Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial

PRIMARY OBJECTIVE: I. To determine whether daily, real-time adaptive SBRT to the prostate improves acute patient-reported genitourinary (GU) toxicity when compared with conventional, non-adaptive SBRT to the prostate for localized prostate cancer. SECONDARY OBJECTIVES: I. To determine whether there are differences in the acute, patient-reported other toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer. II. To determine whether there are chronic differences in patient-reported quality of life (QOL) outcomes following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer. III. To determine whether there are differences in the acute and late physician-scored GU and gastrointestinal (GI) toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer. IV. To determine whether there are differences in the 5-year biochemical recurrence-free survival (BCRFS) following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer. CORRELATIVE OBJECTIVE: I. To correlate patient-reported and physician-scored toxicity with a commercially available genetic biomarker (PROSTOX trademark, MiraDx, Los Angeles, CA). OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or once daily (QD) for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. ARM 2: Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MRI and CT during screening and blood sample collection throughout the trial. After completion of study treatment, patients are followed up at months 1, 3, 6, 9, 12, 24, 36, 48, and 60.