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NCT00734851 · ClinicalTrials.gov registry record · Phase 2
Multimodality Phase II Study in Prostate Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00734851: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT00734851 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00734851, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free survival at 2 years as measured by lack of PSA progression and no evidence of disease. We hypothesize that this aggressive initial systemic therapy will improve the long term remission rates for men who are undergoing salvage radiation therapy for PSA recurrence in the absence of metastatic disease.
Primary Outcome
Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by
Interventions
- DRUG Docetaxel
- DRUG Sunitinib
- RADIATION EBXRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
Why NCT00734851 stopped before completion
NCT00734851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00734851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00734851 about?
NCT00734851 is a clinical study titled "Multimodality Phase II Study in Prostate Cancer". This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free su...
What is the current status of trial NCT00734851?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2008-12. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00734851?
The interventions under investigation include: Docetaxel (DRUG), Sunitinib (DRUG), EBXRT (RADIATION).
Who is sponsoring clinical trial NCT00734851?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00734851's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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