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

2019-07-15 10:04:58 | BioPortfolio

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

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

Study Design

Conditions

Cancer of the Prostate

Intervention

no intervention (post study follow up)

Location

Department of Urology-Tampere University Hospital-
Tampere
Finland
33521

Status

Active, not recruiting

Source

Steba Biotech S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-15T10:04:58-0400

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