Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.

Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.

Inclusion criteria

• Males aged 18-75 years old
• PSA >1 ng/ml but <15 ng/ml
• Negative DRE
• Signed informed consent

Exclusion criteria

• Previous prostate biopsy or prostate surgery
• Previous prostate mpMRI
• Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
• Patients in the Texas Department of Criminal Justice (prisoners)
• Patients with acute urinary symptoms including urinary retention and urinary tract infection