European Urology European Urology 43 (2003) 327–332 Follow-UpofMenwithElevatedProstate-SpecificAntigen andOneSetofBenignBiopsiesatProstateCancerScreening Bjo ¨rn Zackrisson a,* , Gunnar Aus a , Hans Lilja b , Pa ¨r Lodding a , Carl-Gustaf Pihl c , Jonas Hugosson a a Department of Urology, Sahlgrenska University Hospital, Go ¨teborg, Sweden b Department of Clinical Chemistry, Malmo ¨ University Hospital, Malmo ¨, Sweden c Department of Pathology, Sahlgrenska University Hospital, Go ¨teborg, Sweden Accepted 17 January 2003 Abstract Objective: To study the follow-up of men with elevated prostate-specific antigen (PSA) (>3 ng/ml) after one benign set of sextant biopsies. From the Go ¨teborg branch of the European Randomised Study of Screening for Prostate Cancer (ERSPC). Method: 456 men with one set of benign sextant biopsies were followed every second year for 4 years with PSA determinations. In cases of elevated PSA, transrectal ultrasound (TRUS) guided sextant biopsies were suggested. Digital rectal examination (DRE), prostate volume, PSA, PSA density (PSAD) and the ratio between free and total PSA (PSA F/T) were recorded. Results: Complete data were available for 322 men. 3 groups were identified. In 84/322 (26%) men cancer was found (‘‘cancer’’ group). 182/322 (56%) had benign biopsies (‘‘benign’’ group) and 56/322 (17%) had normalised PSA (‘‘normalised PSA’’ group). Median prostate volumes were 36, 46, and 33 cc respectively in the three groups. DRE and/or TRUS were abnormal in only 30% of the men in all groups. Cancer was not found in any prostate >70 cc volume. In prostates of <20 cc either cancer was found or PSAwas normalised. The ‘‘normalised PSA’’ group had initial PSA, PSAD and PSA F/T similar to cancer, normalising during follow-up. Conclusions: Patients with one negative sextant biopsy still have a high likelihood of cancer, especially men with persistently elevated PSA and small prostates (<20 cc) while the majority of men with large prostates (>70 cc) have PSA elevation due to benign prostate hyperplasia (BPH) and not to cancer. # 2003 Elsevier Science B.V. All rights reserved. Keywords: Prostate; Neoplasm; Screening; Prostate-specific antigen; Free-to-total PSA (PSA ratio); PSA density; Transrectal ultrasound (TRUS); Re-biopsy 1. Introduction Prostate-specific antigen (PSA) has become widely used in the search for prostate cancer. In the clinical situation with an elevated PSA, the decision of when to proceed with a prostate biopsy or when it is safe to wait, is not always easy. The decision becomes even more difficult after one set of benign biopsies. The risks and the benefits of additional biopsies have to be weighted. Transrectal ultrasound (TRUS) guided core biopsies are invasive, sometimes painful and costly. The rate of mild to moderate complications is relatively high and rarely also severe complications may occur [1,2]. On the other hand, it has been demonstrated that repeated biopsies are associated with at least 10% probability of demonstrating cancer [3]. There is thus a need to find clinical tests or factors catalysing the decision-making process, selecting cases for biopsy more specific. * Corresponding author. Present address: Lundby Hospital, Wieselgrens- platsen 2A, 417 17 Go ¨teborg, Sweden. Tel. þ46-31-657008; Fax: þ46-31-657013. E-mail address: bjorn.zackrisson@lundbysjukhus.se (B. Zackrisson). 0302-2838/03/$ – see front matter # 2003 Elsevier Science B.V. All rights reserved. doi:10.1016/S0302-2838(03)00044-7