OncoMatch/Clinical Trials/NCT06343077
Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
Is NCT06343077 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Poly-ICLC intramuscular (IM) and Poly-ICLC, Intertumoral (IT) for prostate cancer patients on active surveillance.
Treatment: Poly-ICLC intramuscular (IM) · Poly-ICLC, Intertumoral (IT) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage ISUP GRADE 1 (GLEASON 3+3), ISUP GRADE 2 (GLEASON 3+4), ISUP GRADE 1 (GLEASON 3+3, WITH PSA≥10, OR STAGE ≥ T2B) (ISUP/Gleason/T-stage)
Excluded: Stage ISUP GLEASON GRADE GROUP (>3), GLEASON 3+3 PLUS PSA ≤ 10, STAGE ≤T2A, EVIDENCE OF LOCALLY ADVANCED DISEASE
ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or stage ≥ T2b); ISUP Gleason Grade Group (>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a [excluded]; Evidence of locally advanced disease [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: hormonal therapy
Exception: oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.) allowed if off ≥ 6 months from screening
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
Cannot have received: radiation therapy
No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.
Cannot have received: local or systemic curative therapy for prostate cancer
Received local or systemic curative therapy for prostate cancer
Cannot have received: investigational agent
No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.
Lab requirements
Blood counts
WBC ≥ 2.5 k/mm^3; ANC ≥ 1.5 k/mm^3; Hemoglobin ≥ 8.0 g/dL; Platelets ≥ 100 k/mm^3
Kidney function
Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula
Liver function
Bilirubin ≤ 2.0 x ULN; AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN
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; Bilirubin ≤ 2.0 x ULN; Aspartate aminotransferase (AST) ≤ 2.5 x ULN; Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai (ISMMS) · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06343077 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage ISUP GRADE 1 (GLEASON 3+3) or ISUP GRADE 2 (GLEASON 3+4) or ISUP GRADE 1 (GLEASON 3+3, WITH PSA≥10, OR STAGE ≥ T2B) is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages