Combining immunotherapy and radiation for high-risk prostate cancer
Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer
This study is testing if combining an immunotherapy drug with radiation, and possibly adding another medication, can help men with high-risk prostate cancer do better than with standard treatment alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation, Pembrolizumab, immunotherapy |
| Locations | 2 sites (Lexington, Kentucky and 1 other locations) |
| Trial ID | NCT05568550 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are male patients with histologically confirmed high-risk or very high-risk prostate cancer.
Not a fit: Patients with low-risk prostate cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment efficacy for men with high-risk localized prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and radiation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky and 1 other locations
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Zin W Myint, MD — University of Kentucky
- Study coordinator: Bryan Courtney
- Email: bryancourtney@uky.edu
- Phone: 859-257-3379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.