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High Risk Prostate CarcinomaPhase 2NCT06528210

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

A Phase 2 study testing Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide and Biopsy Procedure in people with High Risk Prostate Carcinoma and Localized Prostate Adenocarcinoma, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial tests how well pembrolizumab along with standard of care androgen deprivation therapy, with bicalutamide and gonadotropin releasing hormone agonist, and radiotherapy for the treatment of patients with high risk prostate cancer that has not spread to other parts of the body (localized). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide and Biopsy Procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
16 Apr 2025to 1 Jun 2028
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed histologically confirmed non-metastatic adenocarcinoma of the prostate (regional spread as defined by National Comprehensive Cancer Network [NCCN] guidelines is allowed) will be enrolled in this study with any one of the following three high risk features:
  • Gleason grade > 8-10
  • PSA > 20 ng/ml
  • Clinical stage T3a or T3b (T4 not allowed, see exclusion criteria)
  • Participants must agree to use a contraception as detailed in the protocol during the treatment period and for at least 12 months plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
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  • Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 30 days prior to the first dose of study intervention
  • Absolute neutrophil count (ANC) ≥ 1500/µL. (Specimens must be collected within 10 days prior to the start of study intervention)
  • Platelets ≥ 100 000/µL. (Specimens must be collected within 10 days prior to the start of study intervention)
  • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. (Specimens must be collected within 10 days prior to the start of study intervention)
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
  • Creatinine OR measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥ 30 mL/min for participant with creatinine levels > 1.5 × institutional upper limit of normal (ULN). (Specimens must be collected within 10 days prior to the start of study intervention)
  • Creatinine clearance (CrCl) should be calculated per institutional standard
  • Total bilirubin ≤ 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels > 1.5 × ULN. (Specimens must be collected within 10 days prior to the start of study intervention)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases). (Specimens must be collected within 10 days prior to the start of study intervention)
  • International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. (Specimens must be collected within 10 days prior to the start of study intervention)
  • Be willing to undergo a post-treatment prostate biopsy 6 months after completion of therapy on cycle 1 day 1 and optional re-biopsy at 12 months post cycle 1 day 1 if 6-month biopsy was positive for viable tumor
  • PSA ≤ 100 ng/mL within 90 days of initiation of therapy. If PSA is repeated and drops below 100 ng/mL without treatment, enrollment will be permitted
  • If PSMA PET CT scan shows metastatic spread which is not detected on conventional imaging (CT or bone scan), enrollment is allowed if tumor is considered low volume (≤ 4 sites) with no visceral disease. (PSMA PET CT recommended but not required for enrollment.)
  • Must be willing to complete psychosocial and quality of life forms
  • Criteria for known hepatitis B and C positive subjects.
  • Hepatitis B and C screening tests are not required unless:
  • Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • As mandated by local health authority
  • Hepatitis B positive subjects
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
  • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
  • Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
  • Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization

Who cannot join

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
  • Has received prior radiotherapy or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease, with a 1-week washout, is permitted
  • Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
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  • Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder that have undergone potentially curative therapy are not excluded
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
  • Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and hepatitis C virus (defined as anti-HCV antibody [Ab] positive and detectable HCV ribonucleic acid [RNA]) infection.
  • Note: Hepatitis B and C screening tests are not required unless:
  • Known history of HBV and HCV infection
  • As mandated by local health authority
  • Plans to use abiraterone and prednisone in combination with radiotherapy. This must be decided before enrollment
  • Clinical T4 disease is excluded as the primary endpoint cannot be adequately assessed for response in the surrounding tissue based on biopsy
  • Evidence of metastatic, non-regional disease on conventional imaging, including MRI, CT and bone scan
  • Prostate size > 80 cc by MRI or ultrasound
  • Subject has undergone a prior radical prostatectomy. Transurethral resection or other surgical procedure for outlet obstruction allowed
  • Subject has had major surgical procedures within 30 days of allocation
  • Has not adequately recovered from major surgery or has ongoing surgical complications
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Expecting to procreate within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has had an allogenic tissue/solid organ transplant

About this study

Official title: Single-Arm, Open-Label, Phase II Study of Pembrolizumab Plus Androgen Deprivation Therapy (ADT) in Combination With Radiotherapy (RT) for High Risk Localized Prostate Cancer

This phase II trial tests how well pembrolizumab along with standard of care androgen deprivation therapy, with bicalutamide and gonadotropin releasing hormone agonist, and radiotherapy for the treatment of patients with high risk prostate cancer that has not spread to other parts of the body (localized). A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Bicalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Gonadotropin-releasing hormone agonists prevent the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate cancer cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with androgen deprivation therapy and radiotherapy may kill more tumor cells in patients with high risk localized prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the rate of prostate biopsy positivity at 6 months (mo.) in patients receiving pembrolizumab plus androgen deprivation therapy (ADT) in combination with radiotherapy.

II. Determine the safety of pembrolizumab in combination with ADT and radiotherapy.

SECONDARY OBJECTIVES:

  1. Compare 6-month post-treatment biopsy positive rate in patients stratified by pre-treatment prostate infiltrating T-cell PD-1 and PD-L1 expression.

II. Measures changes in health related quality of life (HRQOL). III. Determine the rate of grade 3 or higher Immune-related adverse events (irAEs).

IV. Determine the rate of biochemical relapse-free survival (bRFS) stratified by tumor PD-1 and PD-L1 expression.

EXPLORATORY OBJECTIVES:

  1. Determine the time to cancer-directed treatment in subjects undergoing experimental treatment.

II. Determine the 5-year rate of biochemical relapse-free survival ([bRFS,] i.e. prostate specific antigen [PSA] > nadir + 2 ng/mL) III. Determine the nadir biochemical response rate (nadir PSA ≤ 0.5 ng/mL) IV. Determine the clinical and bRFS at five years. V. Report safety and tolerability of pembrolizumab, defined as pembrolizumab related adverse event of any grade and drug dose modification.

