Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Study Overview
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Brief Summary
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The aim of this study is to compare clinically significant prostate cancer detection rate by the 4 biopsy methods: TRUS-guided, cognitive, fusion and transperineal template mapping biopsy. It is recommended to combine MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) biopsy for high yield of prostate cancer diagnosis. Nevertheless, it remains unclear which biopsy combination is more precise for prostate cancer detection.

Detailed Description
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Taking into consideration the variety of prostate biopsy methods (TRUS-guided, cognitive, fusion and transperineal template mapping biopsy), the issue of indications for each of them remains unresolved. Current EAU guidelines recommend combining MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) one for high yield of prostate cancer diagnosis. Nevertheless, it also remains unclear which biopsy combination is more precise for prostate cancer detection. This is a prospective single-arm study. All patients underwent prostate TRUS examination and mpMRI. Suspicious lesion found on MRI were classified with the Pi-RADS v2.1. First step: the unblinded urologist №1 performed a fusion and transperineal template mapping biopsy. Second step: the blinded urologist №2 performed TRUS-guided and cognitive biopsy. Objectives of the study: to determine clinically significant prostate cancer detection rate, overall cancer detection rate, clinically insignificant prostate cancer detection rate, sampling efficiency (positive biopsy cores' number, maximum cancer core length (MCCL)). Results were calculated for each biopsy method separately and for combinations of TRUS-guided and cognitive biopsy (combination №1) and fusion and transperineal template mapping biopsy (combination №2).

Official Title
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Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Conditions
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Prostate Cancer, Prostate Adenocarcinoma

Intervention / Treatment
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* Procedure: consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PSA >2 ng/mL, and/or positive digital rectal examination (DRE), and/or suspicious lesion on TRUS Pi-RADSv2.1 ≥3 score Exclusion Criteria: previously diagnosed PCa; acute prostatitis within the last 3 months; 5-α reductase inhibitors therapy within the last 6 months; extracapsular extension; prostate volume ≥80 cc; contraindications for mpMRI.

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Interventional Model Description: First step: the unblinded urologist №1 performed a fusion and transpeineal template mapping biopsy. Second step: the blinded urologist №2 performed TRUS-guided and cognitive biopsy. All specimens were obtained within a single procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with suspected prostate cancer underwent 4 biopsy methods<br>Patients with suspected prostate cancer consequently underwent TRUS-guided, cognitive, fusion and transperineal template mapping biopsy | Procedure: consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)<br>* TRUS-guided biopsy - extensive number of biopsies taken transrectally involving peripheral and transitional zones (8-12 cores); cognitive biopsy - targeted biopsy with MRI information and TRUS guidance but without fusion technology (2-4 cores); fusion biopsy - targeted biopsy with MRI information using MRI/TRUS fusion technology (2-4 core); transperineal template mapping biopsy - systematic transperineal TRUS-guided biopsy with special template use to aid accurate placement of biopsy needles (more than 20 cores).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant prostate cancer detection rate | Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients | 2 weeks after performed 4 biopsy methods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall prostate cancer detection rate | Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients | 2 weeks after performed 4 biopsy methods | 
| Clinically insignificant prostate cancer detection rate | Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients | 2 weeks after performed 4 biopsy methods | 
| Positive biopsy cores' number | Ratio of cores with detected prostate cancer in relation to overall numbers of cores | 2 weeks after performed 4 biopsy methods | 
| Maximum cancer core length | Median length of core with prostate cancer in realtion to whole biopsy core | 2 weeks after performed 4 biopsy methods | 
| Number of missed clinically significant prostate cancer | Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies | 2 weeks after performed 4 biopsy methods | 
| Added value of prostate cancer | Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies | 2 weeks after performed 4 biopsy methods | 
| Predicting factors of PCa detection | Prognostic factors of clinically significant and overall prostate cancer detection rate | 2 weeks after performed 4 biopsy methods | 
| Comparison of biopsies and post-prostatectomy pathological results | Gleason score obtained within biopsy and the post-prostatectomy pathology | 2 weeks after radical prostatectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, fusion biopsy, cognitive biopsy, transrectal ultrasound biopsy, transperineal template mapping biopsy