Is NCT06347705 recruiting in Montvale, NJ?

Yes, NCT06347705 is currently recruiting participants at its Montvale, NJ location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Montvale?

To join this clinical trial in Montvale, 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 Montvale 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 Montvale, NJ

About This Prostate Cancer Study in Montvale

The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the bo

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately

Male aged 18 years and above

Serum testosterone of ≥150 ng/dL except for patients currently on ADT.

Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by: ANC ≥1500/µl (≥1000/µl if benign ethnic neutropenia) Hemoglobin ≥9 g/dL Platelet count ≥100,000/µl Creatinine Clearance Measure by Cockcroft-Gault Formula \>45 mL/min Total Bilirubin ≤ 1.8 mg/dl (Note: In participants with Gilbert's syndrome, if total bilirubin is 1.8 mg/dL, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 92.5 U/L SGPT (ALT) ≤ 137 U/L

Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI.

Candidate for RP with lymph node dissection as per the investigator

Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.

Evidence of a prostate lesion on prostate magnetic resonance imaging scan

Exclusion Criteria

Participants that meet any of the criteria listed below will not be eligible for study entry:

Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy as a treatment for prostate cancer or benign prostatic disease.

Current ADT with GnRH antagonist/agonist and/or ARSI initiated \>12 weeks enrollment.

Prior cytotoxic chemotherapy for prostate cancer

Prior experimental therapy for prostate cancer within 30 days of planned Cycle 1 of 2141-V11.

Known brain, liver, lung or other visceral metastasis (with the exception of retroperitoneal and / or pelvic nodal metastases as per inclusion criteria)

Prior prostate cancer metastasis-directed therapies other than described above.

Currently active second malignancy or past medical history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of \< 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer.

Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:

Any medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone once daily

Active infection requiring systemic therapy

History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

Uncontrolled hypertension (systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP \<160 mmHg or diastolic BP \<95 mmHg)

Acute or chronic hepatitis B or hepatitis C infection. (Hepatitis B and C testing are not mandatory)

Presence of hepatitis B surface antibody is acceptable

Baseline moderate and severe hepatic impairment (Child Pugh Class B \& C)

Human immunodeficiency virus (HIV)-positive participants with 1 or more of the following:

Not receiving highly active anti-retroviral therapy.

A change in anti-retroviral therapy within 6 months of the start of screening (except if, after consultation with the principal investigator (PI) / sponsor, a change is made to avoid a potential drug-drug interaction with the study drug).

Receiving anti-retroviral therapy that may interfere with the study drug(s) (consult the PI / sponsor for review of medication prior to enrollment).

CD4 count \< 350 cell/mm3 at screening.

An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.

HIV testing is not mandatory

History of pituitary or adrenal dysfunction

Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start.

History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to treatment start; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)

History of an inflammatory bowel disease (Crohn's or ulcerative colitis)

Any additional medications that investigators are concerned will affect the response to immunotherapy.

Use of any prohibited concomitant medications precluding safe treatment with ADT or an ARSI within 14 days prior to treatment start. Note: Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to treatment start

Known allergies, hypersensitivity or intolerance to apalutamide, enzalutamide, daralutamide or GNRH agonist or GNRH antagonist

Participants that cannot tolerate MRI

For cohort B, clinically significant symptoms related to local or metastatic disease.

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 Montvale?

Yes, this clinical trial (NCT06347705) has an active research site in Montvale, NJ 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 Montvale, NJ

If you're searching for prostate cancer treatment options in Montvale, NJ, this clinical trial (NCT06347705) 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 Montvale research site is actively enrolling participants for this phase 2 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 Montvale, NJ

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