Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

NCT04081636 | Completed

• 1 other identifier: 5479
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. 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.

Conditions

Prostate Cancer; PSA; Infection

Keywords

Prostate biopsy; PSA; infection; bleeding

Outcome Measures

Primary Outcomes (2)

• Rate of infectious complications

  Whether or not patient had an infection after the biopsy

  30 days

• Clinically significant cancer detection rate

  The rate of grade group 2 prostate cancer detected in each study arm

  14 days

Secondary Outcomes (5)

• Rate of Bleeding complications

  30 days

• Tolerability under local anesthesia

  30 days

• Patient reported urinary function measures using IPSS questionaire

  30 days

• Cost of the procedures

  30 days

• Patient reported sexual function measures using IIEF questionaire

  30 days

Study Arms (4)

Systematic Transrectal biopsy (TR-Bx)

ACTIVE COMPARATOR

Ultrasound guided; needle inserted through the rectum to reach the prostate

Procedure: Systematic Transrectal biopsy (TR-Bx)

Targeted Transrectal biopsy (TR-Bx)

ACTIVE COMPARATOR

MRI-guided; needle inserted through the rectum to reach the prostate

Procedure: Targeted Transrectal biopsy (TR-Bx)

Systematic Transperineal biopsy (TP-Bx)

EXPERIMENTAL

Ultrasound guided; needle inserted directly through the skin to reach the prostate

Procedure: Systematic Transperineal biopsy (TP-Bx)

Targeted Transperineal biopsy (TP-Bx)

EXPERIMENTAL

MRI-guided; needle inserted directly through the skin to reach the prostate

Procedure: Targeted Transperineal biopsy (TP-Bx)

Interventions

Systematic Transrectal biopsy (TR-Bx) PROCEDURE

Through the rectum

Also known as: ultrasound guided

Systematic Transrectal biopsy (TR-Bx)

Targeted Transrectal biopsy (TR-Bx) PROCEDURE

Through the rectum

Also known as: MRI guided

Targeted Transrectal biopsy (TR-Bx)

Systematic Transperineal biopsy (TP-Bx) PROCEDURE

Through the perineal skin

Also known as: ultrasound guided

Systematic Transperineal biopsy (TP-Bx)

Targeted Transperineal biopsy (TP-Bx) PROCEDURE

Through the perineal skin

Also known as: MRI guided

Targeted Transperineal biopsy (TP-Bx)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
• Either with or without an MRI

You may not qualify if:

• Patients with no access to rectum (due to previous rectal surgery)
• Any abnormalities of the perineal skin (e.g. infection)
• Patients whose procedure requires sedation or general anesthesia

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

Related Publications (15)

• 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.

  PMID: 30415878 BACKGROUND

• 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.

  PMID: 29552975 BACKGROUND

• 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.

  PMID: 28336078 BACKGROUND

• 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.

  PMID: 30271182 BACKGROUND

• 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.

  PMID: 27543165 BACKGROUND

• 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.

  PMID: 28363690 BACKGROUND

• 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.

  PMID: 27774521 BACKGROUND

• 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.

  PMID: 30760274 BACKGROUND

• 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.

  PMID: 29942197 BACKGROUND

• 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.

  PMID: 28007492 BACKGROUND

• 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.

  PMID: 29988098 BACKGROUND

• 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.

  PMID: 30835607 BACKGROUND

• 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.

  PMID: 29409845 BACKGROUND

• Mian BM, Kaufman RP Jr, Berstein A, Fisher HAG. Letter: Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial. J Urol. 2024 Sep;212(3):511-512. doi: 10.1097/JU.0000000000004081. Epub 2024 Jun 7. No abstract available.

  PMID: 38847318 DERIVED

• 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.

  PMID: 38700844 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Infections; Hemorrhage

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Badar M Mian, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Randomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate. Both arms, either with or without MRI guided biopsy

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 2, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)