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Recruiting Phase 3 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 3 – large-scale trial before approval
Conditions: Metastatic Castration-resistant Prostate Cancer

Sponsor: Celgene

trial.available_in: БГ
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.
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).
Who can participate
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.
Locations 24
Argentina (1)
Hospital Británico de Buenos Aires
CABA , Buenos Aires
Ernesto Korbenfeld, Site 0125
Australia (1)
GenesisCare - Campbelltown
Campbelltown , New South Wales
Felicia Roncolato, Site 0366
Brazil (1)
Local Institution - 0039
Vitória , Espírito Santo
NOT_YET_RECRUITING
Canada (1)
BC Cancer Kelowna
Kelowna , British Columbia
Chile (1)
Oncocentro Valdivia
Valdivia , Los Ríos Region
Maria Herrera, Site 0236
China (1)
Second Affiliated hospital of Anhui Medical University
Hefei , Anhui
dexin yu, Site 0232
Czech Republic (1)
Local Institution - 0011
Hořovice , Beroun
WITHDRAWN
Denmark (1)
Herlev and Gentofte Hospital
Copenhagen , Capital Region
Rasmus Bisbjerg, Site 0243
France (1)
Centre Antoine-Lacassagne
Nice , Alpes-Maritimes
Delphine Borchiellini, Site 0167
India (1)
Local Institution - 0404
Thiruvananthapuram , Kerala
NOT_YET_RECRUITING
Ireland (1)
Cork University Hospital
Cork
Jack Gleeson, Site 0271
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , Lombardy
Giuseppe Procopio, Site 0157
Japan (1)
Local Institution - 0451
Nagoya , Aichi-ken
NOT_YET_RECRUITING
Poland (1)
Pratia Poznań
Poznan , Greater Poland Voivodeship
Marek Kotlarski, Site 0365
Puerto Rico (1)
BRCR Global - Mayagüez
Mayagüez
Maryangely Moreno Campa, Site 0117
Romania (1)
Centrul de Oncologie "Sfântul Nectarie"
Craiova , Dolj
Michael Schenker, Site 0139
Slovakia (1)
MILAB
Prešov , Presov
Ivan Mincik, Site 0381
South Korea (1)
National Cancer Center
Goyang-si , Kyǒnggi-do
Jae Young Joung, Site 0389
Spain (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
MARIA JOSE MENDEZ VIDAL, Site 0312
Sweden (1)
Skånes Universitetssjukhus Lund
Lund , Skåne Län [se-12]
Olof Staahl, Site 0099
Taiwan (1)
China Medical University Hospital
Taichung
Hsi-Chin Wu, Site 0398
Turkey (1)
Local Institution - 0340
Adana
NOT_YET_RECRUITING
United Kingdom (1)
The Beatson West of Scotland Cancer Centre
Glasgow , Glasgow City
Robert Jones, Site 0393
United States (1)
Central Alabama Research
Birmingham , Alabama
David Mooney, Site 0330
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
13.03.2025
Completion date
19.01.2029
Registry ID
NCT06764485
Source
anzctr
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