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New treatment option for Prostate Cancer
Official title Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT07027124
What this study is testing
What is Darolutamide?
Darolutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Also referred to as Nubeqa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male Age ≥ 18 years at the time of consent
- people must have histopathologically confirmed adenocarcinoma of the prostate
- people must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant...
- people must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline.
- Decipher Genomic Classifier \>0.45 (interpreted from decipher report) and/ or
You likely can't join if
- people with metastatic disease
- people with Gleason score ≤7 (3+4)
- people with Biopsy Decipher score ≤0.45.
- people have had prior hormonal therapy (please see inclusion criteria for exceptions).
- people have had prior radiation therapy or chemotherapy for prostate cancer.
- people with active cardiac disease defined as having any of the following within 6 months prior to the start of treatment:
See the full eligibility criteria
Who can join
- Male Age ≥ 18 years at the time of consent
- people must have histopathologically confirmed adenocarcinoma of the prostate
- people 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.
- people must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline.
- Decipher Genomic Classifier \>0.45 (interpreted from decipher report) and/ or
- 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.
- people 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...
- Ability to understand and the willingness to sign a written informed consent.
- people 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: people should remain on anti-viral therapy...
- Hepatitis B screening tests are not required unless:
- Known history of HBV infection
- As mandated by local health authority
- people with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: people 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
- people 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...
What rules you out
- people with metastatic disease
- people with Gleason score ≤7 (3+4)
- people with Biopsy Decipher score ≤0.45.
- people have had prior hormonal therapy (please see inclusion criteria for exceptions).
- people have had prior radiation therapy or chemotherapy for prostate cancer.
- people 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...
- 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]...
- 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...
- 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, people receiving replacement...
- 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...
- people 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...
- Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.