A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer
Summary
The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
Arms & interventions
- BiologicalPasritamig
Pasritamig will be administrated through IV infusion.
- OtherPlacebo
Placebo will be administrated through IV infusion.
- DrugBest Supportive Care (BSC)
BSC will be administered at the discretion of the treating physician.
Outcome measures
Primary
Overall Survival (OS)
OS is defined as the time from randomization to date of death due to any cause.
Time frame: Up to 2 years and 8 months
Secondary
Radiographic Progression-free Survival (rPFS)
Time frame: Up to 2 years and 8 months
Time to Symptomatic Progression
Time frame: Up to 2 years and 8 months
Time to Skeletal-Related Event
Time frame: Up to 2 years and 8 months
Progression-Free Survival (PFS)
Time frame: Up to 2 years and 8 months
Time to Prostate Specific Antigen (PSA) Progression
Time frame: Up to 2 years and 8 months
Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours
Time frame: Up to 2 years and 8 months
Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score
Time frame: Up to 2 years and 8 months
Number of Participants with Adverse Events (AEs)
Time frame: Up to 2 years and 8 months
Number of Participants with Abnormalities in Clinical Laboratory Assessments
Time frame: Up to 2 years and 8 months
Eligibility criteria
Study locations (50)
University of California at San Diego
La Jolla, California, 92093
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
University of Colorado Cancer Center
Aurora, Colorado, 80045
Colorado Clinical Research
Lakewood, Colorado, 80228
Hartford Hospital
Hartford, Connecticut, 06102
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901
Moffitt Cancer Center
Tampa, Florida, 33612
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Mission Cancer Blood
Waukee, Iowa, 50263
East Jefferson General Hospital
Metairie, Louisiana, 70006
Johns Hopkins University
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Michigan Health System
Ann Arbor, Michigan, 48109
Henry Ford Cancer Detroit
Detroit, Michigan, 48202
University Of Minnesota Medical Center
Minneapolis, Minnesota, 55455
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130
NYU Langone Hospitals
Brooklyn, New York, 11220
NYU Langone Hospital Long Island
Mineola, New York, 11501
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Cincinnati
Cincinnati, Ohio, 45219
University Hospital of Cleveland
Cleveland, Ohio, 44106
Compass Oncology
Portland, Oregon, 97227
VA Portland Health Care System
Portland, Oregon, 97239
Oregon Urology Institute
Springfield, Oregon, 97477
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Keystone Urology Specialists
Lancaster, Pennsylvania, 17601
Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Ralph H Johnson Veterans Hospital
Charleston, South Carolina, 29401
Gibbs Cancer Center and Research Institute Pelham
Greer, South Carolina, 29650
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404
Tennessee Oncology Nashville
Nashville, Tennessee, 37203
Urology Clinics of North Texas
Dallas, Texas, 75231
UT Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Texas Oncology West Texas
Wichita Falls, Texas, 76310
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Virginia Oncology Associates
Norfolk, Virginia, 23502
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
VA Puget Sound Healthcare System
Seattle, Washington, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
University of Washington
Seattle, Washington, 98195