A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07164443
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Castration-resistant Prostate Neoplasms

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pasritamig — BIOLOGICAL
    Pasritamig will be administrated through IV infusion.
  • Placebo — OTHER
    Placebo will be administrated through IV infusion.
  • Best Supportive Care (BSC) — DRUG
    BSC will be administered at the discretion of the treating physician.

Study Details

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).

Key Dates

Start date
Sep 2, 2025
Status verified
Jun 2026
Primary completion
Dec 29, 2027
Completion
Dec 29, 2027

Study Design

Enrollment
663 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pasritamig Plus Best Supportive Care (BSC)
    Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15. From C2D1 onwards participants will receive pasritamig target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
  • Placebo Comparator: Placebo Plus BSC
    Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 2 years and 8 months ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
University of California at San DiegoLa JollaCalifornia92093-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Rocky Mountain Cancer CentersAuroraColorado80012-
University of Colorado Cancer CenterAuroraColorado80045-
Colorado Clinical ResearchLakewoodColorado80228-
Hartford HospitalHartfordConnecticut06102-
Johns Hopkins Office of Capital Region Research - Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Bay Pines VA Healthcare SystemBay PinesFlorida33744-
Florida Cancer Specialists & Research InstituteFort MyersFlorida33901-
Moffitt Cancer CenterTampaFlorida33612-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Mission Cancer BloodWaukeeIowa50263-
East Jefferson General HospitalMetairieLouisiana70006-
Johns Hopkins UniversityBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Health SystemAnn ArborMichigan48109-
Henry Ford Cancer DetroitDetroitMichigan48202-
University Of Minnesota Medical CenterMinneapolisMinnesota55455-
XCancer Omaha / Urology Cancer CenterOmahaNebraska68130-
NYU Langone HospitalsBrooklynNew York11220-
NYU Langone Hospital Long IslandMineolaNew York11501-
Columbia University Medical CenterNew YorkNew York10032-
NYU Langone Health Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
University of CincinnatiCincinnatiOhio45219-
University Hospital of ClevelandClevelandOhio44106-
Compass OncologyPortlandOregon97227-
VA Portland Health Care SystemPortlandOregon97239-
Oregon Urology InstituteSpringfieldOregon97477-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17601-
Penn Medicine Abramson Cancer CenterPhiladelphiaPennsylvania19104-
UPMC Cancer CentersPittsburghPennsylvania15232-
Ralph H Johnson Veterans HospitalCharlestonSouth Carolina29401-
Gibbs Cancer Center and Research Institute PelhamGreerSouth Carolina29650-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Gibbs Cancer CenterSpartanburgSouth Carolina29303-
Tennessee Oncology - ChattanoogaChattanoogaTennessee37404-
Tennessee Oncology NashvilleNashvilleTennessee37203-
Urology Clinics of North TexasDallasTexas75231-
UT Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Michael E DeBakey VA Medical CenterHoustonTexas77030-
Texas Oncology West TexasWichita FallsTexas76310-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-
Blue Ridge Cancer CareRoanokeVirginia24014-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
University of WashingtonSeattleWashington98195-
VA Puget Sound Healthcare SystemSeattleWashington98108-

Find similar trials in La Jolla, CA

By research site
University of California at San Diego· La Jolla, CARonald Reagan UCLA Medical Center· Los Angeles, CARocky Mountain Cancer Centers· Aurora, COUniversity of Colorado Cancer Center· Aurora, COColorado Clinical Research· Lakewood, COHartford Hospital· Hartford, CT

Related Studies