New combo therapy aims to knock out high-risk prostate cancer
NCT ID NCT05568550
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study is for men with high-risk prostate cancer that hasn't spread. It tests whether adding an immunotherapy drug (pembrolizumab) and a targeted drug (olaparib) to standard radiation therapy can better control the cancer. About 64 participants will receive the combination and be monitored for treatment response and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huntsman Cancer Institute
ACTIVE_NOT_RECRUITINGSalt Lake City, Utah, 84112, United States
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University of Kentucky
RECRUITINGLexington, Kentucky, 40536, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains