RecruitingPhase 2

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

UT