This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
PRIMARY OBJECTIVES: I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy. SECONDARY OBJECTIVES: I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires). II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue. III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT. OUTLINE: Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy. After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Time frame: At 4 weeks post surgery
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).
Time frame: Up to 1 year
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.
Time frame: score from baseline to twelve months
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Time frame: Mean change in I-PSS score from baseline to 12 months.
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT
Time frame: Baseline and to up to 1 year
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