Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
NCT ID: NCT04081636
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
840 participants
INTERVENTIONAL
2019-09-02
2024-12-31
Brief Summary
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Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.
This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.
Detailed Description
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TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.
Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.
Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.
TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.
Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.
With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.
The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.
Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions:
* Differences in the risk of infectious complications
* Differences in the overall cancer detection rate and the high-grade cancer detection rate
* Differences in the hemorrhagic and urinary side effects
* Tolerability of both techniques with local anesthesia alone
* Difference in the results of of MRI/US fusion targeted biopsy
* Differences in the cost of the procedures
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Both arms, either with or without MRI guided biopsy
DIAGNOSTIC
DOUBLE
Study Groups
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Systematic Transrectal biopsy (TR-Bx)
Ultrasound guided; needle inserted through the rectum to reach the prostate
Systematic Transrectal biopsy (TR-Bx)
Through the rectum
Targeted Transrectal biopsy (TR-Bx)
MRI-guided; needle inserted through the rectum to reach the prostate
Targeted Transrectal biopsy (TR-Bx)
Through the rectum
Systematic Transperineal biopsy (TP-Bx)
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Systematic Transperineal biopsy (TP-Bx)
Through the perineal skin
Targeted Transperineal biopsy (TP-Bx)
MRI-guided; needle inserted directly through the skin to reach the prostate
Targeted Transperineal biopsy (TP-Bx)
Through the perineal skin
Interventions
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Systematic Transrectal biopsy (TR-Bx)
Through the rectum
Targeted Transrectal biopsy (TR-Bx)
Through the rectum
Systematic Transperineal biopsy (TP-Bx)
Through the perineal skin
Targeted Transperineal biopsy (TP-Bx)
Through the perineal skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Either with or without an MRI
Exclusion Criteria
* Any abnormalities of the perineal skin (e.g. infection)
* Patients whose procedure requires sedation or general anesthesia
MALE
No
Sponsors
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Albany Medical College
OTHER
Responsible Party
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Badar M. Mian
Professor of Surgery
Principal Investigators
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Badar M Mian, MD
Role: PRINCIPAL_INVESTIGATOR
Albany Medical College
Locations
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Albany Medical College
Albany, New York, United States
Countries
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References
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Choi YH, Kang MY, Sung HH, Jeon HG, Chang Jeong B, Seo SI, Jeon SS, Kim CK, Park BK, Lee HM. Comparison of Cancer Detection Rates Between TRUS-Guided Biopsy and MRI-Targeted Biopsy According to PSA Level in Biopsy-Naive Patients: A Propensity Score Matching Analysis. Clin Genitourin Cancer. 2019 Feb;17(1):e19-e25. doi: 10.1016/j.clgc.2018.09.007. Epub 2018 Sep 13.
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
Wu YP, Li XD, Ke ZB, Chen SH, Chen PZ, Wei Y, Huang JB, Sun XL, Xue XY, Zheng QS, Xu N. Risk factors for infectious complications following transrectal ultrasound-guided prostate biopsy. Infect Drug Resist. 2018 Sep 17;11:1491-1497. doi: 10.2147/IDR.S171162. eCollection 2018.
Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
Liss MA, Ehdaie B, Loeb S, Meng MV, Raman JD, Spears V, Stroup SP. An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy. J Urol. 2017 Aug;198(2):329-334. doi: 10.1016/j.juro.2017.01.103. Epub 2017 Mar 29.
Saade EA, Suwantarat N, Zabarsky TF, Wilson B, Donskey CJ. Fluoroquinolone-Resistant Escherichia coli Infections After Transrectal Biopsy of the Prostate in the Veterans Affairs Healthcare System. Pathog Immun. 2016;1(2):243-257. doi: 10.20411/pai.v1i2.123.
Xiang J, Yan H, Li J, Wang X, Chen H, Zheng X. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019 Feb 13;17(1):31. doi: 10.1186/s12957-019-1573-0.
Skouteris VM, Crawford ED, Mouraviev V, Arangua P, Metsinis MP, Skouteris M, Zacharopoulos G, Stone NN. Transrectal Ultrasound-guided Versus Transperineal Mapping Prostate Biopsy: Complication Comparison. Rev Urol. 2018;20(1):19-25. doi: 10.3909/riu0785.
Roberts MJ, Bennett HY, Harris PN, Holmes M, Grummet J, Naber K, Wagenlehner FME. Prostate Biopsy-related Infection: A Systematic Review of Risk Factors, Prevention Strategies, and Management Approaches. Urology. 2017 Jun;104:11-21. doi: 10.1016/j.urology.2016.12.011. Epub 2016 Dec 19.
Altok M, Kim B, Patel BB, Shih YT, Ward JF, McRae SE, Chapin BF, Pisters LL, Pettaway CA, Kim J, Demirel HC, Davis JW. Cost and efficacy comparison of five prostate biopsy modalities: a platform for integrating cost into novel-platform comparative research. Prostate Cancer Prostatic Dis. 2018 Nov;21(4):524-532. doi: 10.1038/s41391-018-0056-7. Epub 2018 Jul 9.
Stefanova V, Buckley R, Flax S, Spevack L, Hajek D, Tunis A, Lai E, Loblaw A; Collaborators. Transperineal Prostate Biopsies Using Local Anesthesia: Experience with 1,287 Patients. Prostate Cancer Detection Rate, Complications and Patient Tolerability. J Urol. 2019 Jun;201(6):1121-1126. doi: 10.1097/JU.0000000000000156.
Meyer AR, Joice GA, Schwen ZR, Partin AW, Allaf ME, Gorin MA. Initial Experience Performing In-office Ultrasound-guided Transperineal Prostate Biopsy Under Local Anesthesia Using the PrecisionPoint Transperineal Access System. Urology. 2018 May;115:8-13. doi: 10.1016/j.urology.2018.01.021. Epub 2018 Feb 1.
Mian BM, Feustel PJ, Aziz A, Kaufman RP Jr, Bernstein A, Fisher HAG. Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial. J Urol. 2024 Jul;212(1):21-31. doi: 10.1097/JU.0000000000003979. Epub 2024 May 3.
Other Identifiers
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5479
Identifier Type: -
Identifier Source: org_study_id