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NCT00132301 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
NCT00132301: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00132301 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 298 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00132301, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
Study Summary
VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for patients who are potentially cured by radical prostatectomy but who are at high risk for relapse. The standard of care is surveillance, with the addition of androgen deprivation at the time of biochemical relapse. This study will assess the effect of adding early chemotherapy to the standard of care on progression free survival in Veterans at high risk for progression after prostatectomy.
Primary Outcome
The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.
Interventions
- DRUG Docetaxel
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2006-06 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT00132301 record still lists
NCT00132301 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00132301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00132301 about?
NCT00132301 is a clinical study titled "Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma". VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for patients who are potentially cured by radical prostatectomy but who are at high risk for relapse. The standard of care is surve...
What is the current status of trial NCT00132301?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2006-06. Estimated completion is 2016-09.
What interventions are being tested in trial NCT00132301?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT00132301?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00132301's enrollment target sits among peer trials
298 1162nd of 2000 higher than 838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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