Is NCT07027124 recruiting in New York, NY?

Yes, NCT07027124 is currently recruiting participants at its New York, NY location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in New York, NY

About This Prostate Cancer Study in New York

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

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

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.

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07027124) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in New York, NY

If you're searching for prostate cancer treatment options in New York, NY, this clinical trial (NCT07027124) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in New York, NY

Expert Care in New York

IRB Approved

No-Cost Care

Apply for This New York Location

Why Participate?

Simple Process