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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Flutamide (Eulexin) and Lupron or Zoladex
* Radiation: External Beam Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment 1<br>External beam radiation therapy + 6 months total androgen ablation | Drug: Flutamide (Eulexin) and Lupron or Zoladex<br>* Androgen suppression therapy<br>Radiation: External Beam Radiotherapy<br>* Once a day, 4-5 days per week for approximately 2 months<br>|
| Active Comparator: Treatment 2<br>External beam radiation therapy | Radiation: External Beam Radiotherapy<br>* Once a day, 4-5 days per week for approximately 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy |  | Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Total Androgen Suppression, endorectal coil MRI, External Beam Radiation Therapy, Prostate Cancer- High Risk, clinically Organ-Confined