New York, NYNCT06343077Now EnrollingIRB Ready

Prostate Cancer Patients on Active Surveillance Clinical Trial in New York, NY

Access cutting-edge prostate cancer patients on active surveillance treatment through this phase 2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Ashutosh Kumar Tewari

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Expert Care in New York

Access prostate cancer patients on active surveillance specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related prostate cancer patients on active surveillance treatment provided free

Apply for This New York Location

Check if you qualify for this prostate cancer patients on active surveillance clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Prostate Cancer Patients on Active Surveillance Study in New York

This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.

Sponsor: Ashutosh Kumar Tewari

Who Can Participate

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age \> 18 years at the time of consent.
ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).
Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).
• ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or stage ≥ T2b)
Estimated life expectancy is ≥ 10 years
Candidate for primary curative therapy (Radical prostatectomy or radiation) if cancer progresses.
Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic
Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)
Willing to undergo the intratumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol
No prior hormonal therapy with exception of with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Subjects should be off the medication ≥ 6 months from screening
No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.
No clinically significant infections as judged by the treating investigator.
No characteristics suggesting a potential higher risk of infection with intraprostatic injections:
Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study.
Urine analysis positive for nitrites and leucocyte esterase. Such subjects could be considered for the study after treatment and resolution of the infection.
Active proctitis
History of prostatic abscess
Taking immunosuppressive medication including systemic corticosteroids
Active hematologic malignancy
No uncontrolled angina, congestive heart failure or MI within 6 months.
Subjects with history of HIV (if CD4+ T cell counts are ≥350 cells/μL on established ART therapy), Hepatitis B (with viral load below limits of quantification) or Hepatitis C (who have completed a curative therapy and have a viral load below the limit of quantification) are eligible for this study.
No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.
Patients with the potential for impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
Adequate end organ function as determined by the following laboratory values:
White blood cell count (WBC) ≥ 2.5 k/mm\^3
Absolute neutrophil count (ANC) ≥ 1.5 k/mm\^3
Hemoglobin (Hgb) ≥ 8.0 g/dL
Platelets ≥ 100 k/mm\^3
Calculated creatinine clearance of \> 60 cc/min using the Cockcroft-Gault formula:
Males: \[(140 - Age in years) × Actual Body Weight in kg\]/\[72 × Serum Creatinine (mg/dL)\]
Bilirubin ≤ 2.0 x ULN
Aspartate aminotransferase (AST) ≤ 2.5 x ULN
Alanine aminotransferase (ALT) ≤ 2.5 x ULN

Exclusion Criteria

Received local or systemic curative therapy for prostate cancer
Subjects with neuroendocrine tumors
ISUP Gleason Grade Group (\>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a
Evidence of locally advanced disease
Subject has evidence of any other malignancy
Allergy to any antibiotics, as IT administration requires prophylactic antibiotics.

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 New York?

Yes, this clinical trial (NCT06343077) has an active research site in New York, 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 Patients on Active Surveillance Treatment Options in New York, NY

If you're searching for prostate cancer patients on active surveillance treatment options in New York, NY, this clinical trial (NCT06343077) 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 New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostate cancer patients on active surveillance 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 patients on active surveillance clinical trials near you to find additional studies recruiting in your area.

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