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NCT00006371 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00006371: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00006371 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006371, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
Primary Outcome
Determine the PSA response proportion and duration of response of patients with localized stage IV (D0.5) adenocarcinoma of the prostate treated with early medical adrenalectomy using hydrocortisone combined with aminoglutethimide or ketoconazole after prior antiandrogen withdrawal.
Interventions
- DRUG ketoconazole
- DRUG therapeutic hydrocortisone
- DRUG aminoglutethimide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2000-05 |
| Est. Completion | 2001-12 |
| Phase | Phase 2 |
Why NCT00006371 stopped before completion
NCT00006371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which ketoconazole is the first listed.
NCT00006371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006371 about?
NCT00006371 is a clinical study titled "A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer". RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURP...
What is the current status of trial NCT00006371?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2000-05. Estimated completion is 2001-12.
What interventions are being tested in trial NCT00006371?
The interventions under investigation include: ketoconazole (DRUG), therapeutic hydrocortisone (DRUG), aminoglutethimide (DRUG).
Who is sponsoring clinical trial NCT00006371?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006371's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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