drugset / Trial / NCT04225299

Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer

NCT04225299 ↗

Phase 3 Withdrawn Steba Biotech S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria.

Timeline

Start
2020-03-31
Primary completion
2030-03-31
Completion
2030-07-01

Outcome

Outcome not reported

Stopped: “FDA didn't approve the design of the protocol so we didn't start the study”

Drugs

EvaluationDrugModalityDoseRoute
Subject TOOKAD Other / unclassified 4 mg/kg Intravenous

Indications