Timo Soeterik

31 Active Surveillance: Patient Selection BACKGROUND To be selected for active surveillance (AS) in the largest prospective cohort studies, patients with prostate cancer (PCa) need to meet several inclusion criteria. However, men who harbour higher-risk disease and do not meet all these selection criteria, may also opt for AS. Selecting higher-risk patients for AS may be based on various reasons including, for example, a patient’s strong motivation to preserve urinary continence and erectile function. 1 The AS course and outcomes in (very) low-risk patients included in the ongoing AS studies are well described and understood. By contrast, less is known about the outcomes for patients with PCa who would not qualify for inclusion in one of the AS studies because of a higher-risk profile. To adequately inform higher-risk patients opting for AS about their prognosis, more information on intermediate- and long-term outcomes of “off-protocol” selected patients is required. In this study we evaluated the outcomes for a large cohort of men, including patients with higher-risk PCa, managed with AS. The inclusion criteria of the Prostate Cancer Research International Active Surveillance (PRIAS) study were used as a reference, since this protocol is acknowledged as standard practice in the Netherlands. 2 METHODS Study setting and data collection This study was conducted within the Santeon consortium, which comprises seven large nonacademic teaching hospitals. Patients were selected from the Santeon prostate cancer database, which consists of data retrospectively collected as a part of quality improvement initiatives. Data from six out of seven hospitals were available during the study period, since the seventh hospital recently joined the collaboration and data from this centre were not yet available. Included in the present study were patients diagnosed with PCa between January 1, 2008 and December 31, 2014 and treated with AS. Additional data on biochemical follow-up after radical treatment, histological and surgical outcomes of deferred radical prostatectomy, and metastasis rates were collected by abstractors with an academic background who were trained by the principal investigator (T.F.W.S.). Study data were collected and managed using the REDCap electronic data capture tool. 3 After data insertion by the data abstractors, all cases were verified by the principal investigator (T.F.W.S.). Patient population and outcome measures Patients were included if they were on AS, clearly distinguishing these patients from those who were managed conservatively without curative intent (“watchful waiting”). 4 Excluded from the study were patients aged ≥80 yr at diagnosis, patients with incidental 2