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Pembrolizumab and Radiation with Olaparib for High-Risk Prostate Cancer

This study is for men with high-risk prostate cancer. It is testing if combining Pembrolizumab (an immunotherapy) and radiation therapy with Olaparib (a PARP inhibitor) can improve treatment. All participants will receive Pembrolizumab through an IV for about 12 months, and Olaparib by mouth twice daily for 3 cycles. These treatments start before and continue during and after radiation therapy. You will also receive standard hormone therapy (Androgen Deprivation Therapy). The study aims to see how many participants respond to this treatment after 6 months. To join, you must be a man aged 18 or older with confirmed prostate cancer that is high-risk or very high-risk. The study plans to enroll 64 participants.

Study design
This is a single-arm study, meaning all 64 participants will receive the same combination of treatments. It is a Phase 2 study, which means it is further evaluating the safety and effectiveness of the treatments.
What's involved
You will receive Pembrolizumab via IV for about 12 months and Olaparib twice daily for 3 cycles, starting before radiation therapy. You will also undergo radiation therapy and receive hormone therapy. The study will measure your clinical response at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, clinical response rate, is measured at 6 months. The duration of follow-up beyond this is not specified.

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NCT05568550

Pembro With Radiation With or Without Olaparib

Recruiting
PHASE2Ages 18+InterventionalTreatment
Zin W Myint
~64 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:PembrolizumabOlaparibAndrogen Deprivation TherapyRadiation Therapy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Response Rate
Measured over 6 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 2 states
Kentucky1
Utah1

Study leadership

  • Zin W Myint, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Bryan Courtney
[email protected]
859-257-3379
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Clinical Response Rate6 months

    The proportion of patients who achieve a PSA nadir level of ≤ 0.06ng/mL six months after completion of radiation therapy.