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NCT03315754 · ClinicalTrials.gov registry record · Phase 2
Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.
A Phase 2 study of Localized Prostate Cancer, sponsored by Steba Biotech S.A..
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03315754: Active Phase 2 study of Localized Prostate Cancer, sponsored by Steba Biotech S.A..
NCT03315754 is a Phase 2 study of Localized Prostate Cancer that is active but no longer recruiting, run by Steba Biotech S.A.. The registered enrollment target is 50 participants, below the 109-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315754, a Phase 2 study of Localized Prostate Cancer, is active but no longer recruiting, sponsored by Steba Biotech S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Binary response to treatment defined as absence of Gleason grade 4 or 5 on biopsy on 12-month post-treatment following TOOKAD® Soluble VTP in men with Gleason score 7 (3+4) prostate cancer
Conditions Studied
Interventions
- DRUG TOOKAD Soluble 4 mg/kg
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2025-02-02 |
| Phase | Phase 2 |
What the registry record for NCT03315754 still lists
NCT03315754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 109-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Localized Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which TOOKAD Soluble 4 mg/kg is the first listed.
NCT03315754 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03315754 about?
NCT03315754 is a clinical study titled "Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.". 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 o...
What is the current status of trial NCT03315754?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-10-02. Estimated completion is 2025-02-02.
What conditions does trial NCT03315754 study?
This clinical trial studies the following conditions: Localized Prostate Cancer.
What interventions are being tested in trial NCT03315754?
The interventions under investigation include: TOOKAD Soluble 4 mg/kg (DRUG).
Who is sponsoring clinical trial NCT03315754?
This trial is sponsored by Steba Biotech S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315754 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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