Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Gleason 7-10, Immunotherapy, Neoadjuvant Read More

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.