Pembro With Radiation With or Without Olaparib

Description

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.

Conditions

Prostate Cancer

Study Overview

Study Details

Study 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.

Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer

Pembro With Radiation With or Without Olaparib

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Salt Lake City

Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zin W Myint,

Zin W Myint, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2029-07-02