Study on Pre-Surgery Treatment with Hormone and AKT Inhibitor for High-Risk Localized Prostate Cancer with PTEN Loss

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05593497

Provider View

This clinical trial is exploring a new treatment approach for high-risk localized prostate cancer that involves using hormone therapy and an AKT inhibitor before surgery. The study aims to see if this combination can effectively shrink tumors and improve outcomes for patients with prostate cancer that has lost the PTEN gene.

Patient Parameters

Program Overview

The study is testing a new treatment method for high-risk localized prostate cancer that involves taking hormone therapy drugs (abiraterone and leuprolide) along with an AKT inhibitor (capivasertib) before undergoing prostate surgery. This approach is being evaluated to see if it can help shrink and destroy prostate cancer tumors more effectively than standard treatments, especially in cases where the cancer has lost the PTEN gene, which makes it more resistant to traditional therapies.

Description

Prostate cancer is a leading cause of cancer deaths among men in the U.S. Traditional treatments depend on the cancer's stage, PSA levels, and tumor grade. High-risk prostate cancers often lose the PTEN gene, which leads to increased AKT activity and makes the cancer more likely to return or spread. This study focuses on using hormone therapy and an AKT inhibitor to target these aggressive cancers before surgery.

The trial involves a single group of patients receiving intensified hormone therapy (abiraterone and leuprolide) combined with an AKT inhibitor (capivasertib) before prostate surgery. The goal is to reduce the amount of cancer present at the time of surgery and improve long-term outcomes.

Eligible patients will first receive hormone therapy for four weeks, followed by a biopsy to study the tumor. Then, they will undergo 16 weeks of combined hormone and AKT inhibitor treatment before having prostate surgery. The effectiveness of this treatment will be assessed by examining the cancer tissue removed during surgery.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Age 18 years or older, inclusive of all races and ethnic groups.
  • Must have confirmed non-metastatic prostate cancer.
  • Must have one of the following high-risk features:
    • Gleason score greater than 7
    • Clinical stage T3 (resectable)
    • PSA greater than 20 ng/ml
  • No evidence of cancer spread on bone scan.
  • No large lymph nodes on pelvic CT scan.
  • Surgery planned as primary treatment.
  • Willing to provide a recent tumor biopsy sample.
  • Tumor must show PTEN loss (10% or less staining).
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy greater than 10 years.
  • Minimum body weight of 45 kg and BMI of 18.5.
  • Men must use condoms during and after treatment if sexually active.
  • Able to swallow oral medication.
  • Adequate organ function based on lab tests.

Exclusion Criteria

  • Severe or uncontrolled health conditions that make participation unsafe.
  • Active hepatitis or HIV infection.
  • History of drug or alcohol abuse within 6 months.
  • Previous prostate cancer treatments like hormone therapy or radiation.
  • History of another cancer unless treated and inactive for 5 years.
  • Heart conditions that increase risk of complications.
  • Uncontrolled diabetes or high blood sugar.
  • Digestive issues that affect medication absorption.
  • Psychiatric or substance abuse disorders affecting study compliance.
  • Recent major surgery or injury.
  • Participation in another study within 30 days.
  • Allergies to study drugs or similar medications.
  • Unable to undergo required biopsy for study.

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