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Hiltonol® for Prostate Cancer on Active Surveillance

This study is testing Hiltonol® (Poly-ICLC) in men with prostate cancer who are on active surveillance (meaning their cancer is being closely watched rather than immediately treated). You could be eligible if you are over 18 and meet certain health criteria. The study aims to see if Hiltonol® can prevent your cancer from getting worse, specifically by preventing a "Gleason group upgrade" (a measure of how aggressive the cancer is) at 12 and 36 months after treatment. The current recruitment status is unclear, but the study plans to enroll 114 participants.

Study design
This is a partially blinded, randomized controlled Phase 2 pilot study. It will compare Hiltonol® treatment to no treatment in 114 participants, with 76 receiving treatment and 38 in a control group.
What's involved
If you are in the treatment group, you would receive Hiltonol® injections into the muscle (intramuscular or IM) and into the tumor (intratumoral or IT) over several weeks and months. The control group will receive standard care.
Compensation
Not stated in the trial record.
Follow-up
The study will track your cancer progression for at least 36 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06343077

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Ashutosh Kumar Tewari
~114 participants
Updated 2024-04-02 on ClinicalTrials.gov
What's tested:Poly-ICLC intramuscular (IM) injectionPoly-ICLC, Intertumoral (IT) injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects without Gleason group upgrade after treatment
Measured over at 12 months
+3 more outcomes measured

Conditions

Prostate Cancer Patients on Active Surveillance

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Sujit S Nair, PhD · STUDY_DIRECTOR · Assistant Professor and Director of GU Immunotherapy Research
  • Dimple Chakravarty, PhD · STUDY_DIRECTOR · Assistant Professor

Who to contact

Monali Fatterpekar, PhD
[email protected]
212-241-0751
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Written informed consent and HIPAA authorization for release of personal health information.
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

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.

What this trial measures

  • Proportion of subjects without Gleason group upgrade after treatmentat 12 months

    Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.

  • Proportion of subjects without Gleason group upgrade after treatmentat 36 months

    Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the three years time point.

  • Proportion of subjects without Gleason group downgrade after treatmentat 12 months

    Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.

  • Proportion of subjects without Gleason group downgrade after treatmentat 36 months

    Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the 3 years time point.