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NCT05568550RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
64 (estimated)
First submitted
29 Sept 2022
Start date
27 Jul 2023
Primary completion date
2 Dec 2027
Lead sponsor
Zin W Myint
NCT number
NCT05568550

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 64
  • From 27 Jul 2023 to the primary completion date, 2 Dec 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.).
  • Concurrent active, additional malignancy in the last 2 years.
  • Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.

Other illness

  • History of Ulcerative proctitis.
  • Patients with M1 disease

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Huntsman Cancer Institute
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.