Poly ICLC in Treating Patients with Prostate Cancer before Radical Prostatectomy

Status: Active


This pilot phase I trial studies the best dose and best schedule of poly ICLC in treating patients with prostate cancer before radical prostatectomy. Poly ICLC may help the immune system identify prostate cancer as a foreign invader and attack it and help the body fight against cancer.

Eligibility Criteria

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
  • No known history of human immunodeficiency virus (HIV) (HIV-1/2 antibodies), active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • 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

Locations & Contacts

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Contact: Ashutosh K. Tewari
Phone: 212-241-8971
Email: Ash.tewari@mountsinai.org

Trial Objectives and Outline


I. To define a safe dose and schedule of preoperative intratumoral (IT) plus intramuscular (IM) polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol) prior to radical prostatectomy for patients with intermediate and high-risk prostate cancer (PCa) undergoing radical prostatectomy (RP).


I. To determine the adverse events associated with IT/IM poly-ICLC.

II. To determine the pathological stage, volume and grade of the prostate cancer at the time of prostatectomy in patients treated with IT/IM poly-ICLC.

III. To define the positive surgical margin (PSM) rates.

IV. To determine the radiographic response to IT/IM poly-ICLC as defined by change in size as assessed by dimensions measured on pre-operative multi-parametric magnetic resonance imaging (MRI) and post-operative histopathology.

V. To determine the time to prostate-specific antigen (PSA) progression.


I. To determine whether IT/IM poly-ICLC will induce an innate and/or an adaptive, antitumor immune response within the tumor and/or peripheral blood.

OUTLINE: This is a dose-escalation study.

Patients receive poly ICIC IT once a week during week 1, patients may also receive poly ICIC IT once a week during week 2. Patients then receive booster poly ICIC IM twice weekly during weeks 3-6. During week 10, patients undergo radical prostatectomy per standard of care.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 4 years, and then yearly for up to 10 years.

Trial Phase & Type

Trial Phase

Phase I

Trial Type


Lead Organization

Lead Organization
Icahn School of Medicine at Mount Sinai

Principal Investigator
Ashutosh K. Tewari

Trial IDs

Primary ID 15-2081
Secondary IDs NCI-2018-00103
Clinicaltrials.gov ID NCT03262103