Pembro With Radiation With or Without Olaparib

Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer

About This Trial

  • This study is testing whether combining radiation therapy with an immune-boosting medicine, given with or without an additional targeted cancer pill, can better treat prostate cancer.
  • It is designed for men with high-risk prostate cancer that has not spread to distant parts of the body.
  • To be eligible, you must be in generally good daily health and cannot have had previous radiation treatment to your pelvis.
  • Before joining, patients should also know that any prior hormone therapy must be very limited, and you must agree to use effective birth control during and for several months after the study.

More Information

  • This trial will evaluate whether the immune-sensitizing effects of immunotherapy (Pembrolizumab) and radiation with or without a PARP-inhibitor (Olaparib) will increase the effects of immunotherapy in men with high-risk localized prostate cancer.

Who Can Enroll

  • Age Range: 18 years and older
  • Gender: Male
  • Who This Trial is For: This study is testing whether combining radiation therapy with an immune-boosting medicine, given with or without an additional targeted cancer pill, can better treat prostate cancer.

Study Details

  • Start Date: July 27, 2023
  • Lead Sponsor: Zin W Myint
Full Eligibility Criteria

Inclusion Criteria

  • Male participants with histologically confirmed adenocarcinoma of the prostate
  • High-risk / very high-risk status per NCCN guidelines
  • ECOG performance status 0 to 1
  • Regional lymph nodes are allowed.
  • Agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Adequate organ and marrow function
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤90 days prior to the date of registration
  • Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.

Exclusion Criteria

  • Prior hormonal therapy with LHRH agonists (e.g., Lupron) and LHRH antagonists (e.g., Degarelix)for prostate cancer continuously for more than 90-days prior to study enrollment.
  • Prior radiation to the prostate or pelvic nodes radiation.
  • Previous or major surgery (colorectal anastomosis, total cystectomy, etc.).
  • History of Ulcerative proctitis.
  • Concurrent active, additional malignancy in the last 2 years.
  • Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
  • Patients with M1 disease

Treatments

  • Biological: Pembrolizumab
  • Drug: Olaparib
  • Drug: Androgen Deprivation Therapy
  • Radiation: Radiation Therapy
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