Pembro With Radiation With or Without Olaparib

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Zin W Myint
Study ID
NCT05568550
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    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 — DRUG
    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 — DRUG
    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 — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 27, 2023
Status verified
Jan 2026
Primary completion
Jul 2, 2026
Completion
Jul 2, 2029

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Clinical Response Rate [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Yvonne Taul, RN,CCRC
[email protected]
859-323-2354
Zin Myint, MD
[email protected]
410236809
Huntsman Cancer InstituteSalt Lake CityUtah84112
Benjamin Maughan, MD, PharmD
[email protected]
801-581-2267

Find similar trials in Lexington, KY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Kentucky· Lexington, KYHuntsman Cancer Institute· Salt Lake City, UT

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