Study on Hiltonol® (Poly-ICLC) Treatment for Prostate Cancer Patients Under Active Surveillance

Sponsor: Ashutosh Kumar Tewari

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06343077

Provider View

This clinical trial is testing whether a drug called Hiltonol® (Poly-ICLC) can help manage prostate cancer in patients who are being closely monitored without active treatment. The study compares patients receiving the drug to those who do not.

Patient Parameters

Program Overview

This study is exploring the effects of a drug called Hiltonol® (Poly-ICLC) in prostate cancer patients who are on active surveillance, meaning they are being monitored closely without immediate treatment. The trial will compare two groups: one receiving the drug and the other receiving standard monitoring. The goal is to see if Hiltonol® can safely and effectively help manage prostate cancer in these patients.

Description

In this study, 114 men with prostate cancer who are on active surveillance will be randomly divided into two groups. One group will receive standard care plus injections of Hiltonol® (Poly-ICLC) directly into the tumor and into the muscle. The other group will receive standard care without the drug.

The treatment group will receive:

  • Preconditioning: Week 1 - Muscle injections of Hiltonol® to prepare the body.
  • Immune Priming: Week 2 - A single injection directly into the tumor.
  • Boosting: Weeks 3 to 10 - Weekly muscle injections.
  • Maintenance: Months 3 to 12 - Monthly muscle injections.

The control group will continue with standard monitoring as per guidelines.

The study will monitor safety and effectiveness by comparing the two groups. An independent board will review the data to ensure safety. The trial is conducted at Mount Sinai Health System and aims to enroll 114 participants. An interim analysis will be done after half of the participants have completed one year of treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share health information.
  • Must be over 18 years old.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must have a confirmed diagnosis of prostate cancer with specific grades and conditions.
  • Must have a life expectancy of at least 10 years.
  • Must be a candidate for surgery or radiation if the cancer progresses.
  • Must have tolerated previous prostate biopsy procedures.
  • Must be willing to receive injections of Hiltonol® into the prostate tumor.
  • Must not have had prior hormonal or radiation therapy for prostate cancer, except for certain medications.
  • Must not have significant infections or conditions that increase infection risk.
  • Must not have uncontrolled heart conditions.
  • Must have controlled HIV, Hepatitis B, or Hepatitis C if applicable.
  • Must not have taken investigational drugs recently.
  • Must agree to use birth control to prevent pregnancy during and after the study.
  • Must have adequate organ function based on specific blood tests.

Exclusion Criteria

  • Have received any treatment aimed at curing prostate cancer.
  • Have neuroendocrine tumors.
  • Have a higher grade of prostate cancer or specific conditions not meeting study criteria.
  • Have evidence of advanced disease.
  • Have any other type of cancer.
  • Have allergies to antibiotics needed for the study.

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