Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (NCT04493853)
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.
🩺 Plain-English Summary (8th-Grade Level)
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Who can join: Review the eligibility criteria below.
Location: Research Site — Tucson, Arizona
Age range: 18 Years to 130 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (323 Sites)
Showing the first 25 of 323 sites.
- Research Site — Tucson, Arizona
- Research Site — Tucson, Arizona
- Research Site — La Jolla, California
- Research Site — Orange, California
- Research Site — San Diego, California
- Research Site — Denver, Colorado
- Research Site — Lakewood, Colorado
- Research Site — Norwich, Connecticut
- Research Site — Fort Myers, Florida
- Research Site — West Palm Beach, Florida
- Research Site — Chicago, Illinois
- Research Site — Geneva, Illinois
- Research Site — Lisle, Illinois
- Research Site — Baltimore, Maryland
- Research Site — Detroit, Michigan
- Research Site — Grand Rapids, Michigan
- Research Site — Troy, Michigan
- Research Site — Syracuse, New York
- Research Site — The Bronx, New York
- Research Site — Asheville, North Carolina
- Research Site — Durham, North Carolina
- Research Site — Columbus, Ohio
- Research Site — Lancaster, Pennsylvania
- Research Site — Philadelphia, Pennsylvania
- Research Site — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Hormone-Sensitive Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.