Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Official 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)

Summary:

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Radiographic Progression-free Survival (rPFS)
  • Time to pain progression (TTPP)
  • Time to first Symptomatic Skeletal-Related Event (SSRE)
  • Time to deterioration in urinary symptoms (TTDUS)
  • Time to deterioration in Physical Functioning (TTDPF)
  • Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
  • Plasma concentration of capivasertib derived from a population PK model

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