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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All subjects will receive adjuvant immunotherapy for one year once they are done with definitive radiation treatment."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests pembrolizumab, a drug that helps the immune system fight cancer, with radiation, with or without olaparib. It is for men with high-risk prostate cancer that has not spread to distant parts of the body.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men with prostate adenocarcinoma, a type of prostate cancer confirmed by a tissue test.
- Cancer must be high-risk or very high-risk under NCCN guidelines. Spread to nearby lymph nodes is allowed.
- Must be fully active or able to do light work, even if hard physical activity is limited.
- Must use birth control and not donate sperm during treatment and for at least 120 days after the last study dose.
- Must understand the study and be willing to sign a consent form.
- Organs and bone marrow, which makes blood cells, must work well enough.
- Prior medicine to lower male hormones is allowed only if started within 90 days before study registration.
- People with heart disease, heart symptoms, or past treatment that can harm the heart need a heart function check.
Who can't join
- Continuous hormone treatment for prostate cancer, such as Lupron or Degarelix, for more than 90 days before joining.
- Past radiation to the prostate or lymph nodes in the pelvis.
- Previous or major surgery, such as surgery to reconnect the bowel or remove the bladder.
- A history of ulcerative proctitis, which causes sores and swelling in the rectum.
- Another active cancer within the past 2 years.
- Cancer drugs that treat the whole body, including experimental drugs, within 4 weeks before study group assignment.
- Cancer that has spread to distant parts of the body.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (2)
KY
- University of Kentucky · Lexington, KY 40536Bryan Courtney, RN,CCRC · Study contact · 859-257-5207 · bryancourtney@uky.eduZin Myint, MD · Study contact · 859-323-3964 · zin.myint@uky.eduMore trials in Lexington
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112More trials in Salt Lake City