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

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
41 and older

Gender:
Male

Eligibility

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

Gender: Male
Steward Physician(s)
  • Anthony V D'Amico, M.D. Ph.D.
Trial Interventions
Drug
  • Flutamide (Eulexin) and Lupron or Zoladex
Radiation
  • External Beam Radiotherapy
Physician Researcher

Investigator Name:

  • Anthony V D'Amico, M.D. Ph.D.

Other Information

Sponsor: Dana-Farber Cancer Institute
Phase: Phase 3
Trial ID: NCT00116220
Volunteers:  Not Accepting Healthy Volunteers

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