Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-22-008
Prinicipal Investigator
Joshi, Monika
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
D361EC00001
Title
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
Objective
Primary Objective is to demonstrate superiority of capivasertib +docetaxel relative to placebo + docetaxel by assessment of overall survival (OS) in patients with mCRPC. Key secondary is to demonstrate superiority of capivasertib + docetaxel relative to placebo + docetaxel by assessment of radiographic progression free survival (rPFS) in patients with mCRPC; To demonstrate superiority of capivasertib + docetaxel relative to placebo + docetaxel by assessment of time to pain progression (TTPP) in patients with mCRPC.
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
Hershey Medical Center