drugset / Trial / NCT04225299
Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TOOKAD | Other / unclassified | 4 mg/kg | Intravenous |