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Objectives: To compare both the acceptability and the complications of prostate biopsy between men attending screening and hospital-referred symptomatic patients. A screening program cannot be successful unless the screening and diagnostic examinations are well tolerated and the willingness to participate is high., Methods: A total of 200 men, comprising 100 participants in the Finnish prostate cancer screening trial and 100 hospital-referred patients with signs or symptoms suggestive of prostate cancer, were consecutively recruited and underwent transrectal ultrasound-guided prostate biopsies. Immediate complications were recorded at the time of examination. Acceptance and possible late complications of biopsy were requested through a self-administered questionnaire, which was returned by 97% of those screened and 84% of the hospital-referred controls., Results: No major complications were seen immediately after biopsy, but one half of the men had minor rectal hemorrhage and, in a few cases, bleeding from the urethra. Most screened (58%) and hospital-referred (65%) subjects felt no distress before biopsy. The procedure was considered unpleasant by 69% of those screened and 61% of the controls. Correspondingly, 52% and 63% of men reported moderate pain at biopsy, but only 3 of those screened (3%) and 4 controls (5%) experienced severe pain. Nevertheless, a great majority of men in both the screening (82%) and the control (86%) groups would be willing to undergo a repeated biopsy if needed. Persistent rectal bleeding and hematuria were common (13% to 35%, respectively), but less than one fourth considered this disturbing. No significant differences were seen either in complications or acceptability between the groups., Conclusions: The results of our study demonstrated that minor complications are equally frequent among men undergoing prostate biopsy for screening and other men. Despite the complications, prostate biopsy was regarded as acceptable. Nevertheless, such complications may impair the acceptability, and eventually, the effectiveness of screening.