Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.

Detailed Description
-----------------
OBJECTIVES: Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate. Determine the PSA relapse-free survival rate of this patient population. OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks. Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
-----------------
A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate Previously untreated (except for hormonal therapy) PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR PSA levels no greater than 10 ng/mL and Gleason scores at least 7 Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation No evidence of distant metastases No regional lymph node involvement PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No major medical illness No psychosis No metallic pelvic prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Prior neoadjuvant antiandrogen therapy allowed Radiotherapy: No prior radiotherapy No prior pelvic irradiation Surgery: No prior radical surgery for carcinoma of the prostate
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer