A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pasritamig, Docetaxel, Prednisone/Prednisolone.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasms, Castration-Resistant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Brazil, Canada +12
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
Overview
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).
Interventions
- Drug Pasritamig
Pasritamig will be administered. - Drug Docetaxel
Docetaxel will be administered. - Drug Prednisone/Prednisolone
Prednisone/Prednisolone will be administered.
Primary outcome measures
- Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 1 years 10 months]
Secondary outcome measures (12)
- Overall Survival (OS) [Time frame: Up to approximately 4 years 5 months]
- Time to Symptomatic Progression (TSP) [Time frame: Up to approximately 4 years 5 months]
- Time to Subsequent Therapy (TST) [Time frame: Up to approximately 4 years 5 months]
- Time to Skeletal-Related Event (TSRE) [Time frame: Up to approximately 4 years 5 months]
- Objective Response Rate (ORR) [Time frame: Up to approximately 4 years 5 months]
- Duration of Response (DOR) [Time frame: Up to approximately 4 years 5 months]
- Time to Prostate-Specific Antigen (PSA) Progression [Time frame: Up to approximately 4 years 5 months]
- Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 50 Response [Time frame: Up to approximately 4 years 5 months]
- Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 90 Response [Time frame: Up to approximately 4 years 5 months]
- Duration of PSA Response [Time frame: Baseline and up to approximately 4 years 5 months]
- Progression Free Survival After Subsequent Therapy (PFS2) [Time frame: Up to approximately 4 years 5 months]
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity [Time frame: Up to approximately 4 years 5 months]
Eligibility criteria
Inclusion criteria
- Have histologically confirmed adenocarcinoma of the prostate
- Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator
- Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) (<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
- Have progressed by PSA or CT/MRI or 99m\^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Exclusion criteria
- Known history of either brain or leptomeningeal prostate cancer metastases
- Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
- Prior or concurrent second malignancy (other than the disease under study)
- Received cytotoxic chemotherapy for prostate cancer in any setting
- Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- Arizona Clinical Trials — Chandler
- Arkansas Urology — Little Rock
- MemorialCare Orange Coast Medical Center — Fountain Valley
- University Of California San Diego — La Jolla
- Cancer and Blood Specialty Clinic — Los Alamitos
- USC Norris Comprehensive Cancer Center — Los Angeles
- Valkyrie Clinical Trials — Los Angeles
- Kaiser Permanente Southern California — Riverside
- … and 43 more centers
China · 15 centers
- Beijing Cancer Hospital — Beijing
- Beijing Luhe Hospital, Capital Medical University — Beijing
- The Third People's Hospital of Chengdu — Chengdu
- West China Hospital Sichuan University — Chengdu
- Chongqing University Cancer Hospital — Chongqing
- Sun Yat Sen University Cancer Center — Guangzhou
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou
- … and 7 more centers
France · 8 centers
Center list to be confirmed — check the primary protocol.
Japan · 7 centers
Center list to be confirmed — check the primary protocol.
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 7 centers
Center list to be confirmed — check the primary protocol.
Canada · 6 centers
- British Columbia Cancer Agency — Vancouver
- British Columbia Cancer Agency Vancouver Island Centre — Victoria
- The Ottawa Hospital Cancer Centre — Ottawa
- Princess Margaret Cancer Centre — Toronto
- Centre de Recherche du CHUM — Montreal
- CHU de Quebec Universite Laval — Québec
Germany · 6 centers
Center list to be confirmed — check the primary protocol.
Italy · 6 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 6 centers
Center list to be confirmed — check the primary protocol.
Australia · 5 centers
- Warringal Private Hospital — Heidelberg
- Icon Cancer Centre Kurralta Park — Kurralta Park
- Peter MacCallum Cancer Centre — Melbourne
- Sydney Adventist Hospital — Wahroonga
- Princess Alexandra Hospital — Woolloongabba
Belgium · 5 centers
- AZORG campus Aalst Moorselbaan — Aalst
- ZAS Augustinus — Antwerp
- AZ Maria Middelares — Ghent
- Chu Helora Hospital La Louviere Site Jolimont — La Louvière
- CHC MontLegia — Liège
Brazil · 5 centers
- NAIC Nair Antunes Instituto do Cancer — Bauru
- Liga Norte Riograndense Contra O Cancer — Natal
- Hospital Ana Nery Santa Cruz do Sul — Santa Cruz do Sul
- CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia — Santo André
- ESHO Empresa De Servicos Hospitalares S A — São Paulo
Malaysia · 5 centers
Center list to be confirmed — check the primary protocol.
South Korea · 5 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 5 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07225946 · 78278343PCR3003 · 2025-522713-29-00