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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: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Flutamide (Eulexin) and Lupron or Zoladex
Radiation: External Beam Radiotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 1995
Estimated Study Completion Date: April 2014
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment 1
External beam radiation therapy + 6 months total androgen ablation
 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 2
External beam radiation therapy
 Radiation: External Beam Radiotherapy
Once a day, 4-5 days per week for approximately 2 months

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.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116220

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Saint Anne's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Investigators
Principal Investigator: Anthony V D'Amico, M.D. Ph.D. Dana-Farber Cancer Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00116220     History of Changes
Other Study ID Numbers: 95-096
Study First Received: June 27, 2005
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer
Total Androgen Suppression
endorectal coil MRI
External Beam Radiation Therapy
Prostate Cancer- High Risk, clinically Organ-Confined

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Flutamide
Goserelin
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Androgen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013