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NCT00223665 · ClinicalTrials.gov registry record · Phase 2
Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT00223665: Completed Phase 2 study, sponsored by University of Washington.
NCT00223665 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223665, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival. They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density.
Primary Outcome
Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL.
Interventions
- DRUG Leuprolide Acetate
- DRUG Flutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 1997-01-08 |
| Est. Completion | 2012-09-06 |
| Phase | Phase 2 |
What the finished NCT00223665 record still lists
NCT00223665 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Leuprolide Acetate is the first listed.
NCT00223665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00223665 about?
NCT00223665 is a clinical study titled "Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer". This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became cas...
What is the current status of trial NCT00223665?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 1997-01-08. Estimated completion is 2012-09-06.
What interventions are being tested in trial NCT00223665?
The interventions under investigation include: Leuprolide Acetate (DRUG), Flutamide (DRUG).
Who is sponsoring clinical trial NCT00223665?
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 NCT00223665's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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