RecruitingPhase 2NCT06343077

Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance


Sponsor

Ashutosh Kumar Tewari

Enrollment

114 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called Poly-ICLC (Hiltonol), an immune-stimulating agent, injected both directly into the prostate tumor and given systemically in men with low-to-intermediate risk prostate cancer who are on active surveillance (watching the cancer closely without immediately treating it). **You may be eligible if...** - You are over 18 years old with confirmed low-grade or early intermediate-grade prostate cancer (Gleason 6 or 3+4) - You are currently on active surveillance and have not started any hormone therapy - Your life expectancy is at least 10 years - You would be a candidate for surgery or radiation if your cancer progresses - You have previously tolerated a prostate biopsy without serious complications **You may NOT be eligible if...** - You have high-grade prostate cancer - You have active autoimmune disease or immune deficiency - You are currently on immunosuppressive medications - You have had major pelvic surgery recently - You are unable to provide consent or comply with the study protocol Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPoly-ICLC intramuscular (IM) injection

1.5 mg IM (week 1), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

DRUGPoly-ICLC, Intertumoral (IT) injection

1 mg IT once (week 2)


Locations(1)

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States

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NCT06343077