title: Complications and quality of life after template-assisted transperineal prostate biopsy in patients eligible for focal therapy.
abstract: OBJECTIVE
  To assess the complication rates and quality of life in patients eligible for focal therapy who underwent template-assisted transperineal prostate biopsy (TTPB).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, San Raffaele Turro Hospital, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Losa
authors.forename: Giulio Maria
authors.initials: GM
authors.lastname: Gadda
authors.forename: Massimo
authors.initials: M
authors.lastname: Lazzeri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lughezzani
authors.forename: Giampiero
authors.initials: G
authors.lastname: Cardone
authors.forename: Massimo
authors.initials: M
authors.lastname: Freschi
authors.forename: Giuliana
authors.initials: G
authors.lastname: Lista
authors.forename: Alessandro
authors.initials: A
authors.lastname: Larcher
authors.forename: Luciano Dante
authors.initials: LD
authors.lastname: Nava
authors.forename: Giorgio
authors.initials: G
authors.lastname: Guazzoni
mesh_terms: D000368:Aged; D001707:Biopsy, Needle / Q000009:adverse effects*; D016009:Chi-Square Distribution; D006406:Hematoma / Q000209:etiology; D006417:Hematuria / Q000209:etiology; D051516:Hemospermia / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D010502:Perineum; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000628:therapy; D011788:Quality of Life; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016055:Urinary Retention / Q000209:etiology