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NCT00086736 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00086736 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 34 participants.
The verdict
NCT00086736, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight prostate cancer by stopping the adrenal glands from producing androgens. Combining eflornithine with bicalutamide may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for localized prostate cancer.
Interventions
- DRUG bicalutamide
- DRUG eflornithine
- DRUG oral eflornithine placebo
- DRUG oral bicalutamide placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2001-11 |
| Est. Completion | 2003-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086736
The ClinicalTrials.gov registry entry for NCT00086736 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which bicalutamide is the first listed.
NCT00086736 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00086736 about?
NCT00086736 is a clinical study titled "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". RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight prostate cancer by stopping t...
What is the current status of trial NCT00086736?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2001-11. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00086736?
The interventions under investigation include: bicalutamide (DRUG), eflornithine (DRUG), oral eflornithine placebo (DRUG), oral bicalutamide placebo (DRUG).
Who is sponsoring clinical trial NCT00086736?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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