Using Hiltonol® to treat prostate cancer patients on active surveillance
Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance
This study is testing if adding Hiltonol® injections to the usual care can help prostate cancer patients who are being closely monitored feel better and stay healthy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06343077 on ClinicalTrials.gov |
What this trial studies
This phase II pilot study evaluates the efficacy and safety of Poly-ICLC (Hiltonol®) in prostate cancer patients who are on active surveillance. A total of 114 participants will be randomly assigned to receive either the standard of care plus Poly-ICLC injections or standard care alone. The treatment group will receive a series of intratumoral and intramuscular injections of Poly-ICLC over a 12-month period, while the control group will continue with standard care as per guidelines. An independent data and safety monitoring board will oversee the study to ensure participant safety and assess treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with histologically confirmed low-grade prostate cancer on active surveillance.
Not a fit: Patients with high-grade prostate cancer or those not eligible for active surveillance may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance immune response and potentially delay or prevent progression of prostate cancer in patients on active surveillance.
How similar studies have performed: Previous studies have shown promise in using immunotherapy approaches for prostate cancer, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai (ISMMS) — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Monali Fatterpekar, PhD
- Email: monali.fatterpekar@mountsinai.org
- Phone: 212-241-0751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.