MRI-guided radiotherapy for prostate cancer: the MOMENTUM study 113 regardless of the CTV shift (i.e. always ATP). Androgen deprivation therapy (ADT) prescription was at the discretion of the treating physician and varied across institutions. Statistical analysis Outcomes included PSA kinetics during FU, physician-reported toxicity (CTCAE), and PROs at baseline, 3, 6, and 12 months FU. Descriptive statistics were provided for patient characteristics. Normally distributed data was presented as mean with 95% confidence intervals (CI). Skewed data was presented as median with range or interquartile range (IQR). For PSA level, CTCAE grades, and PRO scores, paired comparisons between baseline and 3, 6, and 12 months FU were performed using the Wilcoxon signed-rank test. For each comparison, the effect size (ES) was calculated. Analyses were performed for the total population and after stratification for use of ADT. A p-value < 0.05 was considered statistically significant. An ES < 0.30 was considered small, 0.30 – 0.49 moderate, and ³ 0.50 large.16 All analyses were performed using R version 4.1.2. Results Four-hundred-and-twenty-five prostate cancer patients within MOMENTUM, who had completed their radiotherapy treatment, were included. An ATS workflow was adopted in 310 (72.9%) patients and an ATP-only workflow in the remaining 115 (27.1%) patients. Three months FU was reached by 365 patients, 6 months FU by 313 patients, and 12 months FU by 186 patients. PSA values were available for 423 (99.5%) patients at baseline, 271 (74.2%) patients at 3 months FU, 223 (71.2%) patients at 6 months FU, and 117 (62.9%) patients at 12 months FU. Prospective CTCAE data was available for 227 (53.4%) patients at baseline, 177 (48.5%) patients at 3 months FU, 120 (38.3%) patients at 6 months FU, and 62 (33.3%) patients at 12 months FU. In total, 362 (85.2%) patients consented to fill out PRO questionnaires. The response rate of the PRO questionnaires was 85.4% at baseline, 80.2% at 3 months, 78.6% at 6 months, and 72.6% at 12 months FU. The median (range) age was 70 (51-85) years. Most patients had intermediate-risk prostate cancer (n = 337, 82.0%) followed by low-risk (n = 47, 11.4%) and high-risk (n = 27, 6.6%) according to the National Comprehensive Cancer Network (NCCN) risk groups (Table 1). Seventy-eight (18.4%) patients received ADT. A significant decline in median (IQR) PSA level was observed from baseline to 12 months FU of 7.8 (5.6-10.6) ng/mL to 1.2 (0.7-2.0) ng/mL in the non-ADT group and from 8.7 (5.9-13.0) ng/mL to 0.1 (0.1-0.4) ng/mL in the ADT group (Figure 1 and Table S2 in Supplementary B). Physician-reported toxicity Grade 1 and 2 GI toxicity was significantly higher at 3 months FU (17.5% and 1.7%, respectively) compared to baseline (6.2% and 0.9%, respectively, p < 0.001) (Table 2). At 6 and 12 months FU, no significant difference with baseline GI toxicity was observed. GU toxicity increased significantly to a rate of 37.3%grade 1, 18.1%grade 2, and 0.6%grade 3 toxicity at 3months (p < 0.001). No statistically 6
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