Groupe d'Etude en Oncologie du Quebec

Titre	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
Protocole ID	rechARge
ClinicalTrials.gov ID	NCT06764485
Type(s) de cancer	Prostate
Phase	Phase III
Type étude	Clinique
Médicament	BMS-986365 versus thérapie au choix de l'investigateur
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Ramy Saleh
Coordonnateur(trice)
Statut	Actif en recrutement
Critètes d'éligibilité	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).
Critètes d'exclusion	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.

Groupe d'étude en oncologie du Québec