Study on BMS986365 and Degarelix for Prostate Cancer Treatment

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07335796

This clinical trial is exploring whether the combination of BMS986365 and degarelix, given before surgery, is a safe and effective treatment for people with high-risk localized prostate cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if using BMS986365 together with degarelix before surgery can safely and effectively treat people with high-risk localized prostate cancer, while causing few or mild side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent and allow access to personal health information.
  • Men aged 18 and older with prostate cancer.
  • Must have confirmed prostate cancer through lab tests.
  • Must have high-risk localized prostate cancer, defined by:
    • PSA level of 20 ng/ml or higher
    • Gleason score of 8 or higher
    • Clinical stage of cT3a or higher
  • Must be a candidate for surgery as determined by a doctor.
  • Must have a performance status score of 2 or lower, indicating good overall health.
  • Must have normal organ function and acceptable lab test results within 28 days before starting the study.
  • Must agree to use effective contraception during the study and for a specified period after the last dose.
  • Must not donate sperm during the study and for a specified period after the last dose.

Exclusion Criteria

  • Evidence of prostate cancer spread beyond the pelvis.
  • On hormone therapy for more than 4 weeks at the time of consent.
  • Previous systemic therapy for prostate cancer, such as chemotherapy or immunotherapy.
  • Previous local treatments to the prostate, like radiation or phototherapy.
  • Considered a poor medical risk due to serious health issues or recent surgery.
  • Unable to swallow pills or have digestive issues affecting absorption.
  • Heart problems or significant heart disease, including:
    • Low heart function or abnormal heart rhythms
    • History of serious heart conditions
    • Taking medications that affect heart rhythms
  • Recent heart failure or heart attack.
  • Poorly controlled high blood pressure.
  • Recent significant blood clots.
  • Active viral hepatitis or HIV with certain conditions.
  • Other active cancers requiring treatment, except for certain skin or bladder cancers.
  • Use of certain medications or supplements that are not allowed during the study.
  • Participation in another clinical trial or use of investigational drugs recently.
  • Known allergy to study drugs.
  • Any other condition that would prevent participation in the study.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activites)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)11553Rockville CentreNew York

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