Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03262103

Sponsor: Ashutosh Kumar Tewari

Phase: Phase 1


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age > 18 years at the time of consent. 3. ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual). 4. Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis). 5. Gleason 7
  • 10, cT2a
  • cT3b adenocarcinoma of the prostate with plans for radical prostatectomy 6. PSA ≥ 4 ng/ml 7. Tumor visible on multiparametric MRI 8. Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic a. Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy) 9. Willing to undergo the intra-tumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol 10. 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. 11. No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate. 12. No clinically significant infections as judged by the treating investigator. 13. No characteristics suggesting a potential higher risk of infection with intraprostatic injections: 1. Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study. 2. Urine analysis positive for nitrites and leucocyte esterase. Such patients could be considered for the study after treatment and resolution of the infection. 3. Active proctitis 4. History of prostatic abscess 5. Taking immunosuppressive medication including systemic corticosteroids 6. Active hematologic malignancy 14. No uncontrolled angina, congestive heart failure or MI within 6 months. 15. 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. 16. No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy. 17. 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.

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