NCT04017325

European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 374 (actual)
• Sponsor: Steba Biotech S.A. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

Detailed description

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied. All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study. This extension study consists of 2 different follow-up: * a follow-up of patients via investigators * and a follow-up via interviews directly with patients

Conditions

• Cancer of the Prostate

Interventions

Type	Name	Description
OTHER	no intervention (post study follow up)	No intervention (post study follow up)

Timeline

• Start date: 2016-03-17
• Primary completion: 2020-06-03
• Completion: 2020-06-03
• First posted: 2019-07-12
• Last updated: 2021-03-22

Locations

36 sites across 8 countries: Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom