Actively Recruiting

Phase 2
Age: 18Years +
MALE
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

Led by VA Office of Research and Development · Updated on 2026-03-27

30

Participants Needed

6

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and agreement to study requirements
  • Male age 18 years or older
  • Histologically confirmed non-metastatic adenocarcinoma of the prostate
  • High risk prostate cancer defined by one or more: Gleason score above 7, clinical stage T3 (resectable), or PSA over 20 ng/ml
  • If high risk only by PSA, estimated 5-year progression-free probability after surgery must be 50% or less by MSK nomogram
  • No evidence of metastasis on bone scan
  • No lymph nodes larger than 2 cm on pelvic CT if PSA over 20 ng/ml
  • Planned radical prostatectomy with extended lymph node dissection as primary treatment
  • Willingness to provide tumor tissue from biopsy within 6 months before treatment
  • Tumor tissue must show PTEN IHC staining of 10% or less
  • ECOG performance status of 0 or 1 with no recent decline
  • Life expectancy over 10 years
  • Minimum weight 45 kg and BMI at least 18.5
  • Non-sterile men who intend to be sexually active with women of childbearing potential must use condoms during study and for 16 weeks after last dose
  • Able and willing to take and keep oral medication
  • Adequate organ function based on recent lab tests
Not Eligible

You will not qualify if you...

  • Serious or uncontrolled systemic diseases that make participation unsafe
  • Other medical or lab conditions that contraindicate study drugs or interfere with results
  • Active hepatitis B or C infection, HIV with low CD4 count, or active tuberculosis
  • History of drug or alcohol abuse in past 6 months
  • Prior prostate cancer treatments including anti-androgens (except short-term ADT), radiation, chemotherapy, focal therapies, or experimental treatments
  • Other primary cancers within 5 years except certain treated skin cancers
  • Significant cardiac issues including abnormal ECG, arrhythmias, recent heart attack or heart failure, uncontrolled blood pressure
  • Diabetes requiring insulin or poorly controlled blood sugar
  • Severe gastrointestinal problems affecting drug absorption
  • Psychiatric or substance abuse disorders interfering with study compliance
  • Previous bone marrow or organ transplant
  • Recent major surgery or injury unless recovered
  • Participation in other investigational drug studies recently
  • Recent use of monoclonal antibodies, chemotherapy, immunotherapy, or related treatments with unresolved side effects
  • Use of certain drugs affecting study drug metabolism or safety
  • Known allergy to study drugs or related compounds
  • Contraindications to abiraterone or leuprolide
  • Unable to undergo research biopsy
  • Investigator judgment that participant is unlikely to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States, 90073-1003

Actively Recruiting

2

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States, 10468-3904

Actively Recruiting

3

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97207-2964

Actively Recruiting

4

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States, 29401-5703

Actively Recruiting

5

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States, 78229-4404

Terminated

6

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States, 98108-1532

Actively Recruiting

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Research Team

R

Ryan P Kopp, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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