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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:
ClinicalTrials.gov Identifier:
NCT00116220
First Posted: June 28, 2005
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Anthony V. D'Amico, MD, PhD, 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 ]

Secondary Outcome Measures:
  • Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ]

Enrollment: 226
Study Start Date: September 1995
Estimated Study Completion Date: September 2018
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

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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
First Submitted: June 27, 2005
First Posted: June 28, 2005
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Anthony V. D'Amico, MD, PhD, 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
Goserelin
Flutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists