Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with suspected prostate cancer underwent 4 biopsy methods 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)
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).
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Outcome Measures
Primary Outcome Measures
- Clinically significant prostate cancer detection rate [2 weeks after performed 4 biopsy methods]
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients
Secondary Outcome Measures
- Overall prostate cancer detection rate [2 weeks after performed 4 biopsy methods]
Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients
- Clinically insignificant prostate cancer detection rate [2 weeks after performed 4 biopsy methods]
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients
- Positive biopsy cores' number [2 weeks after performed 4 biopsy methods]
Ratio of cores with detected prostate cancer in relation to overall numbers of cores
- Maximum cancer core length [2 weeks after performed 4 biopsy methods]
Median length of core with prostate cancer in realtion to whole biopsy core
- Number of missed clinically significant prostate cancer [2 weeks after performed 4 biopsy methods]
Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies
- Added value of prostate cancer [2 weeks after performed 4 biopsy methods]
Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies
- Predicting factors of PCa detection [2 weeks after performed 4 biopsy methods]
Prognostic factors of clinically significant and overall prostate cancer detection rate
- Comparison of biopsies and post-prostatectomy pathological results [2 weeks after radical prostatectomy]
Gleason score obtained within biopsy and the post-prostatectomy pathology
Eligibility Criteria
Criteria
Inclusion Criteria:
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PSA >2 ng/mL, and/or positive digital rectal examination (DRE), and/or suspicious lesion on TRUS
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Pi-RADSv2.1 ≥3 score
Exclusion Criteria:
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previously diagnosed PCa;
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acute prostatitis within the last 3 months;
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5-α reductase inhibitors therapy within the last 6 months;
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extracapsular extension;
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prostate volume ≥80 cc;
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contraindications for mpMRI.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Urology and Reproductive Health, Sechenov University. | Moscow | Russian Federation | 119991 |
Sponsors and Collaborators
- I.M. Sechenov First Moscow State Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Sechenov-four_biopsies