OncoMatch/Clinical Trials/NCT06343077
Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
Is NCT06343077 recruiting? Yes, currently enrolling (May 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
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)
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
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