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Completed

NCT Number: NCT00116220

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

41 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flutamide (Eulexin) and Lupron or Zoladex

Drug

Androgen suppression therapy

External Beam Radiotherapy

Radiation

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

Primary outcomes

  1. 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 outcomes

  1. Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy

    Time frame: Years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Metro West Medical Center
  • Saint Anne's Hospital

Registry information

Official study title

A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

Important dates

Study start
1995
Primary completion
2001
Study completion
2015
First posted
Jun 28, 2005
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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