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NCT05568550 | RECRUITING | Prostate Cancer

Pembro With Radiation With or Without Olaparib
Sponsor:

Zin W Myint

Information provided by (Responsible Party):

Zin W Myint

Brief Summary:

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.

Condition or disease

Prostate Cancer

Intervention/treatment

Pembrolizumab

Olaparib

Androgen Deprivation Therapy

Radiation Therapy

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer
Actual Study Start Date : 2023-07-27
Estimated Primary Completion Date : 2026-07-02
Estimated Study Completion Date : 2029-07-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
  • * 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 M1 disease
Pembro With Radiation With or Without Olaparib

Location Details

NCT05568550

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Locations

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112