        • Jupiter Medical Center
        • 수석 연구원:
          • Ryan H. Devine
        • 연락하다:
    • Hawaii
      • Honolulu, Hawaii, 미국, 96859
        • 모병
        • Tripler Army Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 808-433-6336
        • 수석 연구원:
          • Karen J. Shou
    • Idaho
      • Coeur d'Alene, Idaho, 미국, 83814
        • 정지된
        • Kootenai Health - Coeur d'Alene
    • Illinois
      • Bloomington, Illinois, 미국, 61704
        • 모병
        • Illinois CancerCare-Bloomington
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Canton, Illinois, 미국, 61520
        • 모병
        • Illinois CancerCare-Canton
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Danville, Illinois, 미국, 61832
        • 모병
        • Carle at The Riverfront
        • 수석 연구원:
          • Priyank P. Patel
        • 연락하다:
      • Effingham, Illinois, 미국, 62401
        • 모병
        • Carle Physician Group-Effingham
        • 연락하다:
        • 수석 연구원:
          • Priyank P. Patel
      • Eureka, Illinois, 미국, 61530
        • 모병
        • Illinois CancerCare-Eureka
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Mattoon, Illinois, 미국, 61938
        • 모병
        • Carle Physician Group-Mattoon/Charleston
        • 연락하다:
        • 수석 연구원:
          • Priyank P. Patel
      • O'Fallon, Illinois, 미국, 62269
        • 모병
        • Cancer Care Center of O'Fallon
        • 수석 연구원:
          • Bryan A. Faller
        • 연락하다:
      • Ottawa, Illinois, 미국, 61350
        • 모병
        • Illinois CancerCare-Ottawa Clinic
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Pekin, Illinois, 미국, 61554
        • 모병
        • Illinois CancerCare-Pekin
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Peoria, Illinois, 미국, 61615
        • 모병
        • Illinois CancerCare-Peoria
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Peru, Illinois, 미국, 61354
        • 모병
        • Illinois CancerCare-Peru
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
      • Shiloh, Illinois, 미국, 62269
        • 모병
        • Memorial Hospital East
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
      • Urbana, Illinois, 미국, 61801
        • 모병
        • Carle Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Priyank P. Patel
      • Washington, Illinois, 미국, 61571
        • 모병
        • Illinois CancerCare - Washington
        • 연락하다:
        • 수석 연구원:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, 미국, 50010
        • 모병
        • McFarland Clinic - Ames
        • 수석 연구원:
          • Joseph J. Merchant
        • 연락하다:
      • Bettendorf, Iowa, 미국, 52722
        • 모병
        • University of Iowa Healthcare Cancer Services Quad Cities
        • 수석 연구원:
          • Fernando Maciel Barbosa
        • 연락하다:
      • Iowa City, Iowa, 미국, 52242
        • 모병
        • University of Iowa/Holden Comprehensive Cancer Center
        • 수석 연구원:
          • Fernando Maciel Barbosa
        • 연락하다:
          • Site Public Contact
          • 전화번호: 800-237-1225
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • 모병
        • University of Kansas Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Elizabeth M. Wulff
      • Olathe, Kansas, 미국, 66061
        • 모병
        • The University of Kansas Cancer Center - Olathe
        • 연락하다:
        • 수석 연구원:
          • Elizabeth M. Wulff
      • Overland Park, Kansas, 미국, 66211
        • 모병
        • University of Kansas Hospital-Indian Creek Campus
        • 연락하다:
        • 수석 연구원:
          • Elizabeth M. Wulff
      • Topeka, Kansas, 미국, 66606
        • 모병
        • University of Kansas Health System Saint Francis Campus
        • 연락하다:
          • Site Public Contact
          • 전화번호: 785-295-8000
        • 수석 연구원:
          • Elizabeth M. Wulff
      • Westwood, Kansas, 미국, 66205
        • 모병
        • University of Kansas Hospital-Westwood Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Elizabeth M. Wulff
    • Kentucky
      • Edgewood, Kentucky, 미국, 41017
        • 모병
        • Saint Elizabeth Healthcare Edgewood
        • 수석 연구원:
          • Matthew Kurian
        • 연락하다:
      • Fort Thomas, Kentucky, 미국, 41075
        • 정지된
        • Saint Elizabeth Healthcare Fort Thomas
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • 정지된
        • Dana-Farber Cancer Institute
      • Foxborough, Massachusetts, 미국, 02035
        • 모병
        • Dana-Farber Cancer Institute at Foxborough
        • 수석 연구원:
          • Daniel Roberts
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-338-7425
      • Methuen, Massachusetts, 미국, 01844
        • 모병
        • Dana Farber-Merrimack Valley
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-338-7425
        • 수석 연구원:
