Combining immunotherapy and radiation for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of Pembrolizumab, an immunotherapy drug, combined with radiation therapy, with or without the addition of Olaparib, a PARP-inhibitor, in men with high-risk localized prostate cancer. The study aims to determine if this combination enhances the immune response and improves treatment outcomes compared to standard care. Participants will be randomly assigned to receive either the combination treatment or standard care alone, with all subjects receiving adjuvant immunotherapy for one year after radiation. The trial focuses on leveraging the immune-sensitizing effects of these therapies to potentially improve patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Active not recruiting

Study contacts

• Principal investigator: Zin W Myint, MD — University of Kentucky
• Study coordinator: Bryan Courtney
• Email: bryancourtney@uky.edu
• Phone: 859-257-3379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hormone therapy with darolutamide and pembrolizumab before prostate removal, then pembrolizumab after surgery for high-risk prostate cancer

  This trial will test whether giving androgen-deprivation therapy plus darolutamide and pembrolizumab before prostate removal, followed by pembrolizumab after surgery, helps men with genomically defined high-risk localized prostate cancer.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07027124

• Combining pembrolizumab with targeted radionuclide therapy for advanced prostate cancer

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  Recruiting Phase 2 University of California, San Francisco · San Francisco, California · NCT05766371

• Combining radiation therapy and immunotherapy for advanced prostate cancer

  This study is testing if combining a targeted radiation treatment with an immunotherapy and a hormone therapy can help men with advanced prostate cancer feel better and improve their outcomes.

  Recruiting at 3 sites Phase 1/2 Weill Medical College of Cornell University · Boston, Massachusetts and 3 other locations · NCT04946370

• Pembrolizumab plus intensive androgen-blocking before prostatectomy for high-risk localized prostate cancer

  This trial tests whether giving pembrolizumab together with intensive androgen-blocking (enzalutamide) before prostatectomy helps men with high-risk localized prostate cancer.

  Recruiting Phase 2 Portland VA Medical Center · Portland, Oregon · NCT03753243

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

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• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.