This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.
PRIMARY OBJECTIVES: I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy. II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by disease free survival (DFS). SECONDARY OBJECTIVES: I. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26. II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases. III. To determine the correspondence between the diagnostic magnetic resonance imaging (MRI) and biopsy. IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2.1 = 4/5 disease is prognostic for biochemical failure. EXPLORATORY OBJECTIVES: I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective than standard hypofractionated IMRT as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). II. To determine if disease characteristics captured on baseline and follow-up MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT. III. To validate autosegmentation tools for the prostate and tumors. IV. Collect specimens for future translational research analyses. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days. ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
692
Undergo IMRT
Ancillary studies
Ancillary studies
Undergo SBRT
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, United States
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States
Incidence of patients-reported gastrointestinal and genitourinary toxicity
Will be measured by Expanded Prostate Cancer Index Composite-(EPIC) 26 bowel and urinary irritation domains. Will be compared between treatment arms using a test of proportions with two-sided significance level of 0.05.
Time frame: Up to 2 years
Disease free survival
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Time frame: Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years
Health related quality of life
Will be measured by EPIC-26 urinary incontinence, sexual, and hormonal domains.
Time frame: Up to 2 years
Biochemical failure
Will be assessed by Phoenix definition.
Time frame: Up to 2 years
Local failure
Time frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years
Regional failure
Time frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years
Distant metastasis
Time frame: From the time of randomization to the date of distant metastasis, date of precluding death, or last known follow-up date, assessed for up to 2 years
Prostate cancer specific survival
Time frame: Up to 2 years
Overall survival
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Time frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 5 years
Incidence of adverse events (AEs)
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher genitourinary (GU) and gastrointestinal (GI) events related to treatment (separately) will also be tested. There are 5 pre-specified AEs, dysuria, hematuria, incontinence, rectal bleeding, and fatigue. A comparison of any event and grade and higher events will be compared between treatment arms. All comparisons will be tested using a Chi-Square test with a significance level of 0.05.
Time frame: Up to 2 years
Presence of Prostate Imaging-Reporting and Data System version (PIRADSv) 2 = 4/5 disease
Will be assessed by magnetic resonance imaging (MRI).
Time frame: Baseline
Predictive value of PIRADSv2 = 4/5 disease for biochemical failure
Predictive value of PIRADSv2 = 4/5 disease for biochemical failure
Time frame: Up to 2 years
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Arizona Center for Cancer Care-Surprise
Surprise, Arizona, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
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