          • Pedro M. Sanz-Altamira
      • Milford, Massachusetts, 미국, 01757
        • 모병
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-332-4294
        • 수석 연구원:
          • Daniel E. Fein
      • South Weymouth, Massachusetts, 미국, 02190
        • 모병
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
        • 수석 연구원:
          • Thomas P. O'Connor
        • 연락하다:
          • Site Public Contact
          • 전화번호: 781-624-5000
      • Springfield, Massachusetts, 미국, 01199
        • 모병
        • Baystate Medical Center
        • 연락하다:
        • 수석 연구원:
          • John C. McCann
    • Michigan
      • Brighton, Michigan, 미국, 48114
        • 모병
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • 연락하다:
        • 수석 연구원:
          • Elie G. Dib
      • Canton, Michigan, 미국, 48188
        • 모병
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • 연락하다:
        • 수석 연구원:
          • Elie G. Dib
      • Chelsea, Michigan, 미국, 48118
        • 모병
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • 연락하다:
        • 수석 연구원:
          • Elie G. Dib
      • Lansing, Michigan, 미국, 48912
        • 모병
        • University of Michigan Health - Sparrow Lansing
        • 수석 연구원:
          • Elie G. Dib
        • 연락하다:
      • Livonia, Michigan, 미국, 48154
        • 모병
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • 연락하다:
        • 수석 연구원:
          • Elie G. Dib
      • Ypsilanti, Michigan, 미국, 48197
        • 모병
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • 연락하다:
        • 수석 연구원:
          • Elie G. Dib
    • Minnesota
      • Brainerd, Minnesota, 미국, 56401
        • 모병
        • Essentia Health Saint Joseph's Medical Center
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Duluth, Minnesota, 미국, 55805
        • 모병
        • Essentia Health Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
      • Saint Cloud, Minnesota, 미국, 56303
        • 모병
        • Coborn Cancer Center at Saint Cloud Hospital
        • 연락하다:
        • 수석 연구원:
          • Donald J. Jurgens
    • Missouri
      • City of Saint Peters, Missouri, 미국, 63376
        • 모병
        • Siteman Cancer Center at Saint Peters Hospital
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
      • Columbia, Missouri, 미국, 65212
        • 모집하지 않고 적극적으로
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, 미국, 63141
        • 모병
        • Siteman Cancer Center at West County Hospital
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University School of Medicine
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
      • St Louis, Missouri, 미국, 63129
        • 모병
        • Siteman Cancer Center-South County
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
      • St Louis, Missouri, 미국, 63136
        • 모병
        • Siteman Cancer Center at Christian Hospital
        • 연락하다:
        • 수석 연구원:
          • Eric M. Knoche
    • Montana
      • Billings, Montana, 미국, 59101
        • 모병
        • Billings Clinic Cancer Center
        • 수석 연구원:
          • John M. Schallenkamp
        • 연락하다:
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • Hackensack University Medical Center
        • 수석 연구원:
          • Robert S. Alter
        • 연락하다:
          • Site Public Contact
          • 전화번호: 551-996-2897
    • New York
      • Buffalo, New York, 미국, 14263
        • 모병
        • Roswell Park Cancer Institute
        • 연락하다:
        • 수석 연구원:
          • Ellis G. Levine
      • New York, New York, 미국, 10029
        • 모병
        • Mount Sinai Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 212-824-7309
          • 이메일: CCTO@mssm.edu
        • 수석 연구원:
          • Eric J. Miller
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • 모병
        • UNC Lineberger Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Catherine Fahey
    • North Dakota
      • Fargo, North Dakota, 미국, 58103
        • 모병
        • Essentia Health Cancer Center-South University Clinic
        • 연락하다:
        • 수석 연구원:
          • Bret E. Friday
    • Ohio
      • Cleveland, Ohio, 미국, 44109
        • 모병
        • MetroHealth Medical Center
        • 연락하다:
        • 수석 연구원:
          • Joseph Attallah
      • Columbus, Ohio, 미국, 43210
        • 모병
        • Ohio State University Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Timothy D. Gauntner
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • 모병
        • University of Oklahoma Health Sciences Center
        • 연락하다:
        • 수석 연구원:
          • Adanma Anji Ayanambakkam Attanathi
    • Oregon
      • Portland, Oregon, 미국, 97239
        • 모병
        • Oregon Health and Science University
        • 연락하다:
          • Site Public Contact
          • 전화번호: 503-494-1080
          • 이메일: trials@ohsu.edu
