ClinicalTrials.Veeva

Menu

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

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Radiation: External Beam Radiotherapy
Drug: Flutamide (Eulexin) and Lupron or Zoladex

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

206 patients

Sex

Male

Ages

41+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

206 participants in 2 patient groups

Treatment 1
Active Comparator group
Description:
External beam radiation therapy + 6 months total androgen ablation
Treatment:
Radiation: External Beam Radiotherapy
Drug: Flutamide (Eulexin) and Lupron or Zoladex
Treatment 2
Active Comparator group
Description:
External beam radiation therapy
Treatment:
Radiation: External Beam Radiotherapy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems