OBJECTIVES: To estimate the country-specific incidence of men with lower-risk (early-stage or localized) prostate cancer where imperfect diagnostic information makes the decision to perform radical prostatectomy (RP) uncertain. RP is indicated only when early-stage tumors are fast growing or when localized prostate cancer is strictly intra-capsular, neither of which can be accurately determined with available diagnostic technology. METHODS: We defined early-stage prostate cancer (PC) as TNM stage T1-2, N0, M0 with PSA =10 ng/Ml and Gleason score = 7, and localized PC as TNM stage T2, N0, M0. Next, we developed models for estimating the number of men in these two groups for the US, European Union (EU) and Japan. Finally, we populated these models with information derived from a comprehensive review of incidence and staging estimates from English-language literature and publicly available demographic and registry data. RESULTS: We identified over 100 relevant abstracts that yielded 67 manuscripts for review, 15 of which provided data for the model. The estimated number of newly diagnosed men with early-stage PC was 120,000 (US), 140,000 (EU), and 4,300 (Japan). The corresponding incidence rates per 100,000 males were 85, 58 and 7, respectively. The estimated number (incidence) of newly diagnosed men with localized PC was 89,000 (63), 71,000 (29) and 10,000 (15) in the US, EU and Japan, respectively. CONCLUSION: The number of men at risk for over- or under-utilization of radical prostatectomy due to inadequate diagnostic information is substantial and varies widely by country.