CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 50 enrolled
Drug / intervention
TOOKAD Soluble 4 mg/kgdrug
Likely dose
TOOKAD Soluble 4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03315754
NCT03315754Phase 2Active

Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Intermediate Risk Prostate Cancer.

Steba Biotech S.A.·interventional·Posted Oct 20, 2017·Updated Dec 20, 2024

In Brief

A Phase 2 clinical trial evaluating TOOKAD Soluble 4 mg/kg for Localized Prostate Cancer. Active but no longer recruiting, targeting 50 participants across 1 site.

Detailed Summary

Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia. To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP in men with prostate cancer Gleason score 7(3+4).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2ActiveOverdue
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartOct 2, 2017
Primary CompletionNov 2, 2020
Study CompletionFeb 2, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.7 years ago

Interventions

TOOKAD Soluble 4 mg/kgdrug

Vascular targeted photodynamic therapy using TOOKAD Soluble