Recruiting
Phase 2

Pembro with Radiation

Sponsor:

Zin W Myint

Code:

NCT05568550

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Olaparib

Androgen Deprivation Therapy

Radiation Therapy

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT05568550

Start date

Jul 27, 2023

Status verified date

Jul, 2026

Completion date

Jul 2, 2029

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Pembrolizumab and Olaparib

Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.

experimental: Arm 2 - Pembrolizumab

Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.

Interventions

Pembrolizumab

Pembrolizumab will be delivered via IV at 200mg on day 1 of each 3-week cycle for approximately 12 months. Cycle 1 begins 21 days prior to radiation therapy and cycles 2-17 are administered during and after radiation therapy.

Olaparib

200mg Olaparib will be given twice daily for a total of 3 cycles. Cycle 1 begins 21-days prior to radiation therapy.

Androgen Deprivation Therapy

Androgen Deprivation Therapy (either LHRH agonist or LHRH antagonist) as per treating physician choice will be allowed within 3 months prior to randomization. Duration is per institutional standards.

Radiation Therapy

Definitive radiation (total dose and fractions) will be dosed per institutional standards. Definitive radiation may include external beam radiation therapy with or without brachytherapy, based on NCCN risk score and as per treating physicians.

Primary outcome measure

  • Clinical Response Rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Bryan Courtney

859-257-3379bryancourtney@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Bryan Courtney, RN,CCRC

859-257-5207bryancourtney@uky.edu

Zin Myint, MD

859-323-3964zin.myint@uky.edu

More Information

Sponsor

Zin W Myint

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • immunotherapy
  • PARP
  • radiation
  • androgen deprivation therapy
  • ADT
  • PD-1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zin W Myint on 2026-07-14.