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NCT00002597 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,028
- Enrollment target
- 20
- Study locations
NCT00002597: Completed Phase 3 study of Prostate Cancer, sponsored by Radiation Therapy Oncology Group.
NCT00002597 is a Phase 3 study of Prostate Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 2,028 participants, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (235% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002597, a Phase 3 study of Prostate Cancer, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,028 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
Primary Outcome
Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Lupron
- RADIATION radiation therapy
- DRUG flutamide
- DRUG Zoladex
Study Locations (20)
California
- Mount Diablo Medical Center - Concord
- Cancer Center and Beckman Research Institute, City of Hope - Duarte
- California Cancer Center - Fresno
- Saint Agnes Cancer Center - Fresno
- Glendale Memorial Hospital and Health Center - Glendale
- Sutter Health Western Division Cancer Research Group - Greenbrae
- University of California San Diego Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Veterans Affairs Medical Center - Long Beach - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- CCOP - Bay Area Tumor Institute - Oakland
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
- Huntsville Hospital System - Huntsville
- Comprehensive Cancer Institute of Huntsville - Huntsville
- MBCCOP - Gulf Coast - Mobile
- Alabama Oncology, LLC - Montgomery
- Radiation Oncology Associates of West Alabama - Tuscaloosa
Alaska
- Providence Alaska Medical Center - Anchorage
Arizona
- Arizona Cancer Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,028 participants |
| Start Date | 1994-10 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 3 |
What the finished NCT00002597 record still lists
NCT00002597 is an interventional study that assigns participants to a tested intervention. Its 2,028 participants enrollment target places it among the larger protocols in the corpus, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (235% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Lupron is the first listed.
NCT00002597 names 20 study sites across 4 states, led by California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT00002597 about?
NCT00002597 is a clinical study titled "Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer". RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regime...
What is the current status of trial NCT00002597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,028 participants. The study started on 1994-10. Estimated completion is 2018-05-14.
What conditions does trial NCT00002597 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00002597?
The interventions under investigation include: Lupron (DRUG), radiation therapy (RADIATION), flutamide (DRUG), Zoladex (DRUG).
Who is sponsoring clinical trial NCT00002597?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002597 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00002597's enrollment target sits among peer trials
2,028 24th of 735 higher than 712 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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