Trial | NCT00116220  Report issue

Title

Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    206
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.
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 Started
Sep 30
1995
Primary Completion
Apr 30
2001
Study Completion
Feb 28
2015
Last Update
Jan 06
2022

Drug Flutamide (Eulexin) and Lupron or Zoladex

Androgen suppression therapy

Radiation External Beam Radiotherapy

Once a day, 4-5 days per week for approximately 2 months

Treatment 1 Active Comparator

External beam radiation therapy + 6 months total androgen ablation

Treatment 2 Active Comparator

External beam radiation therapy

Criteria 

Inclusion Criteria:

Biopsy proven prostate cancer
Negative bone scan
Lymph nodes by CT or MRI
Adequate blood work
Performance Status - ECOG 0-1
Life expectancy of at least 10 years
>40 years of age

Exclusion Criteria:

Prior history of malignancy
Prior hormonal therapy or chemotherapy
Prior pelvic radiation therapy
Unable to tolerate lying still 5-10 minutes/day
No Results Posted