RECRUITING

Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance

Quick Facts

Study Start:2024-01-16

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06343077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). * • 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	* 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.

Inclusion Criteria

Exclusion 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).
* • 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

* 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.

Contacts and Locations

Study Contact

Monali Fatterpekar, PhD

CONTACT

212-241-0751

monali.fatterpekar@mountsinai.org

Cristina Pasat-karasik, RN

CONTACT

Cristina.Pasat-karasik@mountsinai.org

Principal Investigator

Sujit S Nair, PhD

STUDY_DIRECTOR

Assistant Professor and Director of GU Immunotherapy Research

Dimple Chakravarty, PhD

STUDY_DIRECTOR

Assistant Professor

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Ashutosh Kumar Tewari

Sujit S Nair, PhD, STUDY_DIRECTOR, Assistant Professor and Director of GU Immunotherapy Research
Dimple Chakravarty, PhD, STUDY_DIRECTOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Prostate Cancer Patients on Active Surveillance