This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment. SECONDARY OBJECTIVES: I. Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire. II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years. V. Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse. OUTLINE: Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks. After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Correlative studies
Undergo proton beam radiation therapy
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
Time frame: Up to 2 years post-treatment
Rates of acute toxicity
Rates of acute toxicity will be assessed.
Time frame: Within 90 days of treatment initiation
Rate of late toxicity
Rate of late toxicity will be determined.
Time frame: Up to 5 years post-treatment
Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire
Change in HRQOL will be evaluated.
Time frame: Baseline to up to 5 years
Incidence of rising prostate-specific antigen (PSA)
Incidence of rising PSA will be assessed.
Time frame: At 5 years
Rate of local failure by biopsy
Rate of local failure by biopsy will be evaluated.
Time frame: Up to 5 years
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