Recruiting NCT06764485

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

Phase III Interventional 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: BMS-986365, Enzalutamide, Abiraterone, Docetaxel.
Who it may be relevant to: Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
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, Argentina, Australia, Austria, Brazil +21
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, 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

Overview

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

Detailed description

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.

In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).

Interventions

Drug BMS-986365
Specified dose on specified days
Drug Enzalutamide
Specified dose on specified days
Drug Abiraterone
Specified dose on specified days
Drug Docetaxel
Specified dose on specified days
Drug Predinsone/Prednisolone
Specified dose on specified days

Primary outcome measures

Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria [Time frame: Up to 4 years]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to 4 years]
Recommended dose of BMS-986365 for Part 2 [Time frame: Up to approximately 1.5 years]
Progression-free survival (PFS) [Time frame: Up to 4 years]
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria [Time frame: Up to 4 years]
Time to pain progression (TTPP) [Time frame: Up to 4 years]
Time to symptomatic progression (TTSP) [Time frame: Up to 4 years]
Time to initiation of the first subsequent systemic therapy (TFST) [Time frame: Up to 4 years]
Prostate-specific antigen (PSA) response rate [Time frame: Up to 4 years]
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores [Time frame: Up to 4 years]
Change from baseline in Prostate Cancer Subscale (PCS) scores [Time frame: Up to 4 years]
Change from baseline in trial outcome index (TOI) [Time frame: Up to 4 years]
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion criteria

Participants must not have impaired cardiac function or clinically significant cardiac disease.
Participants must not have any brain metastasis.
Participants must not have any liver metastasis.
Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
Other protocol-defined Inclusion/Exclusion criteria apply.

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