Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Saint Anne's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00116220
First received: June 27, 2005
Last updated: April 16, 2014
Last verified: April 2014

June 27, 2005
April 16, 2014
September 1995
April 2001   (final data collection date for primary outcome measure)
To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone. [ Time Frame: Years ] [ Designated as safety issue: No ]
To determine freedom from PSA failure when adding total androgen suppression (TAS) to external beam radiation (RT)
Complete list of historical versions of study NCT00116220 on ClinicalTrials.gov Archive Site
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ] [ Designated as safety issue: No ]
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Active Comparator: Treatment 1
    External beam radiation therapy + 6 months total androgen ablation
    Interventions:
    • Drug: Flutamide (Eulexin) and Lupron or Zoladex
    • Radiation: External Beam Radiotherapy
  • Active Comparator: Treatment 2
    External beam radiation therapy
    Intervention: Radiation: External Beam Radiotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
April 2014
April 2001   (final data collection date for primary outcome measure)

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
Male
41 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116220
95-096
Yes
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Saint Anne's Hospital
  • Beth Israel Deaconess Medical Center
  • Metro West Medical Center
Principal Investigator: Anthony V D'Amico, M.D. Ph.D. Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP