Active surveillance inclusion criteria under scrutiny in magnetic resonance imaging-guided prostate biopsy: a multicenter cohort study

Abstract

Background Although multiparametric magnetic resonance imaging (mpMRI) is recommended for primary risk stratification and follow-up in Active Surveillance (AS), it is not part of common AS inclusion criteria. The objective was to compare AS eligibility by systematic biopsy (SB) and combined MRI-targeted (MRI-TB) and SB within real-world data using current AS guidelines. Methods A retrospective multicenter study was conducted by a German prostate cancer (PCa) working group representing six tertiary referral centers and one outpatient practice. Men with PCa and at least one MRI-visible lesion according to Prostate Imaging Reporting and Data System (PI-RADS) v2 were included. Twenty different AS inclusion criteria of international guidelines were applied to calculate AS eligibility using either a SB or a combined MRI-TB and SB. Reasons for AS exclusion were assessed. Results Of 1941 patients with PCa, per guideline, 583–1112 patients with PCa in both MRI-TB and SB were available for analysis. Using SB, a median of 22.1% (range 6.4–72.4%) were eligible for AS. Using the combined approach, a median of 15% (range 1.7–68.3%) were eligible for AS. Addition of MRI-TB led to a 32.1% reduction of suitable patients. Besides Gleason Score upgrading, the maximum number of positive cores were the most frequent exclusion criterion. Variability in MRI and biopsy protocols potentially limit the results. Conclusions Only a moderate number of patients with PCa can be monitored by AS to defer active treatment using current guidelines for inclusion in a real-world setting. By an additional MRI-TB, this number is markedly reduced. These results underline the need for a contemporary adjustment of AS inclusion criteria.

Contemporary Review of Multimodality Imaging of the Prostate Gland

“…For example, a recent randomized control trial found that mpMRI in combination with TRUS/MRI fusion biopsies detected 12% more clinically significant cancers and 13% less indolent prostate cancers than systematic biopsy and resulted in 28% fewer biopsies being performed overall [41]. Other work has demonstrated the integral role of mpMRI in active surveillance, with MRI-guided targeted biopsies demonstrating clinically significant prostate cancer in 32% of patients previously classified as eligible for active surveillance on systematic biopsy [42]. Lesions selected for biopsy are categorized via the PI-RADS scoring scheme, which has been validated in several studies and demonstrated moderate interobserver variability [26,43,44].…”

Optimising the use of the prostate- specific antigen blood test in asymptomatic men for early prostate cancer detection in primary care: report from a UK clinical consensus

“…Furthermore, it has been suggested that MRI-targeted biopsy may increase overtreatment associated with PSA testing by detecting small amounts of Gleason grade 4 cancer that may have been missed by systematic biopsy and are unlikely to cause harm. 17 – 19 This may lead to ‘upgrading’ of patients who would otherwise be considered low risk (Gleason 6 [3 + 3]), changing their management from active surveillance to radical treatment. 19 …”

Diagnostic performance of microUltrasound at MRI‐guided confirmatory biopsy in patients under active surveillance for low‐risk prostate cancer

“…Its implementation mitigates the burden of overtreatment that up to 20%–50% newly diagnosed men may experience 3 . However, identification and monitoring strategies of patients who may benefit from AS remain challenging 4 …”

“…3 However, identification and monitoring strategies of patients who may benefit from AS remain challenging. 4 AS protocols require a multimodal assessment based on clinical parameters (digital rectal examination [DRE]), laboratory testing (prostate-specific antigen [PSA]), imaging (multiparametric magnetic resonance imaging [mpMRI]), as well as patient willingness to continue surveillance. 5 Since mpMRI introduction in prostate examination, it has been shown to improve the detection of clinically significant prostate cancer (csPCa) and reduce the diagnosis of indolent disease.…”