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NCT00583492 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of Suicide Gene Therapy and Prostate Cancer
A Phase 2 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00583492: Completed Phase 2 study, sponsored by Henry Ford Health System.
NCT00583492 is a Phase 2 study that has completed, run by Henry Ford Health System. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583492, a Phase 2 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
Primary Outcome
Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL
Interventions
- RADIATION IMRT
- BIOLOGICAL Ad5-yCD/mutTKSR39rep-ADP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT00583492 record still lists
NCT00583492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which IMRT is the first listed.
NCT00583492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583492 about?
NCT00583492 is a clinical study titled "Randomized Trial of Suicide Gene Therapy and Prostate Cancer". This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagno...
What is the current status of trial NCT00583492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2007-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00583492?
The interventions under investigation include: IMRT (RADIATION), Ad5-yCD/mutTKSR39rep-ADP (BIOLOGICAL).
Who is sponsoring clinical trial NCT00583492?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583492's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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