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NCT00895310 · ClinicalTrials.gov registry record · Phase 2
Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy
A Phase 2 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00895310: Completed Phase 2 study, sponsored by University of California, Davis.
NCT00895310 is a Phase 2 study that has completed, run by University of California, Davis. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00895310, a Phase 2 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of ketoconazole and how well it works after chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections however has not yet been approved by the Food and Drug Administration for use in prostate cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this study will be to look at use of lower dose ketoconazole after someone has received chemotherapy. Ketoconazole works by halting the production of steroids in your body, including testosterone, and is thought to work directly on prostate cancer cells in published lab studies.
Primary Outcome
Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a \>=50% decrease in PSA.
Interventions
- DRUG Hydrocortisone
- DRUG Ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT00895310 record still lists
NCT00895310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydrocortisone is the first listed.
NCT00895310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00895310 about?
NCT00895310 is a clinical study titled "Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy". The purpose of this study is to test the safety of ketoconazole and how well it works after chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections however has not yet been approved by the Food and Drug Administration for use in prostate cancer. Ketoconazole has b...
What is the current status of trial NCT00895310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00895310?
The interventions under investigation include: Hydrocortisone (DRUG), Ketoconazole (DRUG).
Who is sponsoring clinical trial NCT00895310?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895310's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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