NCT05593497 · VA Office of Research and Development
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
(SNARE)
What this study is about
The purpose of this study is to learn about how an experimental 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.
View original scientific description
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.
Interventions
DRUG
Capivasertib
400 mg (2 tablets) BID given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week (4 days on, 3 days off). Treatment will be given in combination with abiraterone for 16 weeks duration (+/- 1 week for surgery window).
DRUG
abiraterone acetate
Administered orally as tablets at a dosage of 1000 mg daily. To be administered with prednisone 5mg po daily. Subjects will be on concurrent GNRH agonist therapy (leuprolide, administered as standard of care). Intensified androgen deprivation (iADT) consisting of abiraterone and leuprolide will be administered for a 4 week run-in prior to addition of capivasertib.
Primary outcome measures
Pathologic Complete Response or Minimal Residual Disease (MRD)
Time frame: 5 months
No cancer detected on radical prostatectomy specimen, or minimal residual disease 5mm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age greater than or equal to 18 years. Members of all races and ethnic groups will be included. 3. Participants must have histologically confirmed non-metastatic adenocarcinoma of the prostate 4. (a) 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 oSubjects who meet high risk criteria solely by PSA (i.e., stage \<T3 AND Gleason sum less than or equal to 7) must have a progression-free probability after radical prostatectomy that is less than or equal to 50% at 5 years as estimated by the Memorial Sloan Kettering (MSK) pre-radical prostatectomy nomogram: https://www.mskcc.org/nomograms/prostate/pre\_op (b) Subjects not meeting high ris
Where
- West Los Angeles, California
- The Bronx, New York
- Portland, Oregon
- Charleston, South Carolina
- San Antonio, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations