Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
prostate cancer, fusion biopsy, cognitive biopsy, transrectal ultrasound biopsy, transperineal template mapping biopsy
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.
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).
Interventions
PROCEDUREconsequently 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).
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The blinded urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Russia
Outcome results
None listed