Study on Pembrolizumab with Radiation, with or without Olaparib, for High-Risk Localized Prostate Cancer

Sponsor: Zin W Myint

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05568550

Provider View

This clinical trial is testing whether combining the immunotherapy drug Pembrolizumab with radiation, and possibly adding the drug Olaparib, can enhance the treatment effects in men with high-risk localized prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if using Pembrolizumab, an immunotherapy drug, along with radiation therapy, and possibly adding Olaparib, a PARP-inhibitor, can improve treatment outcomes for men with high-risk localized prostate cancer. The study will compare two groups: one receiving Pembrolizumab with Olaparib and standard radiation and hormone therapy, and the other receiving Pembrolizumab with standard radiation and hormone therapy. All participants will continue with immunotherapy for one year after completing radiation treatment.

Description

This study is exploring the potential benefits of combining immunotherapy with a PARP-inhibitor and radiation therapy for treating high-risk localized prostate cancer. Immunotherapy and PARP-inhibitors are known to enhance the effects of radiation therapy. When used together, they may increase the expression of new antigens, attract more immune cells to the tumor, and boost immune-stimulating substances in the body. This combination could potentially work better than using these treatments separately.

The study is a phase 2 trial where participants are randomly assigned to one of two groups. One group will receive Pembrolizumab, Olaparib, and standard radiation and hormone therapy. The other group will receive Pembrolizumab and standard radiation and hormone therapy. After completing radiation treatment, all participants will continue with immunotherapy for one year.

Eligibility Criteria

Inclusion Criteria

  • Men diagnosed with prostate cancer confirmed by lab tests.
  • Classified as high-risk or very high-risk according to specific medical guidelines.
  • In good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • No pelvic lymph nodes larger than 2 cm as shown by CT scans.
  • Agree to use contraception during the study and for at least 120 days after the last treatment, and not donate sperm during this time.
  • Able to understand and willing to sign a consent form.
  • Have adequate organ and bone marrow function.
  • Previous hormone therapy for prostate cancer is allowed if started within 90 days before joining the study.
  • Previous use of 5-alpha reductase inhibitors for prostate issues is allowed if stopped at least 60 days before joining the study.
  • If there is a history of heart disease or treatment with heart-damaging drugs, a heart function assessment is required.

Exclusion Criteria

  • PSA level greater than 150 ng/ml.
  • Previous hormone therapy for more than 90 days before joining the study.
  • Previous radiation to the prostate or major pelvic surgery.
  • History of ulcerative proctitis.
  • Another active cancer within the last 2 years.
  • Previous cancer treatments, including experimental drugs, within 4 weeks before joining the study.
  • Cancer that has spread to distant parts of the body.

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