Clinical trial
Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone…
NCT00086736 · University of Alabama at Birmingham, Other · Completed
Key facts
| NCT number | NCT00086736 |
|---|---|
| Title | Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy |
| Official title | A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human… |
| Lead sponsor | University of Alabama at Birmingham, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Prostate Cancer |
| Intervention type | Drug |
| Interventions | bicalutamide, eflornithine, oral eflornithine placebo, oral bicalutamide placebo |
| Enrollment | 34 |
| Start date | Nov 1, 2001 |
| Primary completion | Nov 1, 2003 |
| Completion | Nov 1, 2003 |
| First posted | Jul 12, 2004 |
| Last update posted | Nov 19, 2013 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: