Timo Soeterik

37 Active Surveillance: Patient Selection Unfavourable outcomes after deferred radical prostatectomy Of all 588 patients who discontinued AS, 420 (71%) underwent curative treatment. Of these, 182/420 (43%) underwent radical prostatectomy. PRIAS-ineligible patients had a significantly higher risk of unfavourable histological outcomes (pathological T-stage ≥T3 and/or Gleason sum >7) and positive surgical margins after deferred prostatectomy (Table 4). Patients with a PSAD ≥0.2 had a higher risk of unfavourable pathological findings (OR 3.61, 95% CI 1.85 - 7.05), positive surgical margins (OR 1.97, 95% CI 1.03 - 3.79) and biochemical progression (OR 3.26, 95% CI 1.23 - 8.64) (Table 4). Association between off-protocol selection and risk of metastasis Median follow-up (period between date of diagnosis and last hospital visit/contact) of the cohort was 5.0 (IQR 3.5 - 6.6) years. During this follow-up period, 25 of the 1000 patients (2.5%) developed metastatic PCa. In contrast to our earlier results, PRIAS-ineligible patients did not have a higher risk of metastasis compared with the PRIAS-eligible patients (HR 1.37, 95% CI 0.62 - 3.01). However, the results for PSAD were in line with earlier outcomes, since patients with PSAD ≥0.2 also had a higher risk of metastasis compared with patients with a PSAD <0.2 ng/ml/ml (HR 2.71, 95% CI 1.23 - 5.96). Patients not complying with ≥2 PRIAS criteria also had a higher risk of metastasis (Table 5). In this cohort, at baseline, 57 patients had a PSAD ≥0.2 and >2 positive biopsy cores. In 7/57 (12%) of these patients, metastatic PCa was diagnosed. TABLE 5. Metastasis rates per predictor Predictor HR 95% CI p PSA >10 1.33 0.53 – 3.33 0.546 PSAD ≥0.2 2.71 1.23 – 5.96 0.014 Gleason sum ≥7 2.25 0.53 – 9.56 0.273 Positive cores >2 2.17 0.90 – 5.19 0.083 Non-PRIAS 1.37 0.62 – 3.01 0.438 Two or more criteria a 3.04 1.37 – 6.78 0.006 PSAD ≥0.2 and positive cores >2 6.17 2.57 – 14.82 <0.001 PSAD ≥0.2 and PSA >10 2.11 0.84 – 5.28 0.112 PSA >10 and positive cores >2 3.48 1.04 – 11.64 0.043 a Not meeting two or more of the PRIAS selection criteria at initial diagnosis. HR = hazard ratio. 2