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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | 11553 | Rockville Centre | New York |
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