Pembro With Radiation With or Without Olaparib
Recruiting now · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05568550
- Run by
- Zin W Myint
- People needed
- 64
- Starts
- 2023-07-27
- Expected to finish
- 2029-07-02
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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