BMS986365 + Degarelix for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Dana Rathkopf, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antiarrhythmics, QT-prolonging drugs

Disqualifiers: Metastatic cancer, Cardiac disease, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out whether BMS986365 in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Who Is on the Research Team?

Kristine Lacuna, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men with high-risk localized prostate cancer who are over 18, have a PSA of ≥20ng/ml, Gleason score ≥8, or stage ≥cT3a. They must be candidates for radical prostatectomy and meet certain blood test requirements. Participants need to agree to use contraception if they're sexually active with partners who can get pregnant.

Inclusion Criteria

My recent tests show my organs are functioning well.

My doctor has approved me for radical prostatectomy.

My prostate cancer diagnosis was confirmed by lab tests.

Exclusion Criteria

I have active viral hepatitis.

I have an active cancer or was diagnosed with another cancer within the last 3 years.

Receiving other investigational agents within specified timeframe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS986365 in combination with degarelix prior to radical prostatectomy

6-8 weeks

Surgical Intervention

Participants undergo standard surgical treatment (radical prostatectomy)

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 months

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986165
• Degarelix

Trial Overview

The trial is testing the safety and effectiveness of BMS986365 combined with degarelix before standard surgery (radical prostatectomy) in treating high-risk localized prostate cancer. The goal is to determine if this combination leads to few or mild side effects.

How Is the Trial Designed?

Group I: Participants with high-risk localized prostate cancer Experimental Treatment 2 Interventions

Eligible participants with high-risk localized prostate cancer based on one or more of the following: PSA \>20ng/ml, Gleason Score ≥8, or Clinical stage ≥cT3a.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+