VI. Determine metastases-free survival based on conventional imaging (not positron emission tomography [PET] based).

VII. Determine the serum castration recovery rate (testosterone above 50 ng/dL) VIII. Determine the serum testosterone recovery rate (testosterone above 200 ng/dL) IX. Assess the effect of pembrolizumab combined with ADT + radiation therapy (RT) on serum, blood and tissue markers of the immune response.

  1. Correlate changes in markers of inflammatory response with clinical outcomes including post-treatment biopsy rate, PSA response and tumor free survival.

XI. Correlate baseline prostate specific membrane antigen (PSMA) scan findings with efficacy endpoints.

XII. Changes from pre- to post-treatment serum, peripheral blood mononuclear cells (PBMC), blood, microbial and tissue markers of the immune response.

XIII. Correlation of changes in markers of inflammatory response with clinical outcomes including biopsy-complete response, PSA response and disease free survival.

XIV. Determine the rate of local tumor eradication at 12 months for those who had persistent tumor at 6 months.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for 51 weeks in the absence of disease progression or unacceptable toxicity. Patients receive standard of care ADT with GNRH agonist (leuprolide, goserelin, triptorelin) or GNRH antagonist (relugolix, degarelix) given orally (PO), subcutaneously (sub-Q) or via sub-Q implant for a total of 24 months, bicalutamide PO once per day (QD) for 6 months or up to 24 months per the discretion of the treating physician and radiation therapy per standard of care. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan and/or computed tomography (CT) scan/ magnetic resonance imaging (MRI) during screening and prostate biopsy and blood sample collection throughout the study.

After completion of study therapy, patients are followed up at 30 days and yearly thereafter.

Being tested
Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide, Biopsy Procedure, Biospecimen Collection, Computed Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Gonadotropin Releasing Hormone Agonists and AntagonistsDrug

    Also called GnRH Antagonist, Gonadotropin Releasing Hormone Inhibitor, Leuprolide, Goserelin

    Given PO, IM, Sub-Q injection or Sub-Q implant

  • BicalutamideDrug

    Also called Casodex, Cosudex, ICI 176,334, ICI 176334

    Given PO

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo prostate biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, Keytruda, Lambrolizumab, MK-3475

    Given IV

  • Questionnaire AdministrationOther

    Ancillary study

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

Study groups in NCT06528210
Study groupRoleWhat they receive
Treatment (Pembrolizumab, ADT, radiotherapy)ExperimentalPatients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for 51 weeks in the absence of disease progression or unacceptable toxicity. Patients receive standard of care ADT with GNRH agonist (leuprolide, goserelin, triptorelin) or GNRH antagonist (relugolix, degarelix) for a total of 24 months, bicalutamide PO QD for 6 months or up to 24 months per the discretion of the treating physician and radiation therapy per standard of care. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan and/or CT scan/MRI during screening and prostate biopsy and blood sample collection throughout the study.
Receives: Drug: Gonadotropin Releasing Hormone Agonists and Antagonists; Drug: Bicalutamide; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Bone Scan

What is being measured

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

  1. Biopsy-complete response determined by post-treatment biopsy

    Will be defined as absence of detectable malignant cells in cores evaluated by established histologic techniques. An exact one-sided confidence interval will also be estimated and provided.

    Measured: From first dose of pembrolizumab Cycle 1 Day 1 to 6 months after Cycle 1 Day 1. Cycle length is 21 days.

  2. Incidence of adverse events

    Using Common terminology Criteria for Adverse Events (CTCAE) version 5.

    Measured: From first dose of pembrolizumab to 30 days after last dose of pembrolizumab

Secondary outcomes (4)

  1. Post-treatment cancer detection rates in tumors by levels of PD-1 and PD-L1 expression

    Will be evaluated by pre-treatment prostate infiltrating T-cell PD-1 expression status based on the median split of the expression level. Exact 95% confidence intervals will also be estimated and provided.

    Measured: From first dose of pembrolizumab to 6 months after Cycle 1 Day 1. Cycle length is 21 days.

  2. Health related quality of life

    Will be summarized at each appropriate time point using number completed, mean, standard deviation, and 95% confidence intervals.

    Measured: From screening up to 5 years

  3. Incidence of grade 3 or higher immune related adverse events

    Using CTCAE version 5.

    Measured: From first dose of pembrolizumab to 30 days after last dose of pembrolizumab

  4. Rate of biochemical relapse-free survival

    Will be estimated using Kaplan-Meier method.

    Measured: From enrollment of trial to 30 days post last dose of pembrolizumab

Timeline

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

  1. First posted30 Jul 2024
  2. Study start16 Apr 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Why it stopped: Loss of funding

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06528210
Sponsor's protocol ID
STUDY00025491
Other IDs
NCI-2024-04337, STUDY00025491
Status last verified
Sep 2025
First submitted
30 May 2024
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide and Biopsy Procedure in people with High Risk Prostate Carcinoma and Localized Prostate Adenocarcinoma, run by OHSU Knight Cancer Institute.

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 30 inclusion and 28 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: withdrawn, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy-complete response determined by post-treatment biopsy (time frame: From first dose of pembrolizumab Cycle 1 Day 1 to 6 months after Cycle 1 Day 1. Cycle length is 21 days.). The study lists 2 primary outcomes in all. 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 NCT06528210.

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 23 Sep 2025.

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