Poly ICLC in Treating Patients with Prostate Cancer before Radical Prostatectomy

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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 14 days prior to being registered for protocol therapy
• Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis)
• Gleason 7 – 10, cT2a – cT3b adenocarcinoma of the prostate with plans for radical prostatectomy
• PSA >= 4 ng/ml
• Tumor visible on multiparametric MRI
• 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 intra-tumoral (IT) injection of the poly-ICLC into the prostatic tumor as per the protocol
• No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.); patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least 6 weeks prior to enrollment; patients who have received prior luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is > 50 mg/dl
• 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 patients 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
• Patients with history of human immunodeficiency virus (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
• 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