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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 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.

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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.

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

FieldValue
Enrollment Target 2,028 participants
Start Date 1994-10
Est. Completion 2018-05-14
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00002597

The ClinicalTrials.gov registry entry for NCT00002597 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,028 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 606-participant average among 735 other Prostate Cancer trials with a reported enrollment target (235% higher). The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.