drugset
drugset / Trial / NCT03315754

Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.

NCT03315754 ↗

Phase 2 Active not recruiting 50 enrolled Steba Biotech S.A.
NaSingle-groupOpen-labelTreatment

Summary

Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia. To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP in men with prostate cancer Gleason score 7(3+4).

Timeline

Start
2017-10-02
Primary completion
2020-11-02
Completion
2025-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject TOOKAD Soluble Unknown 4 mg/kg Intravenous

Indications

No indication recorded.