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NCT00524589 · ClinicalTrials.gov registry record · Phase 2
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00524589: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT00524589 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524589, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy . PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- GENETIC protein expression analysis
- OTHER laboratory biomarker analysis
- DRUG dexamethasone
- DIETARY_SUPPLEMENT calcitriol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
Why NCT00524589 stopped before completion
NCT00524589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which protein expression analysis is the first listed.
NCT00524589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524589 about?
NCT00524589 is a clinical study titled "Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy". RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for pros...
What is the current status of trial NCT00524589?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2006-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00524589?
The interventions under investigation include: protein expression analysis (GENETIC), laboratory biomarker analysis (OTHER), dexamethasone (DRUG), calcitriol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00524589?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00524589's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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