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NCT00007644 · ClinicalTrials.gov registry record · Phase 3
Prostate Cancer Intervention Versus Observation Trial (PIVOT)
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 731
- Enrollment target
NCT00007644: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00007644 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 731 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00007644, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 731 participants
- Enrollment target
Study Summary
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications. The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Primary Outcome
Number of deaths from any cause.
Interventions
- PROCEDURE Radical prostatectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 731 participants |
| Start Date | 1994-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00007644 record still lists
NCT00007644 is an interventional study that assigns participants to a tested intervention. The registered 731 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Radical prostatectomy is the first listed.
NCT00007644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00007644 about?
NCT00007644 is a clinical study titled "Prostate Cancer Intervention Versus Observation Trial (PIVOT)". Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomat...
What is the current status of trial NCT00007644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 731 participants. The study started on 1994-11. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00007644?
The interventions under investigation include: Radical prostatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00007644?
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 NCT00007644's enrollment target sits among peer trials
731 488th of 2000 higher than 1,512 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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