Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06343077

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

Led by Ashutosh Kumar Tewari · Updated on 2024-04-02

114

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

A

Ashutosh Kumar Tewari

Lead Sponsor

O

Oncovir, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and HIPAA authorization
  • Age over 18 years
  • ECOG Performance Status of 0-1 within 14 days prior to registration
  • Histologically confirmed adenocarcinoma of the prostate with available diagnostic tissue
  • ISUP Grade 1 (Gleason 3+3) or Grade 2 (Gleason 3+4), or Grade 1 with PSA610 or stage 65 T2b
  • Estimated life expectancy of at least 10 years
  • Candidate for primary curative therapy if cancer progresses
  • Tolerated previous transrectal ultrasound guided biopsy without complications
  • Willing to undergo intratumoral Poly-ICLC injection
  • No prior hormonal therapy except oral 5-alpha-reductase inhibitors, off medication for at least 6 months
  • No prior radiation therapy to pelvis or prostate
  • No clinically significant infections
  • No recurrent urinary tract infections or prostatitis within 3 months prior to enrollment
  • Negative urine analysis for nitrites and leucocyte esterase or treated infection
  • No active proctitis or history of prostatic abscess
  • Not taking immunosuppressive medication including systemic corticosteroids
  • No active hematologic malignancy
  • No uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months
  • HIV patients eligible if CD4+ T cell count 65350 cells/bcL on ART
  • Hepatitis B or C patients eligible if viral load below detection or cured
  • No investigational agent treatment within 28 days prior to protocol therapy
  • Agree to use acceptable birth control to avoid conception during and 2 months after treatment
  • Adequate organ function as defined by blood counts, creatinine clearance, bilirubin, AST, ALT limits
Not Eligible

You will not qualify if you...

  • Prior local or systemic curative therapy for prostate cancer
  • Neuroendocrine tumors
  • ISUP Gleason Grade Group greater than 3, or Gleason 3+3 with PSA 610 or stage 6 T2a
  • Evidence of locally advanced disease
  • Evidence of any other malignancy
  • Allergy to antibiotics needed for prophylactic treatment during IT injection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States, 10029

Actively Recruiting

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Research Team

M

Monali Fatterpekar, PhD

CONTACT

C

Cristina Pasat-karasik, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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