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NCT00167648 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00167648 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 17 participants.
The verdict
NCT00167648, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than 220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000 will die of this disease. Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune system and may be a more effective and long lasting means of inducing immunity to prostate tissue. This study will treat clinically localized prostate cancer patients with either estrogens, or standard androgen deprivation without estrogens, prior to prostatectomy in order more completely to describe immune regulation by estradiol in men. Control tissue from patients who have not been treated with androgen deprivation will be procured from the Northwest Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue samples and blood samples will be assessed for immune system changes.
Interventions
- DRUG Transdermal estradiol
- DRUG Leuprolide or goserelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00167648
The ClinicalTrials.gov registry entry for NCT00167648 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transdermal estradiol is the first listed.
NCT00167648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00167648 about?
NCT00167648 is a clinical study titled "Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer". Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than 220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000 will die of this disease. Androgen deprivation, the elimination of testosterone and its active metabolites, remains th...
What is the current status of trial NCT00167648?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2005-03. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00167648?
The interventions under investigation include: Transdermal estradiol (DRUG), Leuprolide or goserelin (DRUG).
Who is sponsoring clinical trial NCT00167648?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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