Pembro With Radiation With or Without Olaparib
Sponsor: Zin W Myint
ClinicalTrials ID:NCT05568550
This phase 2 trial assesses the synergy of Pembrolizumab with radiation, with or without Olaparib, in high-risk prostate cancer. Eligible males must meet specific health criteria. Interventions include Pembrolizumab IV, Olaparib, androgen deprivation, and radiation therapy. Participants receive adjuvant immunotherapy post-radiation for one year.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Description
Immunotherapy and PARP-inhibitor are known to have radio-sensitizing effects when combined with radiation therapy. In addition, the combination with PARP-inhibitor and radiation can increase neoantigen expression, cytotoxic lymphocyte infiltration within the tumor microenvironment and increased immune stimulating cytokine concentration. Thus, there is a potential synergy of combining immunotherapy and PARP-inhibitor.
This is a phase 2 randomized 1:1 study. Subjects will be randomized to one arm (pembro + PARPi + standard of care therapy which is definitive radiation therapy combined with hormonal therapy) vs. another arm (pembro + standard of care therapy). All subjects will receive adjuvant immunotherapy for one year once they are done with definitive radiation treatment.
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
- No pelvic nodes >2 cm in long axis as established by CT imaging
- 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
- Prior 5-alpha reductase inhibitor (for example, finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to 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
- PSA > 150ng/ml
- 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. Previous pelvic RT or major surgery (colorectal anastomosis, total cystectomy, radical prostatectomy, TURP, 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 distant metastases
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Kentucky | 40536 | Lexington | Kentucky |
| Huntsman Cancer Institute | 84112 | Salt Lake City | Utah |
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