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Hiltonol (Poly-ICLC) in Prostate Cancer on Active Surveillance
NCT06343077Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), MicroRNA (miRNA)
- Drugs
- poly iclc
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, randomised, single-blind trial of poly iclc in prostate cancer (PCa) (2 arms). Primary endpoints: Proportion of subjects without Gleason group upgrade after treatment at 36 months and Proportion of subjects without Gleason group downgrade after treatment at 36 months. Started Jan 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Hiltonol (Poly-ICLC)
Intratumoral and Intramuscular Poly-ICLC
Control
Standard of Care (Active Surveillance)
03
Who it enrols
Adult males with histologically confirmed adenocarcinoma of the prostate (ISUP Grade 1 or 2) on active surveillance, with no prior curative treatment.
04
Endpoints
Primary
Proportion of subjects without Gleason group upgrade after treatment
Proportion of subjects without Gleason group downgrade after treatment
Secondary
Number of subjects who experience adverse events per NCI-CTCAE 5.0
Number of subjects who receive prostate cancer treatment
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