Skip to content

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator’s Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517422-25-00
Acronym
CA071-1000
Enrollment
374
Registered
2025-05-02
Start date
2025-05-22
Completion date
Unknown
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Brief summary

rPFS (for radiographic progression-free survival) by BICR (Blinded Independent Central Review). The ability of BMS-986365 to work better than other treatments chosen by the doctors is tested by looking at the rPFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like X-rays or scans)

Detailed description

OS (Overall Survival) This study will assess if people live longer when they take BMS-986365 compared to other treatments chosen by the doctors. This is what is called "Overall Survival".

Interventions

DRUGDOCETAXEL
DRUGABIRATERONE
DRUGPREDNISOLONE
DRUGPREDNISONE
DRUGENZALUTAMIDE

Sponsors

Celgene Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
rPFS (for radiographic progression-free survival) by BICR (Blinded Independent Central Review). The ability of BMS-986365 to work better than other treatments chosen by the doctors is tested by looking at the rPFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like X-rays or scans)

Secondary

MeasureTime frame
OS (Overall Survival) This study will assess if people live longer when they take BMS-986365 compared to other treatments chosen by the doctors. This is what is called "Overall Survival".

Countries

Austria, Czechia, Denmark, France, Germany, Ireland, Italy, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026