Elsevier

European Urology

Volume 75, Issue 2, February 2019, Pages 310-318
European Urology

Prostate Cancer
Prediction of High-grade Prostate Cancer Following Multiparametric Magnetic Resonance Imaging: Improving the Rotterdam European Randomized Study of Screening for Prostate Cancer Risk Calculators

https://doi.org/10.1016/j.eururo.2018.07.031Get rights and content

Abstract

Background

The Rotterdam European Randomized Study of Screening for Prostate Cancer risk calculators (ERSPC-RCs) help to avoid unnecessary transrectal ultrasound-guided systematic biopsies (TRUS-Bx). Multivariable risk stratification could also avoid unnecessary biopsies following multiparametric magnetic resonance imaging (mpMRI).

Objective

To construct MRI-ERSPC-RCs for the prediction of any- and high-grade (Gleason score ≥3 + 4) prostate cancer (PCa) in 12-core TRUS-Bx ± MRI-targeted biopsy (MRI-TBx) by adding Prostate Imaging Reporting and Data System (PI-RADS) and age as parameters to the ERSPC-RC3 (biopsy-naïve men) and ERSPC-RC4 (previously biopsied men).

Design, setting, and participants

A total of 961 men received mpMRI and 12-core TRUS-Bx ± MRI-TBx (in case of PI-RADS ≥3) in five institutions. Data of 504 biopsy-naïve and 457 previously biopsied men were used to adjust the ERSPC-RC3 and ERSPC-RC4.

Outcome measurements and statistical analysis

Logistic regression models were constructed. The areas under the curve (AUCs) of the original ERSPC-RCs and MRI-ERSPC-RCs (including PI-RADS and age) for any- and high-grade PCa were compared. Decision curve analysis was performed to assess the clinical utility of the MRI-ERSPC-RCs.

Results and limitations

MRI-ERSPC-RC3 had a significantly higher AUC for high-grade PCa compared with the ERSPC-RC3: 0.84 (95% confidence interval [CI] 0.81–0.88) versus 0.76 (95% CI 0.71–0.80, p < 0.01). Similarly, MRI-ERSPC-RC4 had a higher AUC for high-grade PCa compared with the ERSPC-RC4: 0.85 (95% CI 0.81–0.89) versus 0.74 (95% CI 0.69–0.79, p < 0.01). Unlike for the MRI-ERSPC-RC3, decision curve analysis showed clear net benefit of the MRI-ERSPC-RC4 at a high-grade PCa risk threshold of ≥5%. Using a ≥10% high-grade PCa risk threshold to biopsy for the MRI-ERSPC-RC4, 36% biopsies are saved, missing low- and high-grade PCa, respectively, in 15% and 4% of men who are not biopsied.

Conclusions

We adjusted the ERSPC-RCs for the prediction of any- and high-grade PCa in 12-core TRUS-Bx ± MRI-TBx. Although the ability of the MRI-ERSPC-RC3 for biopsy-naïve men to avoid biopsies remains questionable, application of the MRI-ERSPC-RC4 in previously biopsied men in our cohort would have avoided 36% of biopsies, missing high-grade PCa in 4% of men who would not have received a biopsy.

Patient summary

We have constructed magnetic resonance imaging-based Rotterdam European Randomized study of Screening for Prostate Cancer (MRI-ERSPC) risk calculators for prostate cancer prediction in transrectal ultrasound-guided biopsy and MRI-targeted biopsy by incorporating age and Prostate Imaging Reporting and Data System score into the original ERSPC risk calculators. The MRI-ERSPC risk calculator for previously biopsied men could be used to avoid one-third of biopsies following MRI.

Introduction

Men with a suspicion of prostate cancer (PCa) based on elevated prostate-specific antigen (PSA) and/or abnormal digital rectal examination (DRE) generally receive a transrectal ultrasound-guided systematic biopsy (TRUS-Bx). Nowadays, multiparametric magnetic resonance imaging (mpMRI) is increasingly being used due to its high negative predictive value for clinically significant PCa of approximately 90% [1], [2], [3]. The European Association of Urology (EAU) PCa guidelines recommend performing prebiopsy mpMRI in men with a suspicion of PCa after previous negative TRUS-Bx [3], [4]. Since not all men with a clinical suspicion who receive mpMRI actually harbor high-grade PCa, a (targeted) biopsy following MRI could be avoided in some of these men using a risk calculator. The Rotterdam European Randomized Study of Screening for Prostate Cancer risk calculators (ERSPC-RCs) are well-validated models that help avoid 20–33% of unnecessary TRUS-Bx [5], [6], [7], [8], [9], [10], [11], [12], [13]. In the present study, we aim to construct MRI-ERSPC-RCs for patient selection for (targeted) biopsy following mpMRI by adding the Prostate Imaging Reporting and Data System (PI-RADS) score and age as parameters to the ERSPC-RC3 (in biopsy-naïve men) and ERSPC-RC4 (in previously biopsied men).

Section snippets

Study population

A total of 1353 consecutive men with a clinical suspicion of PCa (no prior PCa diagnosis), who received mpMRI and subsequent TRUS-Bx and/or targeted biopsy (TBx) between 2012 and 2017, were included in the prospective institutional review board–approved databases of five institutions in Düsseldorf (n = 723), Rotterdam (n = 178), The Hague (n = 210), Amsterdam (n = 160), and Den Bosch (n = 82). Subgroups of the institutional cohorts from Düsseldorf, Rotterdam, and The Hague were reported previously [14],

Patient characteristics

Table 1 shows the patient characteristics of all 1353 men with a clinical suspicion of PCa who received mpMRI and subsequent biopsy between 2012 and 2017 in the five institutions. Median age, PSA, and prostate volume were 66 (interquartile range [IQR] 60–71) yr, 8.7 (IQR 6.1–12.9) ng/ml, and 49.7 (36.0–70.0) ml, respectively. DRE values were missing in 33% (441/1353) men. A total of 82% (1114/1353) men had an overall PI-RADS score of ≥3. TRUS-Bx and MRI-TBx were performed with a median number

Discussion

Risk-based patient selection for TRUS-Bx has been adopted in daily clinical practice, either by clinical judgment or by the use of risk calculators. Using a multivariable risk calculator similar to the original ERSPC-RCs has been shown to reduce the percentage of unnecessary TRUS-Bx by 20–33% in several external validation studies [7], [8], [9], [10], [11], [12], [13]. Nowadays, mpMRI is increasingly performed, especially in men with a sustained suspicion of PCa after previous negative TRUS-Bx

Conclusions

Multivariable risk-based patient selection for biopsy after mpMRI can avoid unnecessary systematic and/or TBx, even after risk stratification before MRI. In the present study, we adjust the multiple externally validated ERSPC-RC-3 (for biopsy-naïve men) and ERSPC-RC-4 (for previously biopsied men) by incorporating the overall PI-RADS score and age. Although the ability of the MRI-ERSPC-RC3 for biopsy-naïve men to avoid biopsies remains questionable, application of the MRI-ERSPC-RC4 in

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