Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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PSA, Prostate Cancer, Infection

Intervention / Treatment
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* Procedure: Systematic Transrectal biopsy (TR-Bx)
* Procedure: Targeted Transrectal biopsy (TR-Bx)
* Procedure: Systematic Transperineal biopsy (TP-Bx)
* Procedure: Targeted Transperineal biopsy (TP-Bx)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systematic Transrectal biopsy (TR-Bx)<br>Ultrasound guided; needle inserted through the rectum to reach the prostate | Procedure: Systematic Transrectal biopsy (TR-Bx)<br>* Through the rectum<br>* Other names: ultrasound guided;|
| Active Comparator: Targeted Transrectal biopsy (TR-Bx)<br>MRI-guided; needle inserted through the rectum to reach the prostate | Procedure: Targeted Transrectal biopsy (TR-Bx)<br>* Through the rectum<br>* Other names: MRI guided;|
| Experimental: Systematic Transperineal biopsy (TP-Bx)<br>Ultrasound guided; needle inserted directly through the skin to reach the prostate | Procedure: Systematic Transperineal biopsy (TP-Bx)<br>* Through the perineal skin<br>* Other names: ultrasound guided;|
| Experimental: Targeted Transperineal biopsy (TP-Bx)<br>MRI-guided; needle inserted directly through the skin to reach the prostate | Procedure: Targeted Transperineal biopsy (TP-Bx)<br>* Through the perineal skin<br>* Other names: MRI guided;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Bleeding complications | The type of bleeding and its severity (blood in urine or stool) | 30 days | 
| Tolerability under local anesthesia | Pain scores; Need for additional analgesia | 30 days | 
| Patient reported urinary function measures using IPSS questionaire | International Prostate Symptoms Score (IPSS) to measure urinary function | 30 days | 
| Cost of the procedures | Differences in the actual cost of the procedures (including supplies, time) | 30 days | 
| Patient reported sexual function measures using IIEF questionaire | International Index of Erectile Function (IIEF) to measure sexual dysfunction | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSA, Prostate biopsy, infection, bleeding