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

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.

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 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 Criteria:

- 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.

Conditions:
• Prostatic Neoplasms