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NCT00482807 · ClinicalTrials.gov registry record · Phase 1
Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00482807: Completed Phase 1 study, sponsored by University of Nebraska.
NCT00482807 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00482807, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
Primary Outcome
Toxicity rate as assessed by NCI CTCAE v3.0
Interventions
- DRUG docetaxel
- DRUG goserelin
- RADIATION intensity-modulated radiation therapy
- DRUG bicalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-08-31 |
| Est. Completion | 2010-03-09 |
| Phase | Phase 1 |
What the finished NCT00482807 record still lists
NCT00482807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which docetaxel is the first listed.
NCT00482807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00482807 about?
NCT00482807 is a clinical study titled "Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer". RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cell...
What is the current status of trial NCT00482807?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2004-08-31. Estimated completion is 2010-03-09.
What interventions are being tested in trial NCT00482807?
The interventions under investigation include: docetaxel (DRUG), goserelin (DRUG), intensity-modulated radiation therapy (RADIATION), bicalutamide (DRUG).
Who is sponsoring clinical trial NCT00482807?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00482807's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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