        • 수석 연구원:
          • Alexandra O. Sokolova
      • Portland, Oregon, 미국, 97213
        • 모병
        • Providence Portland Medical Center
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Portland, Oregon, 미국, 97225
        • 모병
        • Providence Saint Vincent Medical Center
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
    • Pennsylvania
      • Sayre, Pennsylvania, 미국, 18840
        • 모집하지 않고 적극적으로
        • Guthrie Medical Group PC-Robert Packer Hospital
    • South Carolina
      • Gaffney, South Carolina, 미국, 29341
        • 모병
        • Gibbs Cancer Center-Gaffney
        • 연락하다:
        • 수석 연구원:
          • Michael Humeniuk
      • Greer, South Carolina, 미국, 29651
        • 모병
        • Gibbs Cancer Center-Pelham
        • 연락하다:
        • 수석 연구원:
          • Michael Humeniuk
      • Spartanburg, South Carolina, 미국, 29303
        • 모병
        • Spartanburg Medical Center
        • 연락하다:
        • 수석 연구원:
          • Michael Humeniuk
      • Union, South Carolina, 미국, 29379
        • 모병
        • SMC Center for Hematology Oncology Union
        • 연락하다:
        • 수석 연구원:
          • Michael Humeniuk
    • Tennessee
      • Nashville, Tennessee, 미국, 37232
        • 정지된
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, 미국, 75390
        • 모병
        • UT Southwestern/Simmons Cancer Center-Dallas
        • 연락하다:
        • 수석 연구원:
          • Joseph Vento
      • Dallas, Texas, 미국, 75235
        • 정지된
        • Parkland Memorial Hospital
      • Dallas, Texas, 미국, 75237
        • 모병
        • UT Southwestern Simmons Cancer Center - RedBird
        • 수석 연구원:
          • Joseph Vento
        • 연락하다:
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • 연락하다:
        • 수석 연구원:
          • Joseph Vento
      • Richardson, Texas, 미국, 75080
        • 모병
        • UT Southwestern Clinical Center at Richardson/Plano
        • 연락하다:
        • 수석 연구원:
          • Joseph Vento
    • Virginia
      • Mechanicsville, Virginia, 미국, 23116
        • 모병
        • Bon Secours Memorial Regional Medical Center
        • 연락하다:
        • 수석 연구원:
          • Joseph D. Pennington
      • Midlothian, Virginia, 미국, 23114
        • 모병
        • Bon Secours Saint Francis Medical Center
        • 연락하다:
        • 수석 연구원:
          • Joseph D. Pennington
      • Richmond, Virginia, 미국, 23235
        • 모병
        • VCU Massey Cancer Center at Stony Point
        • 연락하다:
        • 수석 연구원:
          • John Melson
      • Richmond, Virginia, 미국, 23226
        • 모병
        • Bon Secours Saint Mary's Hospital
        • 연락하다:
        • 수석 연구원:
          • Joseph D. Pennington
      • Richmond, Virginia, 미국, 23230
        • 모병
        • Bon Secours Cancer Institute at Reynolds Crossing
        • 연락하다:
        • 수석 연구원:
          • Joseph D. Pennington
      • Richmond, Virginia, 미국, 23223
        • 모병
        • Bon Secours Richmond Community Hospital
        • 연락하다:
        • 수석 연구원:
          • Joseph D. Pennington
      • Richmond, Virginia, 미국, 23298
        • 모병
        • VCU Massey Comprehensive Cancer Center
        • 수석 연구원:
          • John Melson
        • 연락하다:
    • Washington
      • Edmonds, Washington, 미국, 98026
        • 모병
        • Swedish Cancer Institute-Edmonds
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
      • Seattle, Washington, 미국, 98122
        • 모병
        • Swedish Medical Center-First Hill
        • 수석 연구원:
          • Alison K. Conlin
        • 연락하다:
    • West Virginia
      • Charleston, West Virginia, 미국, 25304
        • 모집하지 않고 적극적으로
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Huntington, West Virginia, 미국, 25701
        • 모병
        • Edwards Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Toni O. Pacioles
    • Wisconsin
      • Marshfield, Wisconsin, 미국, 54449
      • Menomonee Falls, Wisconsin, 미국, 53051
        • 모병
        • Froedtert Menomonee Falls Hospital
        • 수석 연구원:
          • Kathryn A. Bylow
        • 연락하다:
          • Site Public Contact
          • 전화번호: 262-257-5100
      • Milwaukee, Wisconsin, 미국, 53226
        • 모병
        • Medical College of Wisconsin
        • 수석 연구원:
          • Kathryn A. Bylow
        • 연락하다:
          • Site Public Contact
          • 전화번호: 414-805-3666
      • Oak Creek, Wisconsin, 미국, 53154
        • 모병
        • Drexel Town Square Health Center
        • 수석 연구원:
          • Kathryn A. Bylow
        • 연락하다:
          • Site Public Contact
          • 전화번호: 414-805-0505
      • West Bend, Wisconsin, 미국, 53095
        • 모병
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • 수석 연구원:
          • Kathryn A. Bylow
        • 연락하다:
          • Site Public Contact
          • 전화번호: 414-805-0505

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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:

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Genetic testing

undergo genetic testing

의약품: Valemetostat Tosylate

Given PO

절차: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

다른 이름들:
  • MRI
절차: Computed Tomography

undergo Computed Tomography

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Bone scan

undergo Bone scan

절차: FDG-Positron Emission Tomography

Undergo FDG PET

절차: PSMA PET Scan

Undergo PSMA PET

다른 이름들:
  • 전립선 특이 막 항원 PET
절차: Biospecimen Collection

undergo blood collection
실험적: 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.
의약품: Carboplatin

Given IV

의약품: Cabazitaxel

Given IV

다른: Genetic testing

undergo genetic testing

절차: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

다른 이름들:
  • MRI
절차: Computed Tomography

undergo Computed Tomography

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Bone scan

undergo Bone scan

절차: FDG-Positron Emission Tomography

Undergo FDG PET

절차: PSMA PET Scan

Undergo PSMA PET

다른 이름들:
  • 전립선 특이 막 항원 PET
절차: Biospecimen Collection

undergo blood collection
실험적: 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.
의약품: Abiraterone Acetate

Given PO

의약품: Cabazitaxel

Given IV

다른: Genetic testing

undergo genetic testing

절차: Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

다른 이름들:
  • MRI
절차: Computed Tomography

undergo Computed Tomography

다른 이름들:
  • 고양이 스캔
  • CT 스캔
절차: Bone scan

undergo Bone scan

절차: FDG-Positron Emission Tomography

Undergo FDG PET

절차: PSMA PET Scan

Undergo PSMA PET

다른 이름들:
  • 전립선 특이 막 항원 PET
절차: Biospecimen Collection

undergo blood collection

의약품: Enzalutamide

Given PO

다른 이름들:
  • 엑스탄디
의약품: Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

다른 이름들:
  • 플루빅토

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Radiographic Progression Free Survival (rPFS)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
National Cancer Institute PRO-CTCAE™ data
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Rana McKay, MD, Alliance for Clinical Trials in Oncology

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 6일

기본 완료 (추정된)

2030년 4월 11일

연구 완료 (추정된)

2034년 10월 11일

연구 등록 날짜

최초 제출

2024년 10월 1일

QC 기준을 충족하는 최초 제출

2024년 10월 7일

처음 게시됨 (실제)

2024년 10월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A032102
  • NCI-2024-04960 (기타 식별자: NCI Clinical Trials Reporting Program)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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