This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue
PRIMARY OBJECTIVES: I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer. SECONDARY OBJECTIVES: I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores. II. Assess biochemical control after high-dose SBRT. OUTLINE: Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Undergo SBRT
Ancillary studies
Correlative studies
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Time frame: 1.5 months
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Time frame: 4 months
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Time frame: 8 months
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Time frame: 12 months
Quality of Life as Assessed by EPIC Scores
Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time frame: Baseline and 1.5 months
Quality of Life as Assessed by EPIC Scores
Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
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Time frame: Baseline and 4 months
Quality of Life as Assessed by EPIC Scores
Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time frame: Baseline and 8 months
Quality of Life as Assessed by EPIC Scores
Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Time frame: Baseline and 12 months
Quality of Life as Assessed by Change in AUA Scores
Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time frame: Baseline and 1.5 months
Quality of Life as Assessed by Change in AUA Scores
Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time frame: Baseline and 4 months
Quality of Life as Assessed by Change in AUA Scores
Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time frame: Baseline and 8 months
Quality of Life as Assessed by Change in AUA Scores
Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time frame: Baseline and 12 months
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time frame: Baseline and 1.5 months
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time frame: Baseline and 4 months
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time frame: Baseline and 8 months
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time frame: Baseline and 12 months