RecruitingPhase 2NCT05593497

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

Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss

Sponsor

VA Office of Research and Development

Enrollment

30 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

High-risk Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of hormone-blocking therapy (leuprolide and abiraterone) with a targeted drug called capivasertib before surgery in men with high-risk prostate cancer that has a specific genetic feature called PTEN loss. The goal is to shrink the cancer before it is surgically removed. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with prostate cancer (non-metastatic) confirmed by biopsy - Your cancer is classified as high-risk: either a Gleason score above 7, a PSA above 20, or cancer that has grown into nearby tissue (T3 stage) - Your tumor has been tested and shows PTEN loss **You may NOT be eligible if...** - You have severe uncontrolled medical conditions (such as uncontrolled high blood pressure, serious kidney or liver problems, or active infection) - You have other conditions your doctor believes would make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapivasertib

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).

DRUGabiraterone 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.