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Prostate CancerPhase 2NCT05568550

Pembro With Radiation With or Without Olaparib

A Phase 2 study testing Pembrolizumab, Olaparib and Androgen Deprivation Therapy in people with Prostate Cancer, run by Zin W Myint at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Pembrolizumab, Olaparib and Androgen Deprivation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesUnited States
Study dates
27 Jul 2023to 2 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bryan Courtney contact

859-257-3379

bryancourtney@uky.edu

United States2 sites, 1 recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Bryan Courtney, RN,CCRC, 859-257-5207, bryancourtney@uky.edu

    Zin Myint, MD, 859-323-3964, zin.myint@uky.edu

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Active, not recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Due to slow accrual and feasibility concerns, the protocol was modified to single arm phase II study. All patients will receive definitive radiation therapy combined with ADT per institutional standards. In addition to concurrent ADT and radiation therapy, patients on this trial will also receive as follow: Pembrolizumab (17 cycles) combined with olaparib (the first three cycles). The remaining patients will be enrolled to Arm 1 only (i.e., Arm 2 usual care is closed to accrual upon Amendment 5 protocol).

Conditions
Prostate Cancer
Being tested
Pembrolizumab, Olaparib, Androgen Deprivation Therapy, Radiation Therapy
Keywords
immunotherapy, PARP, radiation, androgen deprivation therapy, ADT, PD-1
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called Keytruda

    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.

  • OlaparibDrug

    Also called Lynparza

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

  • Androgen Deprivation TherapyDrug

    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 TherapyRadiation

    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 groups in NCT05568550
Study groupRoleWhat they receive
Arm 1 - Pembrolizumab and OlaparibExperimentalPatients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.
Receives: Biological: Pembrolizumab; Drug: Olaparib; Drug: Androgen Deprivation Therapy; Radiation: Radiation Therapy
Arm 2 - PembrolizumabExperimentalPatients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.
Receives: Biological: Pembrolizumab; Drug: Androgen Deprivation Therapy; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response Rate

    The proportion of patients who achieve a PSA nadir level of ≤ 0.06ng/mL six months after completion of radiation therapy.

    Measured: 6 months

Secondary outcomes (4)

  1. Biochemical-Free Survival

    Biochemical-free survival rate at 3 years as defined by Phoenix Criteria.

    Measured: 3 years

  2. Metastasis-Free Survival

    Metastasis-free survival rate at 3 years as defined by RECIST v1.1 criteria.

    Measured: 3 years

  3. Time to Normalization of Serum Testosterone

    Time from normalization is the date of first return to normal serum testosterone 270 ng/ml or greater after withdrawal of androgen deprivation therapy.

    Measured: 3 years

  4. Molecular Alterations in Homologous Recombination Repair Genes

    Molecular alterations in the homologous recombination repair (HHR) genes.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start27 Jul 2023
  3. Primary completion2 Dec 2027 (estimated)
  4. Study completion2 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05568550
Sponsor's protocol ID
MCC-22-GU-80
Status last verified
Jul 2026
First submitted
29 Sep 2022
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Olaparib and Androgen Deprivation Therapy in people with Prostate Cancer, run by Zin W Myint at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bryan Courtney (859-257-3379, bryancourtney@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05568550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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Pembro With Radiation With or Without Olaparib | AzTrials