Poly-ICLC Vaccine for the Treatment of Prostate Cancer in Patients on Active Surveillance

Inclusion Criteria

• Written informed consent and Health Insurance Portability and Accountability Act (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
• Eastern Cooperative Oncology Group (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 2 (Gleason 3+4) and grade 1 (Gleason 3+3, with prostate-specific antigen [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 transrectal ultrasound (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 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 myocardial infarction (MI) within 6 months
• Subjects with history of HIV (if CD4+ T cell counts are ≥ 350 cells/uL on established antiretroviral Therapy [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
• 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
• Bilirubin =< 2.0 x upper limit of normal (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 antibiotics, as IT administration requires prophylactic antibiotics