Prostate Cancer Clinical Trial
Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer
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.
Full 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.
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
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There is 1 Location for this study
New York New York, 10021, United States
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