Original article
An initial negative round of targeted biopsies in men with highly suspicious multiparametric magnetic resonance findings does not exclude clinically significant prostate cancer—Preliminary experience

https://doi.org/10.1016/j.urolonc.2016.11.006Get rights and content

Highlights

  • A negative targeted biopsy does not exclude significant PCa in men with highly suspicious mpMRI findings.

  • A posttargeted prostate biopsy imaging-pathology reconciliation is crucial.

  • Men with imaging-pathology discordant findings should follow a strict surveillance algorithm.

Abstract

Background

Targeted prostate biopsies are changing the landscape of prostate cancer (PCa) diagnosis with the degree of suspicion on multiparametric magnetic resonance imaging (mpMRI) being a strong predictor of targeted biopsy outcome. Data regarding the rate and potential causes of false-negative magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion–targeted biopsy in patients with highly suspicious mpMRI findings are lacking.

Objectives

To determine the rate of clinically significant PCa detection in repeat targeted biopsy or surgery in patients with highly suspicious mpMRI findings and in an initial negative MRI-TRUS fusion–targeted biopsy.

Materials and methods

In this single-center, retrospective study of prospectively generated data, men with highly suspicious lesions (Likert 5 score) on mpMRI and an initial negative MRI-TRUS fusion–targeted biopsy were reviewed. The rate of PCa detection in a subsequent MRI-TRUS fusion–targeted biopsy or radical prostatectomy was determined. Tumors in the intermediate- and high-risk groups according to the National Comprehensive Cancer Network criteria were considered clinically significant.

Results

A total of 32 men with 38 Likert 5 lesions were identified. Repeat targeted biopsy or surgery detected cancer in 42% (16/38) of the Likert 5 lesions with initial negative targeted biopsy. Most of these cancers were intermediate- (69%; 11/16) or high-risk (25%; 4/16) tumors.

Conclusion

A negative round of targeted biopsies does not exclude clinically significant PCa in men with highly suspicious mpMRI findings. Patients with imaging-pathology disagreement should be carefully reviewed and considered for repeat biopsy or for strict surveillance.

Introduction

Targeted prostate biopsies are changing the landscape of prostate cancer (PCa) diagnosis and have shown to improve the detection of clinically significant PCa [1]. Software-based magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion systems that overlay MRI findings on the TRUS screen distinguish themselves by combining efficiency and lower cost compared to direct, in-bore MRI guidance, and by improved accuracy compared to cognitive MRI-TRUS image fusion [2].

The performance of software-based MRI-TRUS fusion is dependent on the acquisition of high-quality multiparametric magnetic resonance (MR) images, adequate MR interpretation, MR image segmentation (i.e., prostate contouring and target delineation), ultrasound (US) image segmentation of prostate boundaries, fusion of MR and US images, precise target sampling based on navigation of fused images, adequate tissue samples, and sound histological interpretation [3]. Deficiencies in one or more of these multiple steps may compromise the accuracy of targeted biopsies using this approach.

The degree of suspicion on multiparametric MRI (mpMRI) is the strongest predictor of a positive targeted biopsy with positive rates of 70% to 90% when the MRI findings are highly suspicious for PCa (i.e., PI-RADS or Likert score of 5) [4], [5], [6], [7], [8], [9], [10], [11]. Thus, a negative targeted biopsy of a highly suspicious lesion on mpMRI must be interpreted with caution and additional actions (e.g., repeat biopsy and imaging follow-up) may be required depending on the clinical context. However, data regarding the rate and potential causes of false-negative MRI-TRUS fusion–targeted biopsy in patients with highly suspicious mpMRI findings are lacking.

Hence, the goal of this study was to determine the rate of clinically significant PCa detection in repeat targeted biopsy or surgery in patients with highly suspicious mpMRI findings and an initial negative targeted biopsy. Secondarily, we aimed to determine potential reasons for failures and features associated with an increased risk of a falsely negative targeted biopsy.

Section snippets

Materials and methods

This Institutional Review Board–approved and Health Insurance Portability and Accountability Act–compliant study is a retrospective collection and analysis of prospectively generated clinical, imaging, and histopathological data.

Results

A total of 122 men with 150 lesions met eligibility criteria (Fig. 1), with mean and standard deviation age of 68±7 years, PSA of 9.4±±7.3 ng/ml, lesion size of 15±7 mm, prostate volume of 62±30 cc, and interval between initial and repeat targeted biopsy or surgery of 74±50 days. Of these biopsies, 81% (99/122) were performed by 2 more-experienced and 19% (23/122) were performed by 2 less-experienced biopsy operators. Among the 32 men with 38 Likert 5 lesions who had an initial negative targeted

Discussion

Most men (74%; 90/122) with Likert 5 lesions have PCa detected on initial MRI-TRUS fusion–targeted biopsy. Equally relevant is that at least 42% of the Likert 5 lesions with a negative initial MRI-TRUS fusion biopsy have missed cancer, of which most represent clinically significant disease. As such, one needs to strongly consider re-biopsy in men with Likert 5 lesions and a re-evaluation of the MRI and ultrasound fusion for technical issues that may have resulted in a false-negative biopsy.

Conclusions

Our preliminary experience suggests that a negative round of targeted MRI-TRUS fusion biopsy does not exclude clinically significant PCa in patients with highly suspicious mpMRI findings. Therefore, a postbiopsy imaging-pathology reconciliation is critical and patients with discordant findings should be carefully reviewed and entered into a formal repeat biopsy/follow-up management algorithm. Future studies should investigate the role of early repeat targeted biopsy, the differences across

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    This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, United States (Grant no. UL1TR001105).

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