Current partner codePEPTIDESDE
NCT07027124·Phase 2·INTERVENTIONAL

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Status

Recruiting

Phase

Phase 2

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP). Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage \>=cT3a, or PSA l \>20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study: 1. Decipher Genomic classifier, GC\>0.6 2. AR activity score/AR-output gene signature (ARoS)\>11.0 3. High Luminal B score/ PAM50 subtype signature

Full detailed description

The objectives of this study are to evaluate if the neoadjuvant ADT, Darolutamide and Pembrolizumab treatment in high-risk prostate cancer patients stratified based on their genomic characteristics will lead to minimum residual disease (MRD). A total of 40 men ≥ 18 years of age with non-metastatic adenocarcinoma of the prostate, having NCCN high risk localized disease, risk stratified at biopsy based on Decipher score, AR activity score and Luminal B score will be enrolled.

Interventions

Treatment arms and agents.

DRUG

Darolutamide

Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg for 16 weeks prior to RP.

DRUG

Pembrolizumab

Administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 5 cycles prior to RP (Neoadjuvant phase, study weeks 1, 4, 7, 10, 13 \& 16), and every 3 weeks, for a total of 12 cycles post-RP (Adjuvant phase, study weeks, 19, 22, 25, 28, 31, 34, 37, 40 43, 46, 49, \& 52). Total Pembrolizumab cycles=17

DRUG

Lupron

Androgen deprivation, GnRH agonist Leuprolide will be administered at a dose of 22.5 mg SQ (Eligard)/IM Lupron every 12 weeks prior to RP (Study weeks, 1 and 13).

Timeline

From registration to results.

  1. First posted

    Jun 18, 2025

  2. Study start

    May 21, 2026

  3. Primary completion

    Dec 1, 2027

  4. Study completion

    May 2, 2031

  5. Results posted

    Not reported

  6. Registry updated

    Jun 16, 2026

Outcomes

What the study measures.

Primary outcomes

Proportion of patients who achieve Minimal residual disease (MRD)

Time frame · at time of surgery (At Week 17)

MRD is defined as residual cancer burden (RCB) ≤0.25cm³ at final pathology, where RCB is calculated by multiplying the residual tumor volume with the tumor cellularity. The proportion of patients who achieve MRD will be collected at the time of surgery.

Secondary outcomes

Complete pathological response (pCR)

Time frame · After Week 17

Complete pathological response (pCR) is defined as the absence of viable tumor in post treatment prostatectomy specimens). pCR is typically determined by examining the radical prostatectomy specimen after surgery.

Proportion of patients who had had their tumor downstaged

Time frame · at time of surgery (At Week 17)

Proportion of patients who had had their tumor downstaged due to neoadjuvant Pembrolizumab, Darolutamide and ADT at the time of surgery. Downstaging will be determined using MRI and pathology separately.

Adverse events assessed by NCI CTCAE (v.5.0).

Time frame · Week 1 to Week 16, Week 19 to Week 52

Adverse events assessed by NCI CTCAE (v.5.0). Incidence of AEs will be reported for the first cycle of neoadjuvant therapy, for the entire neoadjuvant treatment phase, and for the adjuvant treatment phase.

Biochemical progression free survival bPES

Time frame · Week 22 and until 5 years after Week 17

bPFS is defined as the time from baseline to first evidence of biochemical progression based on PSA level or death, whichever occurs first.

Metastasis free survival (MFS)

Time frame · Week 17 and until 5 years after Week 17

Metastasis free survival (MFS) defined as time from enrollment to detection of metastasis or death, whichever occurs first.

Tumor Volumes

Time frame · Week 0 to Week 17

Median tumor volumes assessed by MRI at baseline and before surgery (and the corresponding change in median tumor volume from baseline to before surgery).

Immunological responses in blood

Time frame · Week 0 to Week 52

A broad immunophenotyping panel will be used to define various immune subsets and their functional states, in pre-treatment and longitudinally collected whole blood samples. Longitudinally collected serum/plasma samples will be analyzed using Olink multiplex assay platform.

Whole exome-sequencing (WES)

Time frame · Week 0 to Week 17

Transcriptomic and genomic changes in tissues - Whole exome-sequencing (WES) will be performed for characterization of the mutational landscape including neoantigens and differentially expressed genes and gene signatures.

