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NCT00134056 · ClinicalTrials.gov registry record · Phase 3
S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,038
- Enrollment target
NCT00134056: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00134056 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 1,038 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00134056, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,038 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
Primary Outcome
Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.
Interventions
- DRUG prednisone
- OTHER placebo
- DRUG docetaxel
- DRUG atrasentan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,038 participants |
| Start Date | 2006-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT00134056 record still lists
NCT00134056 is an interventional study that assigns participants to a tested intervention. Its 1,038 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 4 interventions - of which prednisone is the first listed.
NCT00134056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00134056 about?
NCT00134056 is a clinical study titled "S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy". RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet ...
What is the current status of trial NCT00134056?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,038 participants. The study started on 2006-08. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00134056?
The interventions under investigation include: prednisone (DRUG), placebo (OTHER), docetaxel (DRUG), atrasentan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00134056?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00134056's enrollment target sits among peer trials
1,038 287th of 2000 higher than 1,714 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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