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NCT00002874 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
NCT00002874: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00002874 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 840 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002874, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
Primary Outcome
Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Interventions
- DRUG placebo
- RADIATION radiation therapy
- DRUG bicalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 1998-02 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT00002874 record still lists
NCT00002874 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00002874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002874 about?
NCT00002874 is a clinical study titled "Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective wi...
What is the current status of trial NCT00002874?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 1998-02. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT00002874?
The interventions under investigation include: placebo (DRUG), radiation therapy (RADIATION), bicalutamide (DRUG).
Who is sponsoring clinical trial NCT00002874?
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 NCT00002874's enrollment target sits among peer trials
840 392nd of 2000 higher than 1,607 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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