Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

Summary:

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

Trial Description

Primary Outcome:

  • Investigator-Assessed Radiographic Progression-Free Survival (rPFS)
Secondary Outcome:
  • Time to Pain Progression
  • Time to Initiation of Cytotoxic Chemotherapy
  • Overall Survival
  • Time to Function Deterioration
  • Time to Prostate-Specific Antigen (PSA) Progression
  • Time to First Opioid Use
  • Time to Symptomatic Skeletal Event (SSE)
  • Objective Response Rate (ORR)
  • PSA Response Rate
  • Investigator-Assessed rPFS in Participants With PTEN-Loss Tumours by Next-Generation Sequencing (NGS)
  • Plasma concentration of ipatasertib
  • Plasma concentration of abiraterone

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society