Magnetic Resonance Imaging/Ultrasound–Fusion Biopsy Significantly Upgrades Prostate Cancer Versus Systematic 12-core Transrectal Ultrasound Biopsy

doi:10.1016/j.eururo.2013.05.059

European Urology

Volume 64, Issue 5, November 2013, Pages 713-719

https://doi.org/10.1016/j.eururo.2013.05.059 Get rights and content

Abstract

Background

Gleason scores from standard, 12-core prostate biopsies are upgraded historically in 25−33% of patients. Multiparametric prostate magnetic resonance imaging (MP-MRI) with ultrasound (US)-targeted fusion biopsy may better sample the true gland pathology.

Objective

The rate of Gleason score upgrading from an MRI/US-fusion-guided prostate-biopsy platform is compared with a standard 12-core biopsy regimen alone.

Design, setting, and participants

There were 582 subjects enrolled from August 2007 through August 2012 in a prospective trial comparing systematic, extended 12-core transrectal ultrasound biopsies to targeted MRI/US-fusion-guided prostate biopsies performed during the same biopsy session.

Outcome measurements and statistical analysis

The highest Gleason score from each biopsy method was compared.

Interventions

An MRI/US-fusion-guided platform with electromagnetic tracking was used for the performance of the fusion-guided biopsies.

Results and limitations

A diagnosis of prostate cancer (PCa) was made in 315 (54%) of the patients. Addition of targeted biopsy led to Gleason upgrading in 81 (32%) cases. Targeted biopsy detected 67% more Gleason ≥4 + 3 tumors than 12-core biopsy alone and missed 36% of Gleason ≤3 + 4 tumors, thus mitigating the detection of lower-grade disease. Conversely, 12-core biopsy led to upgrading in 67 (26%) cases over targeted biopsy alone but only detected 8% more Gleason ≥4 + 3 tumors. On multivariate analysis, MP-MRI suspicion was associated with Gleason score upgrading in the targeted lesions (p < 0.001). The main limitation of this study was that definitive pathology from radical prostatectomy was not available.

Conclusions

MRI/US-fusion-guided biopsy upgrades and detects PCa of higher Gleason score in 32% of patients compared with traditional 12-core biopsy alone. Targeted biopsy technique preferentially detects higher-grade PCa while missing lower-grade tumors.

Introduction

Pathologic grading of prostate cancer (PCa) based on biopsy Gleason score (bGS) plays an important role in clinical decision making. Unfortunately, a number of studies have identified a poor correlation between the Gleason score identified on prostate biopsy and that found in the prostatectomy specimen, with rates of Gleason score upgrading between 21% and 54% [1], [2], [3]. Cookson and colleagues have also reported a discrepancy of two or more grades in 26% of cases [4]. The challenge is that surgical-specimen Gleason scores are obtained too late (after the surgery) to influence decision making, algorithms, and triage that involve surgery.

Multiparametric prostate magnetic resonance imaging (MP-MRI) has emerged as an accurate modality in detecting PCa. Lesions identified on MP-MRI correlate with tumor location on radical prostatectomy specimens [5]. A similar study found that the level of radiologic suspicion based on MP-MRI findings correlates with the D’Amico risk stratification [6].

The ability to detect, delineate, and measure PCa on magnetic resonance imaging (MRI) has led to the development of three MRI-guided prostate biopsy methods: cognitive fusion, direct MRI-guided biopsy, and several methods of MRI/ultrasound (MRI/US)-fusion-guided biopsy [7]. Cognitive fusion involves an estimation of the location of the lesion on the part of the transrectal ultrasound (TRUS) operator and varies greatly with expertise. Direct MRI-guided biopsy is time consuming and resource costly. In contrast, MRI/US-fusion-guided biopsy is an outpatient procedure, in which prebiopsy MRI of the prostate is segmented, registered, and fused with real-time ultrasound using electromagnetic tracking or mechanical-arm navigation and a digital overlay. This method integrates well with current workflow patterns of TRUS-guided biopsy yet provides a platform for a targeted approach to prostate biopsy based on MRI-identified targets and lesions [8]. MRI/US-fusion-guided biopsy has the potential to offer improved diagnostic information over 12-core biopsy alone. To study whether MRI/US fusion results in more accurate biopsies, the correlation was assessed between the Gleason scores detected on MRI/US-fusion biopsy and those found on a standard 12-core TRUS biopsy performed during the same biopsy session.

Section snippets

Study population

Subjects were enrolled in a prospective trial assessing MRI/US-fusion-guided prostate biopsy with electromagnetic tracking at the US National Cancer Institute and the US National Institutes of Health between August 2007 and August 2012 (ClinicalTrials.gov identifier: NCT00102544). Institutional review board approval was obtained and all subjects provided written informed consent. During the study period, a total of 671 MRI/US-fusion-guided prostate biopsies were performed, including 89 patients

Results

Patient demographics of the study cohort are shown in Table 1. The mean age of the patient population was 61.3 yr and mean prebiopsy PSA level was 9.9 ng/ml. The mean number of targeted biopsies per patient was 5.7, and, accordingly, the mean total number of biopsies including the standard 12-cores was 17.7. Abnormal findings on TRUS were observed in 79 (14%) of subjects.

The rate of Gleason score upgrading with targeted MRI/US-fusion-guided prostate biopsy was compared with standard 12-core

Discussion

There has been considerable concern regarding overdiagnosis and subsequent overtreatment of men with clinically indolent PCa; thus, better characterization of PCa is highly desirable [14]. MRI/US-fusion-guided, targeted biopsies may potentially offer such an improvement [15]. An initial cohort in this same clinical trial previously demonstrated that MRI/US-fusion-guided targeted biopsy increased cancer detection rates significantly compared with standard 12-core TRUS biopsy alone, especially in

Conclusions

In this study, the rate of Gleason score upgrading with MRI/US-fusion-guided targeted biopsies was examined and a 32% rate of increased Gleason score was found when compared with standard extended 12-core biopsy alone. The converse relationship was also examined of 12-core biopsies as an adjunct to targeted biopsies alone and found a 26% rate of Gleason score upgrading. Most of these cases were due to new bGS 6 tumors that were detected; however, seven patients were upgraded to bGS ≥4 + 3

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Platinum Priority – Prostate CancerEditorial by Mark Emberton on pp. 720–721 of this issueMagnetic Resonance Imaging/Ultrasound–Fusion Biopsy Significantly Upgrades Prostate Cancer Versus Systematic 12-core Transrectal Ultrasound Biopsy

Abstract

Background

Objective

Design, setting, and participants

Outcome measurements and statistical analysis

Interventions

Results and limitations

Conclusions

Introduction

Section snippets

Study population

Results

Discussion

Conclusions

Urology

Eur Urol

J Urol

J Urol

J Urol

Eur Urol

J Urol

J Urol

Platinum Priority – Prostate Cancer
Editorial by Mark Emberton on pp. 720–721 of this issue
Magnetic Resonance Imaging/Ultrasound–Fusion Biopsy Significantly Upgrades Prostate Cancer Versus Systematic 12-core Transrectal Ultrasound Biopsy