Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
Status:
Terminated
Trial end date:
2020-11-13
Target enrollment:
Participant gender:
Summary
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial
in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the
European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics
of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile
dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.
Phase:
Phase 4
Details
Lead Sponsor:
Steba Biotech S.A.
Collaborators:
International Drug Development Institute PrimeVigilance LTD