Last updated 18 days ago
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
960 patients around the world
Available in Puerto Rico, Chile, Brazil, Argentina
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).
Celgene
7Research sites
960Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- 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).
- 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.
Sites
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Instituto Multidisciplinario de Oncología - CIC - Clínica Viedma, Río Negro.
Recruiting
Hospital Privado de Córdoba
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
StudyrechARge
SponsorCelgene
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT06764485
