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NCT00288080 · ClinicalTrials.gov registry record · Phase 3
Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 612
- Enrollment target
NCT00288080: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00288080 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 612 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00288080, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 612 participants
- Enrollment target
Study Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
Primary Outcome
Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Interventions
- DRUG Dexamethasone
- DRUG Prednisone
- RADIATION Radiation therapy
- DRUG docetaxel
- DRUG Oral antiandrogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2005-12 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT00288080 record still lists
NCT00288080 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT00288080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00288080 about?
NCT00288080 is a clinical study titled "Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer". RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Dru...
What is the current status of trial NCT00288080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 612 participants. The study started on 2005-12. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT00288080?
The interventions under investigation include: Dexamethasone (DRUG), Prednisone (DRUG), Radiation therapy (RADIATION), docetaxel (DRUG), Oral antiandrogen (DRUG).
Who is sponsoring clinical trial NCT00288080?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00288080's enrollment target sits among peer trials
612 598th of 2000 higher than 1,401 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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