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NCT00003645 · ClinicalTrials.gov registry record · Phase 3
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT00003645: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00003645 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003645, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
Primary Outcome
To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.
Interventions
- DRUG Leuprolide Acetate
- DRUG Flutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 1999-06-14 |
| Est. Completion | 2017-03-20 |
| Phase | Phase 3 |
Why NCT00003645 stopped before completion
NCT00003645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Leuprolide Acetate is the first listed.
NCT00003645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003645 about?
NCT00003645 is a clinical study titled "Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence". RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further t...
What is the current status of trial NCT00003645?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 1999-06-14. Estimated completion is 2017-03-20.
What interventions are being tested in trial NCT00003645?
The interventions under investigation include: Leuprolide Acetate (DRUG), Flutamide (DRUG).
Who is sponsoring clinical trial NCT00003645?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003645's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 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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