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

Not Applicable

Completed

Conditions: Clinically Significant Prostate Cancer
Transperineal
Fusion Biopsy
Magnetic Resonance Imaging
Target Lesion
Prostate Cancer

Interventions: Device: transrectal ultrasound-guided prostate biopsy
Device: MRI/ultrasound transperineal prostate biopsy

Registration Number: NCT03044197

Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary: Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transrectal ultrasound-guided prostate biopsy	transrectal ultrasound-guided prostate biopsy	TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.
MRI/ultrasound transperineal prostate biopsy	MRI/ultrasound transperineal prostate biopsy	In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS\<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Prostate Cancer	Within 2-4 wks after biopsy	Number of subjects with positive clinically significant prostate cancer results

Secondary Outcome Measures

Name	Time	Method
Comparison of UTI Incidence in Arm A mpMRI+ and Arm B	From the time of biopsy through 4 weeks post-biopsy	Number of confirmed UTIs
Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B	Within 2-4 wks from biopsy	Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.