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NCT06343077 · ClinicalTrials.gov registry record · Phase 2
Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
A Phase 2 study of Prostate Cancer Patients on Active Surveillance, sponsored by Ashutosh Kumar Tewari.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT06343077: Recruiting Phase 2 study of Prostate Cancer Patients on Active Surveillance, sponsored by Ashutosh Kumar Tewari.
NCT06343077 is a Phase 2 study of Prostate Cancer Patients on Active Surveillance that is actively recruiting participants, run by Ashutosh Kumar Tewari. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06343077, a Phase 2 study of Prostate Cancer Patients on Active Surveillance, is actively recruiting participants, sponsored by Ashutosh Kumar Tewari.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.
Conditions Studied
Interventions
- DRUG Poly-ICLC intramuscular (IM) injection
- DRUG Poly-ICLC, Intertumoral (IT) injection
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai (ISMMS) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2024-01-16 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT06343077 shows while recruiting
NCT06343077 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Prostate Cancer Patients on Active Surveillance appearing as the primary indexed condition, and to 2 interventions - of which Poly-ICLC intramuscular (IM) injection is the first listed.
NCT06343077 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06343077 about?
NCT06343077 is a clinical study titled "Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance". 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.
What is the current status of trial NCT06343077?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2024-01-16. Estimated completion is 2026-12-31.
What conditions does trial NCT06343077 study?
This clinical trial studies the following conditions: Prostate Cancer Patients on Active Surveillance.
What interventions are being tested in trial NCT06343077?
The interventions under investigation include: Poly-ICLC intramuscular (IM) injection (DRUG), Poly-ICLC, Intertumoral (IT) injection (DRUG).
Who is sponsoring clinical trial NCT06343077?
This trial is sponsored by Ashutosh Kumar Tewari, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06343077 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06343077's enrollment target sits among peer trials
114 627th of 2000 higher than 1,371 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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