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New treatment option for Prostate Cancer
Official title A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer
ClinicalTrials.gov ID: NCT07335796
What this study is testing
What is BMS-986165?
BMS-986165 is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant or participant's legally authorized representative (LAR) is willing and able to provide written informed consent and privacy...
- 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:
- PSA ≥ 20ng/ml or
You likely can't join if
- Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan (any PET modality) Patients with...
- 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...
- 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...
- Any patient who cannot swallow oral medications or have gastrointestinal disorders in the opinion of the investigator are likely to interfere with...
See the full eligibility criteria
- 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...
- 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:
- PSA ≥ 20ng/ml or
- Gleason ≥8 or
- Clinical stage ≥cT3a
- 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: ANC ≥ 1.5 K/mcL Hemoglobin ≥ 9g/dL Platelet count ≥ 100 K/mcL Potassium\ within institutional normal range Calcium\ within...
- Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan (any PET modality) Patients with N1 disease may be eligible for the study if planned for a radical...
- 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...
- 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: i. LVEF \< 50% as determined by ECHO or MUGA scan at Screening. ii. Complete left bundle branch...
- A prolongation of the QT interval on Screening ECG as defined by repeated demonstration of a QTc interval ≥ 450 ms using QTcF.
- Participant would be excluded if the QTcF interval cannot be determined on the Screening ECG (eg, unreadable or not interpretable).
- In the presence of right bundle branch block, if measured QTcF is \> 450 ms at baseline, then the ECG for QTc reading should be verified by a cardiologist to confirm eligibility. iv. A history of sustained ventricular...
- 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: i. Any positive test result for HBV indicating presence of virus, eg, HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States; Rockville Centre, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.