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Recruiting Phase 3 NCT07164443

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

Trial Parameters

Condition Metastatic Castration-resistant Prostate Neoplasms
Sponsor Janssen Research & Development, LLC
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 663
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2025-09-02
Completion 2028-05-30
Interventions
PasritamigPlaceboBest Supportive Care (BSC)

Brief 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).

Eligibility Criteria

Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate * Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening * PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL) at screening * In the opinion of the investigator, the next best treatment option is a clinical trial * Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI Taxanes: Should have received at least 2 previous taxane-based regime

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