Recruiting
Phase 2

Poly-ICLC

Sponsor:

Ashutosh Kumar Tewari

Code:

NCT06343077

Conditions

Prostate Cancer Patients on Active Surveillance

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Poly-ICLC intramuscular (IM) injection

Poly-ICLC, Intertumoral (IT) injection

Study Details

Brief summary:

This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.

Conditions

Prostate Cancer Patients on Active Surveillance

Study ID

NCT06343077

Start date

Jan 16, 2024

Status verified date

Mar, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal health information.

NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

  • 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).
  • • ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or stage ≥ T2b)
  • Estimated life expectancy is ≥ 10 years
  • Candidate for primary curative therapy (Radical prostatectomy or radiation) if cancer progresses.
  • 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 intratumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol
  • No prior hormonal therapy with exception of with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Subjects should be off the medication ≥ 6 months from screening
  • 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 subjects 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.
  • Subjects 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.
  • Patients with the potential for impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
  • Adequate end organ function as determined by the following laboratory values:

  • 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:
  • 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

Exclusion Criteria:

  • Received local or systemic curative therapy for prostate cancer
  • Subjects with neuroendocrine tumors
  • ISUP Gleason Grade Group (>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a
  • Evidence of locally advanced disease
  • Subject has evidence of any other malignancy
  • Allergy to any antibiotics, as IT administration requires prophylactic antibiotics.

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hiltonol (Poly-ICLC)

Enrolled study subjects will receive paired intramuscular (IM) and intertumoral. (IT) injections of the drug Poly-ICLC (Hiltonol®) as follows: Paired 1.5 mg IM (week 1), 1 mg IT once (week 2), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

no intervention: Control (Standard of Care)

Interventions

Poly-ICLC intramuscular (IM) injection

1.5 mg IM (week 1), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

Poly-ICLC, Intertumoral (IT) injection

1 mg IT once (week 2)

Primary outcome measure

  • Proportion of subjects without Gleason group upgrade after treatment [ Time Frame: at 12 months ]
  • Proportion of subjects without Gleason group upgrade after treatment [ Time Frame: at 36 months ]
  • Proportion of subjects without Gleason group downgrade after treatment [ Time Frame: at 12 months ]
  • Proportion of subjects without Gleason group downgrade after treatment [ Time Frame: at 36 months ]

Central Contacts and Locations

Central contacts

Monali Fatterpekar, PhD

212-241-0751monali.fatterpekar@mountsinai.org

Cristina Pasat-karasik, RN

Cristina.Pasat-karasik@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai (ISMMS)

Recruiting

New York, New York, United States, 10029

Contacts

Monali Fatterpekar, PhD

monali.fatterpekar@mountsinai.org

Sujit S Nair, PhD

212-241-7005sujit.nair@mountsinai.org

Principal Investigator:

Ashutosh K Tewari, MD

More Information

Sponsor

Ashutosh Kumar Tewari

Last update posted

Apr 2, 2024

Last verified

Mar, 2024

Keywords

  • Prostate Cancer
  • Active Surveillance
  • Vaccination
  • Immunotherapy
  • drug POLY-ICLC
  • Gleason Grade 2 (Gleason 3+4)
  • Gleason Grade 1 (Gleason 3+3)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ashutosh Kumar Tewari on 2024-04-02.