Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer

Acute and late Common Terminology Criteria for Adverse Events version 5.0 grade 2 or greater genitourinary and gastrointestinal toxicity will be recorded for all patients. Will report the overall grade 3+ toxicity rate along with a 95% confidence interval for this endpoint. Metrics related to treatment times for each fraction, physician choice of baseline vs adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well.

Measured by the successful completion of the daily adaptive radiation planning process, allowing the physician to choose this adaptive plan or the preexisting baseline plan. Successful completion of the daily adaptive radiation planning process will be recorded on a per fraction basis for each patient in the Ethos treatment planning system. Will be met if >= 90% of all fractions are completed. Metrics related to treatment times for each fraction, physician choice of baseline versus (vs) adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well. Will be reported descriptively, including the overall rates and 95% confidence intervals. The continuous variables will be compared between the groups (baseline vs adaptive plans) using the Wilcoxon Rank-Sum test and categorical variables will associated with the groups via chi-square tests. Graphical methods will be used as well, such as boxplots to display the continuous data

Local failure will be considered to have occurred if the patient develops a biopsy proven or radiographically confirmed site of recurrent disease within a planning target volume at any time following completion of protocol treatment. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

Biochemical failure is defined by prostate specific antigen (PSA) measurements following treatment. A biochemical failure will be declared if a patient's PSA rises more than 0.4 ng/ml above their post-radiation therapy nadir. Biochemical failure can also occur if a patient begins a new prostate cancer-directed therapy following radiation therapy prior to reaching the PSA threshold for biochemical failure. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

Distant metastasis is defined as radiographic or histologic confirmed disease progression within non-regional lymph nodes (M1a), bones, or visceral organs. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. 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 better Health Related Quality of Life. Will calculate the number of patients experiencing a minimally important difference (MID). MID will be considered a chance of >0.5 standard deviations from the pre-treatments median score within a specific domain.

EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. 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 better Health Related Quality of Life. Will measure changes in each domain and report these with 95% confidence intervals over time and associate outcomes with baseline variables.