Study on Pembrolizumab and Androgen Blockade Before Surgery for High-Risk Localized Prostate Cancer

Sponsor: Mark Garzotto, MD

Sponsor score: 0

ClinicalTrials ID:NCT03753243

Provider View

This clinical trial is testing a combination of pembrolizumab and androgen-blocking medication given before surgery to see if it can effectively treat high-risk localized prostate cancer.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of using pembrolizumab, an immunotherapy drug, together with androgen-blocking medication before prostate surgery in patients with high-risk localized prostate cancer. Pembrolizumab is given as an IV infusion every three weeks, and enzalutamide is taken orally every day. The goal is to see if this combination can eliminate cancer cells in the prostate before surgery.

Description

This trial is designed to test the effects of combining pembrolizumab, an immune therapy, with intensive androgen receptor targeting before prostate surgery in patients with high-risk localized prostate cancer. The study is a single-arm, open-label Phase II trial, meaning all participants receive the same treatment, and both the researchers and participants know what treatment is being given. The main goal is to see if this treatment can completely eliminate cancer cells in the prostate tissue removed during surgery. Participants will receive pembrolizumab through an IV infusion every three weeks and take enzalutamide orally every day. The study will assess the safety and effectiveness of this treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate in the trial.
  • Be 18 years or older.
  • Have prostate cancer that has not spread to other parts of the body.
  • Plan to have prostate surgery with extended lymph node removal as the main treatment.
  • Have a life expectancy of 10 years or more based on other health conditions.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one high-risk feature, such as:
    • Gleason grade greater than 8-10
    • PSA level greater than 20 ng/ml
    • Clinical stage T3a (resectable)
  • No evidence of cancer spread (metastases).
  • No other cancer diagnosis, except for non-melanoma skin cancer or a cancer diagnosed 5 or more years ago.
  • Male participants must agree to use effective contraception during the study and until surgery. Abstinence is acceptable if it is the participant's usual lifestyle.
  • Have adequate organ function, with all necessary lab tests done within 30 days before starting treatment.

Locations

FACILITYZIPCITYSTATE
VA Portland Healthcare System97239PortlandOregon

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