drugset / Trial / NCT03849365
Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
Phase 4
Terminated
23 enrolled
Steba Biotech S.A.
International Drug Development Institute · collabPrimeVigilance Ltd., UK · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-01-21
- Primary completion
- 2020-11-13
- Completion
- 2020-11-13
Outcome
Outcome not reported
Stopped: “Early end of enrolment with regards to difficulty met to enrol patients”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TOOKAD | Other / unclassified | 3.66 mg/kg | Intravenous |
Indications
No indication recorded.