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 CISSS DU BAS-SAINT-LAURENT
   HOPITAL REGIONAL DE RIMOUSKI
      150 av. Rouleau, Rimouski, QC, G5L 5T1
Ville Rimouski
Investigateur(trice) principal(e) Dr Samuel Nadeau
Coordonnateur(trice) Isabelle Gagnon
 418-724-3000 poste 8029
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.