Clinical trial NCT05589558: Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
Official title: Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: prostate cancer
fusion biopsy
cognitive biopsy
transrectal ultrasound biopsy
transperineal template mapping biopsy
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Clinically significant prostate cancer detection rate
timeFrame: 2 weeks after performed 4 biopsy methods
Secondary outcomes:
measure: Overall prostate cancer detection rate
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Clinically insignificant prostate cancer detection rate
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Positive biopsy cores' number
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Maximum cancer core length
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Number of missed clinically significant prostate cancer
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Added value of prostate cancer
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Predicting factors of PCa detection
timeFrame: 2 weeks after performed 4 biopsy methods
measure: Comparison of biopsies and post-prostatectomy pathological results
timeFrame: 2 weeks after radical prostatectomy
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
References:
citation: Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.