Prostate

TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06764485
TYPE(S) DE CANCER Prostate
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Frédéric Pouliot
COORDONATEUR(RICE) Marilyn Savard
Marilyn.Savard@crchudequebec.ulaval.ca
418-525-4444 poste 20414
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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).
CRITÈRES D'EXCLUSION (EN)
  • 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.