Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

Prostate Cancer Clinical Trial

— ProBE-PC  

Official title:

Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081636
• Other study ID #: 5479
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Albany Medical College
• Contact: Brenda Romeo, CCRC
• Phone: 518-262-8579
• Email: amcurologyresearch[@]amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infection
• Infections
• Prostate Cancer
• PSA

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of infectious complications	Whether or not patient had an infection after the biopsy	30 days
Primary	Clinically significant cancer detection rate	The rate of grade group 2 prostate cancer detected in each study arm	14 days
Secondary	Rate of Bleeding complications	The type of bleeding and its severity (blood in urine or stool)	30 days
Secondary	Tolerability under local anesthesia	Pain scores; Need for additional analgesia	30 days
Secondary	Patient reported urinary function measures using IPSS questionaire	International Prostate Symptoms Score (IPSS) to measure urinary function	30 days
Secondary	Cost of the procedures	Differences in the actual cost of the procedures (including supplies, time)	30 days
Secondary	Patient reported sexual function measures using IIEF questionaire	International Index of Erectile Function (IIEF) to measure sexual dysfunction	30 days