Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial

No AccessJournal of UrologyAdult Urology17 Nov 2023Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical TrialThis article is commented on by the following:Editorial Comment Badar M. Mian, Paul J. Feustel, Asef Aziz, Ronald P. Kaufman, Adrien Bernstein, Svetlana Avulova, and Hugh A.G. Fisher Badar M. MianBadar M. Mian *Corresponding Author: Badar M. Mian, Department of Urology, Albany Medical Center, 23 Hackett Blvd, Albany, NY 12208 E-mail Address: [email protected] https://orcid.org/0000-0002-1698-9525 Department of Urology, Albany Medical Center, Albany, New York More articles by this author , Paul J. FeustelPaul J. Feustel Department of Research Administration, Albany Medical Center, Albany, New York More articles by this author , Asef AzizAsef Aziz Department of Urology, Albany Medical Center, Albany, New York More articles by this author , Ronald P. KaufmanRonald P. Kaufman Department of Urology, Albany Medical Center, Albany, New York More articles by this author , Adrien BernsteinAdrien Bernstein Department of Urology, Albany Medical Center, Albany, New York More articles by this author , Svetlana AvulovaSvetlana Avulova Department of Urology, Albany Medical Center, Albany, New York More articles by this author , and Hugh A.G. FisherHugh A.G. Fisher Department of Urology, Albany Medical Center, Albany, New York More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003788AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: Transrectal prostate biopsy has come under scrutiny due to potential for postbiopsy infections and transperineal prostate biopsy is being offered as the safer alternative. However, there is a lack of randomized comparative studies. Our goal was to directly evaluate infectious and noninfectious complications following the 2 biopsy procedures. Materials and Methods: We conducted a prospective, pragmatic, randomized clinical study in men undergoing prostate biopsy. The participants underwent either transrectal or transperineal prostate biopsy in the office under local anesthesia. The primary outcome was a 30-day composite infectious complication rate, comprising of 1 or more components including fever, genitourinary infection, antibiotic prescriptions, office or emergency visits, hospitalization, or sepsis. Secondary outcomes included 30-day composite noninfectious complications (urinary or hemorrhagic). Results: Of the 763 randomized participants, 718 underwent either transrectal (351) or transperineal (367) prostate biopsy. A composite infectious complication event occurred in 9 participants (2.6%) in the transrectal and 10 participants (2.7%) in the transperineal group (odds ratio, 1.06; 95% CI, 0.43 to 2.65; P = .99). None of the participants developed sepsis in either group. There were no between-group differences in any of the individual component infectious events. A composite noninfectious complication occurred in 6 (1.7%) and 8 (2.2%) participants in the transrectal and transperineal groups, respectively (odds ratio, 1.28; 95% CI, 0.44 to 3.73; P = .79). No participants required hospitalization or other interventions. Conclusions: Among men undergoing transperineal or transrectal prostate biopsy, we could not demonstrate any difference in the infectious or noninfectious complications. Both biopsy approaches remain clinically viable and safe. REFERENCES 1. . MRI-targeted, systematic, and combined biopsy for prostate cancer diagnosis. N Engl J Med.2020; 382(10):917-928. 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Author Contributions: Conception and design: B.M.M., P.J.F., R.P.K., H.A.G.F.; Data analysis and interpretation: B.M.M., P.J.F., A.A., A.B., S.A.; Data acquisition: A.B.; Critical revision of the manuscript for scientific and factual content: B.M.M., P.J.F., A.A., R.P.K., A.B., S.A., H.A.G.F.; Drafting the manuscript: B.M.M., A.A., A.B.; Statistical analysis: P.J.F., A.A.; Supervision: B.M.M., R.P.K., A.B., S.A., H.A.G.F. Data Availability: The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited by Boesen L, Nørgaard N, Bisbjerg R, Al-Hamadani M, Sjölin C and Løgager V (2024) Office-based Magnetic Resonance Imaging–guided Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Real-world Clinical Utility StudyEuropean Urology Open Science, 10.1016/j.euros.2023.12.002, VOL. 59, (71-77), Online publication date: 1-Jan-2024. Siemens D and Wan J Editors’ Choice: February 2024Journal of Urology, Nusbaum D, Sidana A and Modi P Editorial CommentJournal of Urology, Related articlesJournal of Urology30 Nov 2023Editorial Comment Supplementary Materials Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.KeywordsprostatebiopsyinfectionbleedingcomplicationsMetrics Author Information Badar M. Mian Department of Urology, Albany Medical Center, Albany, New York *Corresponding Author: Badar M. Mian, Department of Urology, Albany Medical Center, 23 Hackett Blvd, Albany, NY 12208 E-mail Address: [email protected] More articles by this author Paul J. Feustel Department of Research Administration, Albany Medical Center, Albany, New York More articles by this author Asef Aziz Department of Urology, Albany Medical Center, Albany, New York More articles by this author Ronald P. Kaufman Department of Urology, Albany Medical Center, Albany, New York More articles by this author Adrien Bernstein Department of Urology, Albany Medical Center, Albany, New York More articles by this author Svetlana Avulova Department of Urology, Albany Medical Center, Albany, New York More articles by this author Hugh A.G. Fisher Department of Urology, Albany Medical Center, Albany, New York More articles by this author Expand All Support: None. Conflict of Interest Disclosures: The Authors have no conflicts of interest to disclose. Ethics Statement: This study received Institutional Review Board approval (IRB No. 5479). Author Contributions: Conception and design: B.M.M., P.J.F., R.P.K., H.A.G.F.; Data analysis and interpretation: B.M.M., P.J.F., A.A., A.B., S.A.; Data acquisition: A.B.; Critical revision of the manuscript for scientific and factual content: B.M.M., P.J.F., A.A., R.P.K., A.B., S.A., H.A.G.F.; Drafting the manuscript: B.M.M., A.A., A.B.; Statistical analysis: P.J.F., A.A.; Supervision: B.M.M., R.P.K., A.B., S.A., H.A.G.F. Data Availability: The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request. Advertisement PDF downloadLoading ...