OncoMatch/Clinical Trials/NCT05593497
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
Is NCT05593497 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Capivasertib and abiraterone acetate for high-risk prostate cancer.
Treatment: Capivasertib · abiraterone acetate — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Prostate Cancer
Biomarker criteria
Required: PTEN loss (<=10% by ihc)
Disease stage
Required: Stage HIGH-RISK LOCALIZED (other)
Excluded: Stage IV
Gleason sum >7 (ISUP Grade Group >3); Clinical stage T3 (resectable); PSA > 20 ng/ml; High risk features
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: antiandrogen (orchiectomy, luteinizing hormone-releasing hormone (LHRH) therapy, abiraterone, ketoconazole, estrogen therapy)
Exception: Short-term ADT allowed, less than or equal to 2 months
Anti-androgen therapy including orchiectomy, luteinizing hormone-releasing hormone (LHRH) therapy, abiraterone, ketoconazole, estrogen therapy (Short-term ADT allowed, less than or equal to 2 months)
Cannot have received: radiation therapy (external beam, brachytherapy)
Radiation (external beam or brachytherapy)
Cannot have received: cytotoxic chemotherapy
Cytotoxic chemotherapy
Cannot have received: focal or ablative therapy
Focal or ablative therapy
Cannot have received: experimental therapy
Any experimental therapy for treatment of prostate cancer
Lab requirements
Blood counts
ANC, platelets, hemoglobin
Kidney function
CrCl or eGFR
Liver function
transaminases, albumin
Demonstrate adequate organ function as defined by laboratory parameters including ANC, platelets, hemoglobin, transaminases, albumin, hemoglobin A1C, CrCl or eGFR, PTT and INR (unless anticoagulated, then therapeutic range is acceptable).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05593497 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require PTEN?
Yes, PTEN loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage HIGH-RISK LOCALIZED is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages