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NCT00298155 · ClinicalTrials.gov registry record · Phase 2
Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00298155: Completed Phase 2 study, sponsored by University of Washington.
NCT00298155 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00298155, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 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. This is usually achieved by surgical removal of the testes (orchiectomy), by suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the disease. Most patients progress within 0-5 years, and all patients ultimately progress if the cancer is not eliminated during initial therapy (usually prostatectomy or radiation). Hormone suppression treatment eliminates the detectable levels of testosterone in the blood. However, the testosterone levels in tissue remain high enough to stimulate androgen receptors. Overexpression of androgen receptors is present in all cell lines which demonstrate "androgen independence," i.e., are resistant to androgen-suppressive therapy. Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied by the adrenal glands. The presumption that standard androgen deprivation achieves the optimal level of androgen suppression for patients is based on the levels of androgen which result from orchiectomy. However, because adrenal androgen levels are unaffected by standard modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy. The hypothesis of this study is that more effective suppression of the androgen axis through elimination of adrenal androgens and more effective suppression of testosterone metabolites will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and augmenting natu
Primary Outcome
Tissue dihydrotesterone (DHT)
Interventions
- DRUG goserelin with dutasteride
- DRUG goserelin with bicalutamide and dutasteride
- DRUG goserelin with bicalutamide and dutasteride and ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT00298155 record still lists
NCT00298155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which goserelin with dutasteride is the first listed.
NCT00298155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00298155 about?
NCT00298155 is a clinical study titled "Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer". Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate cancer in the USA this year and more than 30,000 will die of this disease. Androgen deprivation, the el...
What is the current status of trial NCT00298155?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2006-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00298155?
The interventions under investigation include: goserelin with dutasteride (DRUG), goserelin with bicalutamide and dutasteride (DRUG), goserelin with bicalutamide and dutasteride and ketoconazole (DRUG).
Who is sponsoring clinical trial NCT00298155?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00298155's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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