Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

Inclusion Criteria

• •Written informed consent and HIPAA authorization for release of personal health information.
• •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).
• •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 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 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 MI within 6 months.
• •Patients 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.
• •* Adequate end organ function as determined by the following laboratory values:
• •* White blood cell count (WBC) \> 2.5 k/mm3
• •* Absolute neutrophil count (ANC) \> 1.5 k/mm3
• •* Hemoglobin (Hgb) \> 8.0 g/dL
• •* Platelets \> 100 k/mm3
• •* 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 18) Able to speak, read and write in English.