This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
AUA/IPSS score is ≤ 15.
ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
Patient has baseline grade ≥3 GI or GU toxicity
Patient has had prior overlapping pelvic radiotherapy.
Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
Patient has node positive prostate cancer.
Single group
Daily adaptive SBRT with urethral sparing
DeviceThe radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.
Patient-reported acute urinary toxicity
Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
Freedom from biochemical recurrence
Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)
Patient-reported quality of life issues related to prostate cancer.
Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.
Patient-reported erectile dysfunction symptoms
Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.
Patient-reported urinary symptoms
Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.
Decipher prognostic ability
Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.
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