A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (NCT05593497)
Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.
Who can join: Review the eligibility criteria below.
Location: VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California
Age range: 18 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 (9 Sites)
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York
- VA Portland Health Care System, Portland, OR — Portland, Oregon
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (503) 220-8262
Email: ryan.kopp@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.