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A Study of BMS986365 and Degarelix for Prostate Cancer

This study is looking at a new combination treatment for people with localized high-risk prostate cancer. You would receive two drugs, BMS986365 and degarelix, before having standard surgery (radical prostatectomy). BMS986365 is designed to target and break down the androgen receptor (AR), which can help treat prostate cancer. Degarelix works by lowering testosterone production. The main goal is to see if this combination treatment is safe, causes few or mild side effects, and if it can completely clear the cancer before surgery. The study plans to enroll 30 participants and is open to adults aged 18 and older, of all genders. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, complete cancer clearance, will be measured at 42 months.

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NCT07335796

A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~30 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:BMS-986165Degarelix

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of pathologic complete response/pCR
Measured over 42 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

6 sites across 2 states
New York4
New Jersey2

Study leadership

  • Kristine Lacuna, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Kristine Lacuna, MD
[email protected]
646-888-4321
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant or participant's legally authorized representative (LAR) is willing and able to provide written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
Individuals with prostate cancer 18 years of age and above
Histological or cytological evidence of prostate cancer
Documented high-risk localized prostate cancer based on one or more of the following NCCN criteria:
Candidate for RP as determined by treating physician
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Normal organ function with acceptable initial laboratory values within 28 days of registration:

Exclusion

Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan (any PET modality)
On ADT (GnRH agonists or antagonists) for \> 4 weeks at time of consent
Other than ADT as mentioned in 6.2.2, prior systemic therapy for treatment of their prostate cancer, including but not limited to chemotherapy, immunotherapy, etc.
Prior local therapy to the prostate for prostate cancer, including but not limited to radiation, HIFU, phototherapy, etc.
Participants who are considered a poor medical risk due to a serious, uncontrolled medical disorder, or recovering from a recent surgery (approximately within 1 month, or as deemed recent per surgeon), for which in the opinion of the investigator would interfere with treatment on this study.
Any patient who cannot swallow oral medications or have gastrointestinal disorders in the opinion of the investigator are likely to interfere with absorption.
Participant has impaired cardiac function or clinically significant cardiac disease, including any of the following:
Participants with clinically significant venous thromboembolism (eg, pulmonary embolism and deep vein thrombosis) within 3 months prior to the first dose of study intervention.
Active viral hepatitis, including the following:
Known HIV positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/μL. Participants with HIV are eligible if: i. Participant has received ART for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled on study and an HIV viral load less than 400 copies/mL prior to enrollment. ii. Participant continues on ART as clinically indicated while enrolled on study.
Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for basal or squamous cell skin cancer or superficial bladder cancer that has previously been treated.
Use of any prohibited concomitant medications including herbal supplements (Section 10.4) within 2 weeks prior to treatment start
Receiving any other investigational agents within 4 weeks or 5x the half-life of investigational agent (whichever is longer) from this study's treatment start
Known allergy to any of the compounds under investigation
Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

What this trial measures

  • Frequency of pathologic complete response/pCR42 months

    The primary objective is to determine the frequency of achieving a pathologic complete response (pCR) and/or minimal residual disease (MRD defined as ≤ 5 mm tumor) .