Is NCT07335796 recruiting in Rockville Centre, NY?

Yes, NCT07335796 is currently recruiting participants at its Rockville Centre, NY location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Rockville Centre?

To join this clinical trial in Rockville Centre, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rockville Centre clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Rockville Centre, NY

About This Prostate Cancer Study in Rockville Centre

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion 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 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:

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 institutional normal range Magnesium\

within institutional normal range Total Bilirubin ≤ 1.5 x ULN (Note: In participants with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 2.5 x ULN SGPT (ALT) ≤ 2.5 x ULN CrCl\*\

\> 60 mL/min \*If these electrolytes are corrected with supplements, eligibility should be confirmed prior to the first dose of study intervention. \*\*Using Cockcroft-Gault equation or measured CrCl using 24-hour urine collection \- Male Participants: i) A participant who is sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for method(s) of contraception as described below and included in the informed consent form. Note: Azoospermic males are not exempt from contraceptive requirements and will be required to always use a latex or other synthetic condom during any sexual activity (e.g., vaginal, anal, oral) with IOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant. ii) Participants will be required to always use a latex or other synthetic condom during any sexual activity (e.g., vaginal, anal, oral) with IOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention. iii) IOCBP partners of participants should be advised to use a highly effective method of contraception during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention for the male participant. iv) Participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention. v) Participants must refrain from donating sperm during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention. vi) Breastfeeding partners of participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms. See Appendix B for further guidelines and definitions.

Exclusion Criteria

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 prostatectomy per standard-of-care/institutional guidelines.

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: i. LVEF \< 50% as determined by ECHO or MUGA scan at Screening. ii. Complete left bundle branch, high-grade AV block (eg, bifascicular block, Mobitz type II and third-degree AV block), or other clinically significant abnormal ECG finding at Screening. Participant with a permanent pacemaker are excluded. iii. History of clinically significant sinus bradycardia or sick sinus syndrome or bradycardia with heart rate \< 50 bpm at Screening. (Note: All is determined by the average of the triplicate Screening ECG, based on local reading.)

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 tachycardia, ventricular fibrillation, TdP, or resuscitated cardiac arrest, individual or family history of long QT syndrome, or cardiomyopathy. v. Concurrent treatment with antiarrhythmic or other drugs that prolong the QT interval. For study eligibility, a washout period of ≥ 5 half-lives must have elapsed prior to the first dose of study intervention. vi. Congestive heart failure (New York Heart Association Class III or IV) ≤ 12 months prior to the first dose of study intervention. vii. Myocardial infarction, myocarditis, or pericarditis ≤ 6 months prior to the first dose of study intervention. viii. Unstable or poorly controlled angina pectoris (including the Prinzmetal variant of angina pectoris) or symptomatic peripheral vascular disease. ix. Poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Participants with a history of hypertension can be enrolled if the investigator considers that BP is controlled by antihypertensive treatment.

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 vaccination are eligible to enroll. ii. Any positive test result for HCV indicating presence of active viral replication (detectable HCV-RNA). iii. Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.

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. iii. In the case ART is at risk of drug-drug interaction, participants should be switched to an alternate effective ART regimen (with minimal drug-drug interaction potential) before study participation or should be excluded from the study if their regimen cannot be altered. iv. CD4 counts and viral load are monitored per standard of care by a local health care provider.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rockville Centre?

Yes, this clinical trial (NCT07335796) has an active research site in Rockville Centre, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in Rockville Centre, NY

If you're searching for prostate cancer treatment options in Rockville Centre, NY, this clinical trial (NCT07335796) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rockville Centre research site is actively enrolling participants for this clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Rockville Centre, NY

Expert Care in Rockville Centre

IRB Approved

No-Cost Care

Apply for This Rockville Centre Location

Why Participate?

Simple Process