Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients 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.