NCT07225946 A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT07225946 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Prostatic Neoplasms, Castration-Resistant |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-11-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 800 participants in total. It began in 2025-12-19 with a primary completion date of 2027-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07225946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostatic Neoplasms, Castration-Resistant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225946 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 800 participants.
Is NCT07225946 currently recruiting?
Yes, NCT07225946 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07225946 trial being conducted?
This trial is being conducted at Chandler, United States, Little Rock, United States, Fountain Valley, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT07225946 clinical trial?
NCT07225946 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 800 participants.