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 (May 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
Cancer type
Prostate Cancer
Biomarker criteria
Required: PTEN loss (IHC staining ≤10%) (IHC ≤10%)
PTEN IHC staining must be less than or equal to 10% as determined by the central lab
Disease stage
Grade: Gleason sum >7 (ISUP Grade Group >3)Gleason score 4+3=7 (ISUP Grade Group 3) (ISUP)
Any one of the following three high risk features: Gleason sum >7 (ISUP Grade Group >3); Clinical stage T3 (resectable), per AJCC Cancer Staging Manual, 8th ed.; PSA > 20 ng/ml
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antiandrogen (orchiectomy, LHRH therapy, abiraterone, ketoconazole, estrogen therapy)
Exception: Short-term ADT allowed, less than or equal to 2 months
Anti-androgen therapy including orchiectomy, 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
Cannot have received: anti-cancer monoclonal antibody
Has had a prior anti-cancer monoclonal antibody (mAb) within 30 days prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 30 days earlier
Cannot have received: chemotherapy
Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: immunotherapy
Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: targeted small molecule therapy
Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: immunosuppressant
Exception: other than corticosteroids
Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: nitrosourea
Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
Cannot have received: mitomycin C
Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
Lab requirements
Blood counts
ANC, platelets, hemoglobin
Kidney function
CrCl or eGFR
Liver function
transaminases, albumin
Cardiac function
PTT and INR (unless anticoagulated, then therapeutic range is acceptable)
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). All screening labs should be performed within 30 days of treatment initiation
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
- 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
- South Texas Health Care System, San Antonio, TX · San Antonio, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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