Performance of multiparametric MRI in men at risk of prostate cancer before the first biopsy: a paired validating cohort study using template prostate mapping biopsies as the reference standard

Abstract

Background Multi-parametric MRI (mp-MRI) has the potential to serve as a non-invasive triage test for men at risk of prostate cancer. Our objective was to determine the performance characteristics of multi-parametric MRI (mpMRI) in men at risk prior to first biopsy using 5mm template prostate mapping (TPM) as the reference standard. Methods One hundred and twenty nine consecutive men with clinical suspicion of prostate cancer that had no prior biopsy, underwent mpMRI (T1/T2-weighted, diffusion-weighting, dynamic-contrast enhancement) followed by TPM. The primary analysis used: a) radiological scores of suspicion of ≥3 attributed from a 5-point ordinal scale, b) a target condition on TPM of any Gleason pattern ≥4 and/or a maximum cancer core length of ≥4mm and c) two sectors of analysis per prostate (right and left prostate halves). Secondary analyses evaluated the impact of: a) changing the mpMRI score threshold to ≥4 and b) varying the target definition for clinical significance. Results 141/258 (55%) sectors of analysis showed “Any cancer”; 77/258 (30%) had the target histological condition for the purpose of deriving the primary outcome. Median (with range) for age, PSA, gland volume and number of biopsies taken were 62 years (−41-82), 5.8ng/ml (1.2-20), 40ml (16-137) and 41 cores (20-93). For the primary outcome sensitivity, specificity, positive and negative predictive values and area under the receiver operating curve (with 95% CI) were 94% (88-99%), 23% (17-29%), 34% (28-40%), 89% (79-98%) and 0.72 (0.65-0.79), respectively. Conclusion MpMRI demonstrated encouraging diagnostic performance characteristics in detecting and ruling-out clinically significant prostate cancer in men at risk who were biopsy naive.

Multiparametric magnetic resonance imaging outperforms the Prostate Cancer Prevention Trial risk calculator in predicting clinically significant prostate cancer

“…Conversely, 3T MP-MRI with endorectal coil for the identification of suspicious prostate lesions and subsequent MRI/TRUS fusion-guided prostate biopsy has exhibited high levels of sensitivity and negative predictive values (>90%) in detecting clinically significant disease. 8,18 In the current study, we observed an overall CDR of 64.6% which is comparable to the 54% to 63% range reported in the literature. 11,19,20 We observed an AUC of 0.769 (95% CI, 0.703-0.834) for lesion suspicion level on MP-MRI in predicting high-grade CaP, which is 10 percentage points better than the PCPTHG AUC of 0.676 (95% CI, 0.592-0.751; P 5 .091).…”

“…7 Conversely, it has been demonstrated that magnetic resonance (MR) imaging (MRI) with subsequent MRI/ transrectal ultrasound (MRI/TRUS) fusion-guided biopsy of the prostate has a high level of sensitivity and a high positive predictive value for identifying CaP with a correlation to clinical significance. [8][9][10] In the current study, for the first time to our knowledge, we compared the performance of the PCPTHG and multiparametric-MRI (MP-MRI) in identifying men at risk of high-grade or clinically significant CaP for prostate biopsy.…”

Evidence-based guideline recommendations on multiparametric magnetic resonance imaging in the diagnosis of prostate cancer: A Cancer Care Ontario clinical practice guideline

“…A total of 8663 original studies in English were identified and 15 were analyzed. [2][3][4][6][7][8][23][24][25][26][27][28][29][30][31] The overall quality varied from low to moderate. Fourteen conference abstracts will require followup in future updated versions.…”

“…• Eight eligible studies 2,3,6,7,[23][24][25][26] addressed the first objective. The quality of evidence ranged from poor to moderate.…”

The Use of Magnetic Resonance Imaging in the Prostate Cancer Primary Diagnostic Pathway: Is It Ready for Primetime?

“…Their early experience which enrolled patients up to five years preceding the commencement of PROMIS reported a sensitivity and NPV of 90% and 70% for cancer of any grade [12]. For different definitions of clinically significant disease the ranges of sensitivity and NPV were 94% to 100% and 89% to 100%.…”