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Recruiting Phase 3 NCT07225946

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

Phase 3 – large-scale trial before approval
Conditions: Prostatic Neoplasms, Castration-Resistant

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
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) 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).
Who can participate
Inclusion criteria: * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of the screening 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 milliliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening * Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received 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) because the natural history or treatment could interfere with study endpoints * Received cytotoxic chemotherapy for prostate cancer in any setting * Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Locations 15
Australia (1)
Icon Cancer Centre Kurralta Park
Kurralta Park
Belgium (1)
ZAS Augustinus
Antwerp
Brazil (1)
NAIC Nair Antunes Instituto do Cancer
Bauru
Canada (1)
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
China (1)
Beijing Luhe Hospital, Capital Medical University
Beijing
France (1)
Centre Oscar Lambret
Lille
Japan (1)
Kanazawa University Hospital
Kanazawa
Malaysia (1)
Hospital Wanita dan Kanak-Kanak Sabah
Kota Kinabalu
Puerto Rico (1)
Pan American Center for Oncology Trials LLC
San Juan
South Korea (1)
National Cancer Center
Goyang-si
Spain (1)
Hosp. Univ. 12 de Octubre
Madrid
Taiwan (1)
China Medical University Hospital
Taichung
Turkey (1)
Gulhane Training and Research Hospital
Ankara
United Kingdom (1)
Velindre Cancer Centre
Cardiff
United States (1)
Arizona Clinical Trials
Chandler , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
19.12.2025
Completion date
20.07.2029
Registry ID
NCT07225946
Source
anzctr
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