RNA sequencing (RNA-seq)

Time frame · Week 0 to Week 17

Transcriptomic and genomic changes in tissues - RNA sequencing (RNA-seq) will be performed for characterization of the mutational landscape including neoantigens and differentially expressed genes and gene signatures.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * Male Age ≥ 18 years at the time of consent * Subjects must have histopathologically confirmed adenocarcinoma of the prostate * Subjects must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant metastasis or non-regional nodal involvement. * Subjects must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline. 1. Decipher Genomic Classifier \>0.45 (interpreted from decipher report) and/ or 2. Luminal B subtype (interpreted from decipher report). * The patient must have a performance status of 0-1 as determined by criteria set forward by the eastern cooperative oncology group. * Subjects with prior neoadjuvant hormonal therapy are allowed if they meet the following criteria. * have completed all treatments ≥ 12, months ago. * Recovered from all AEs due to previous therapies. * If subject has had a major surgery, he should have recovered from all complications and toxicities prior to enrolling in the study. * Adequate organ and marrow function as defined below: * Hematological * Absolute neutrophil count (ANC) ≥ 1,500/mcL * Platelets ≥ 100,000/mcl * Hemoglobin (Hb) ≥ 9 g/dL Hepatic * total bilirubin ≤ 1.5 mg/dl (except in patients with gilbert syndrome who can have total bilirubin \<3.0 mg/dl) * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN Renal * Creatinine OR Creatinine ≤ 1.5 ULN OR * Calculated creatinine clearance Creatinine clearance ≥ 30 ml/min * Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy. Subject must agree to partner use of an additional contraceptive method when having intercourse with women of childbearing potential (WOCBP). * Ability to understand and the willingness to sign a written informed consent. * Subjects who are HBs Ag positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. * Hepatitis B screening tests are not required unless: * Known history of HBV infection * As mandated by local health authority * Subjects with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Subjects must have completed curative anti-viral therapy at least 4 weeks prior to randomization. * Hepatitis C screening tests are not required unless: * Known history of HCV infection * As mandated by local health authority * Subjects with a known history of Human immunodeficiency virus (HIV) infection are eligible as long as they have an undetectable viral. HIV positive participants must be taking stable ART for ≥ 12 weeks and have an undetectable HIV viral load within 28 days before enrollment. Minor fluctuations up to 200 copies/mL are acceptable. Exclusion Criteria: * Subjects with metastatic disease * Subjects with Gleason score ≤7 (3+4) * Subjects with Biopsy Decipher score ≤0.45. * Subjects have had prior hormonal therapy (please see inclusion criteria for exceptions). * Subjects have had prior radiation therapy or chemotherapy for prostate cancer. * Subjects with active cardiac disease defined as having any of the following within 6 months prior to the start of treatment: * myocardial infarction, * severe/unstable angina pectoris, * congestive heart failure, * hospitalization for any cardiac event * Subject has active GI disorder that will interfere with absorption of study drug Darolutamide Subject has prior treatment with androgen receptor inhibitors, such as apalutamide, Darolutamide, enzalutamide, abiraterone acetate or other investigational CYP17 inhibitor. * Inability to swallow oral medications. * Subject has active infection requiring systemic therapy within 7 days of Week 1. * Subject has received prior therapy with anti-PD1, anti-PDL1, anti-PDL2 or with other checkpoint inhibitors or T-cell costimulatory/inhibitory agents (e.g., CD137, OX-40, CTLA4). * Subject with an active viral Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive or detectable \[qualitative\] Hepatitis b virus \[HBV\] DNA or defined as Hepatitis V virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected), known Human Immunodeficiency virus (HIV) infection with detectable viral load, or chronic liver disease with a need of treatment. * Subject has a known active or known history of TB (Bacillus tuberculosis) or active history of non-infectious pneumonitis. * Subject who are immunodeficient or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of study intervention. Topical or inhaled steroids are permitted in absence of immunodeficiency or autoimmune disease. * Subject have active auto-immune disease that has required systemic therapy (use of disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. However, subjects receiving replacement therapy (e.g., insulin, thyroxine, or physiological corticosteroid replacement therapy for adrenal and pituitary insufficiency) are eligible. * Has history or current evidence of any condition, therapy that might confound results of the study. - Has known psychiatric, epileptic or substance abuse history or disorder that would interfere with participant's ability to cooperate with the requirements of the study. * Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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