Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
Trial Parameters
Brief 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 Criteria
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 bi