Prostate Cancer Detection Rate in Patients with Repeated Extended 21-Sample Needle Biopsy

Abstract Background Prevalence of prostate cancer (PCa) after a negative first extended prostate needle biopsy protocol is unknown. Objective To evaluate the prevalence of significant PCa in patients who have had a negative first extended prostate biopsy protocol. Design, setting, and participants Between March 2001 and May 2007, 2500 consecutive patients underwent an extended protocol of 21 biopsies. Of 953 patients who had a negative first extended prostate biopsy procedure, 231 patients underwent a second or more set of 21-core biopsies. Indications for repeated biopsies were persistently elevated prostate-specific antigen (PSA), PSA increase during the follow-up, or prior prostatic intraepithelial neoplasia (PIN), or atypical small acinar proliferation (ASAP). Intervention All participants underwent at least two extended prostate needle biopsy protocols. Measurements Clinical and pathologic factors (age, PSA, PSA doubling time, PIN, ASAP, digital rectal exam [DRE]) were analyzed for their ability to predict positive biopsy, and tumour parameters were assessed in patients undergoing radical prostatectomy. Results and Limitations Second, third, and fourth extended 21-sample biopsy procedures yielded a diagnosis of PCa in 18%, 17%, and 14% of patients respectively. Patients with prior PIN had 16% risk of prostate cancer; patients with ASAP had a 42% risk. The mean number of positive cores was 2.19. Prostate volume and PSA density were statistically significant predictors of positive biopsy ( p < 0.05). For the 43 patients who underwent radical prostatectomy, pathologic findings revealed mean Gleason score of 6.7 (6–8), pT2a–c in 72%, pT3a in16%, and pT4 in 7%. Mean cancer volume was 1.15 cc and 85.2% of tumours were clinically significant (tumour volume >0.5 cc, Gleason ≥7 and/or pT3). Conclusions Negative first extended biopsies should not reassure a patient of not having PCa. However, prostate cancers detected after two or more sets of extended procedures, appear to be localized (intracapsular disease) and well-differentiated prostate cancers, although they are still clinically significant.