Objective: To assess the complication rates and quality of life in patients eligible for focal therapy who underwent template-assisted transperineal prostate biopsy (TTPB). Materials and Methods: Eighty-seven patients with low-risk prostate cancer (clinical stage T1c-T2a, prostate-specific antigen level ≤10 ng/mL, biopsy Gleason score ≤6), who were candidates for focal therapy, underwent TTPB. The study details are available from http://clinicaltrials.gov (NCT00928603). The primary outcomes were the complication rates, according to the Clavien-Dindo classification, and changes in the quality of life, evaluated using the International Prostate Symptom Score, International Index of Erectile Function, and Functional Assessment of Cancer Therapy-Prostate questionnaires, before and 1 month after TTPB. Results: The median patient age was 63.9 years (range 46-78), with a median Charlson comorbidity index of 2.2 (range 0-4). No statistically significant differences were observed when comparing the general and/or specific domains of the International Prostate Symptom Score, International Index of Erectile Function, and Functional Assessment of Cancer Therapy-Prostate results before and 1 month after TTPB (P >.05 for all). Using the Clavien-Dindo classification, we observed 37 cases of grade 1 complications, including 5 (6.1%) cases of macrohematuria, 13 (16%) of hemospermia, 11 (13.5%) of perineal hematoma, 3 (3.7%) of perineal hematoma and hemospermia, and 5 (6.1%) of macrohematuria and hemospermia. Three patients (3.7%) developed a grade II complication (ie, acute urinary retention). Prostate cancer was detected in 54 patients (62.1%). Of 57 patients, 16 (29.6%) were upgraded from Gleason score 3+3/atypical small acinar proliferation to Gleason score 7. Of the 54 patients with positive TTPB findings, 18 (25.3%) showed an anatomic correspondence between the results of previous biopsies and TTPB. Conclusion: TTPB did not appear to have a significant effect on the quality of life of candidates for focal therapy, and the Clavien-Dindo complication rate was negligible.
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