Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05568550

Pembro With Radiation With or Without Olaparib

Led by Zin W Myint · Updated on 2026-01-30

64

Participants Needed

2

Research Sites

309 weeks

Total Duration

On this page

Sponsors

Z

Zin W Myint

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pembro With Radiation With or Without Olaparib

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

2

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

B

Bryan Courtney

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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