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NCT00438464 · ClinicalTrials.gov registry record · Phase 2
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
A Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 204
- Enrollment target
- 8
- Study locations
NCT00438464: Completed Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT00438464 is a Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 204 participants, above the 100-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (104% higher). The trial reports 8 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00438464, a Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 204 participants
- Enrollment target
- 8
- Study locations
Study Summary
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicab
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Finasteride
- PROCEDURE Prostatectomy
- OTHER Laboratory biomarker analysis
Study Locations (8)
Texas
- University of Texas Southwestern Medical Center - Dallas
- M D Anderson Cancer Center - Houston
- Audie L Murphy Veterans Affairs Hospital - San Antonio
- Cancer Therapy and Research Center - San Antonio
- University Hospital - San Antonio
- University of Texas Health Science Center at San Antonio - San Antonio
Ohio
- Cleveland Clinic Foundation - Cleveland
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2007-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT00438464 record still lists
NCT00438464 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (104% higher).
The record links to 2 conditions, with Adenocarcinoma of the Prostate appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00438464 lists 8 locations in 2 states (Texas, Ohio).
Frequently Asked Questions
What is clinical trial NCT00438464 about?
NCT00438464 is a clinical study titled "Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery". This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testoster...
What is the current status of trial NCT00438464?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2007-02. Estimated completion is 2012-04.
What conditions does trial NCT00438464 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Prostate, Stage II Prostate Cancer.
What interventions are being tested in trial NCT00438464?
The interventions under investigation include: Placebo (OTHER), Finasteride (DRUG), Prostatectomy (PROCEDURE), Laboratory biomarker analysis (OTHER).
Who is sponsoring clinical trial NCT00438464?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00438464 being conducted?
This trial has 8 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adenocarcinoma of the Prostate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00438464's enrollment target sits among peer trials
204 3rd of 21 higher than 19 of 21 other Adenocarcinoma of the Prostate trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adenocarcinoma of the Prostate 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.
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