Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-04 @ 10:24 AM
Study NCT ID:
NCT00116220
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2005-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.
Detailed Description:
This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: