Objective: To report on a cohort of patients with incidental prostate cancer (IPC) that was treated by an active surveillance (AS) protocol in the HAROW study. Materials and Methods: The HAROW study is an observational study on the management of localized prostate cancer in Germany. Treating urologists were reporting clinical parameters, information on therapy and clinical course of disease at 6-month intervals. Results: In total, 3,169 patients were enrolled. In 224 patients were found an IPC and 104 (46%) of them were put on an AS protocol. The mean follow-up was 26.5 months. Tumor progression was noted in 16 patients. In 11 patients, AS was replaced by a definite intervention. In univariate and multivariate analyses, only PSA density correlated with progression. Conclusion: This is the first prospective description of an IPC patient cohort on AS as part of an outcomes research study. AS was selected as a therapeutic strategy in nearly half of the patients (46%). Only a minor proportion (16%) displayed progression. Of the clinical parameters, only PSA density correlated with progression.

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