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Completed

NCT Number: NCT05589558

Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)

Procedure

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).

Primary outcomes

  1. Clinically significant prostate cancer detection rate

    Time frame: 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 outcomes

  1. Overall prostate cancer detection rate

    Time frame: 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

  2. Clinically insignificant prostate cancer detection rate

    Time frame: 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

  3. Positive biopsy cores' number

    Time frame: 2 weeks after performed 4 biopsy methods

    Ratio of cores with detected prostate cancer in relation to overall numbers of cores

  4. Maximum cancer core length

    Time frame: 2 weeks after performed 4 biopsy methods

    Median length of core with prostate cancer in realtion to whole biopsy core

  5. Number of missed clinically significant prostate cancer

    Time frame: 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

  6. Added value of prostate cancer

    Time frame: 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

  7. Predicting factors of PCa detection

    Time frame: 2 weeks after performed 4 biopsy methods

    Prognostic factors of clinically significant and overall prostate cancer detection rate

  8. Comparison of biopsies and post-prostatectomy pathological results

    Time frame: 2 weeks after radical prostatectomy

    Gleason score obtained within biopsy and the post-prostatectomy pathology

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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