Home › Prostate Cancer › NCT05568550
Pembro With Radiation With or Without Olaparib
RecruitingPhase 2
Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer
Who can join
Ages 18 and older · Men
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
About the study
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.
What is being tested
- Pembrolizumab (biological)
- Olaparib (drug)
- Androgen Deprivation Therapy (drug)
- Radiation Therapy (radiation)
Sponsor: Zin W Myint · Participants: 64 · Started: Jul 27, 2023
Contact the study team
- Bryan Courtney · Phone: 859-257-3379
Official record on ClinicalTrials.gov — NCT05568550
Locations in the U.S.
| Kentucky | University of Kentucky, Lexington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.