A systematic literature review of magnetic resonance imaging (MRI)–targeted prostate biopsy demonstrates poor adherence to the Standards for the Reporting of Diagnostic Accuracy (STARD) recommendations for the full and transparent reporting of diagnostic studies.
Objective
To define and recommend Standards of Reporting for MRI-targeted Biopsy Studies (START).
Design, setting, and participants
Each member of a panel of 23 experts in urology, radiology, histopathology, and methodology used the RAND/UCLA appropriateness methodology to score a 258-statement premeeting questionnaire. The collated responses were presented at a face-to-face meeting, and each statement was rescored after group discussion.
Outcome measurements and statistical analysis
Measures of agreement and consensus were calculated for each statement. The most important statements, based on group median score, the degree of group consensus, and the content of the group discussion, were used to create a checklist of reporting criteria (the START checklist).
Results and limitations
The strongest recommendations were to report histologic results of standard and targeted cores separately using Gleason score and maximum cancer core length. A table comparing detection rates of clinically significant and clinically insignificant disease by targeted and standard approaches should also be used. It was recommended to report the recruitment criteria for MRI-targeted biopsy, prior biopsy status of the population, a brief description of the MRI sequences, MRI reporting method, radiologist experience, and image registration technique. There was uncertainty about which histologic criteria constitute clinically significant cancer when the prostate is sampled using MRI-targeted biopsy, and it was agreed that a new definition of clinical significance in this setting needed to be derived in future studies.
Conclusions
Use of the START checklist would improve the quality of reporting in MRI-targeted biopsy studies and facilitate a comparison between standard and MRI-targeted approaches.
Introduction
There is growing interest in the use of prostate magnetic resonance imaging (MRI) to determine who should be offered prostate biopsy and how those biopsies should be taken. The aim of using MRI to refine the biopsy strategy is to maximise the detection of clinically significant prostate cancer (PCa) while reducing the burden of biopsy for men and the health care system. A systematic review to compare the accuracy of an MRI-targeted biopsy approach with standard transrectal biopsy for the detection of clinically significant disease has recently been published [1]. In 2003, the Standards for the Reporting of Diagnostic Accuracy (STARD) initiative published recommendations for the full and transparent reporting of diagnostic studies, including the use of a flowchart describing outcomes for each study participant and a checklist of items to be described [2]. The majority of studies of MRI-targeted biopsy in the systematic review did not conform well to these standards. In particular, most studies did not compare the detection of clinically significant PCa between MRI-targeted and standard approaches.
Thus, a consensus meeting composed primarily of urologists and radiologists with expertise in the field of MRI-targeted biopsy was set up to establish Standards of Reporting for MRI-targeted Biopsy Studies (START). Recommendations arising from a consensus meeting among experts in a field are useful when there is a lack of direct evidence from high-quality studies or conflicting data in the published literature [3]. The key features of the consensus methodology were two rounds of scoring of agreement with explicit statements; controlled feedback, where the first-round scores were fed back to the group prior to discussion and rescoring; presentation of statistical measures of the group's agreement and a measure of the consensus within the group for each statement; and anonymised scoring, so that more vocal panel members did not dominate the outcome.
The objective of this paper is to define the standards required for the reporting of studies of MRI-targeted prostate biopsies to improve the quality of the published research in this field and allow comparison, data synthesis, and meta-analysis of future reports.
Section snippets
Study design
Formal consensus methodology adapted from the RAND Corporation/University of California, Los Angeles (RAND/UCLA) appropriateness method was used [4]. In round 1, a list of statements related to the reporting of MRI-targeted biopsy studies was generated (C.M., V.K.) and sent to all panel members for additions and amendments. Two hundred fifty-eight statements were agreed upon. Each panellist then scored his or her agreement with each statement on a scale of 1–9, where 1 represented strong
Results
During the first round, 114 of 258 (44%) statements were scored with consensus. After discussion at the meeting, 120 of 234 statements (51%) were scored with consensus: 117 statements were scored with agreement and consensus, 3 statements with disagreement and consensus, and 114 statements with uncertainty (Table 1).
Summary of findings
The START checklist (Table 3) specifies key information that should be included in reports of studies evaluating MRI-targeted biopsies of the prostate.
Clinical and research implications
The ideal biopsy strategy for identifying PCa would successfully identify men with clinically significant cancer while overlooking men with clinically insignificant cancer and do so in a manner that minimises biopsy number and burden. MRI-targeted biopsy is a promising biopsy technique that may offer these advantages over standard TRUS-guided
Conclusions
Reporting of MRI-targeted biopsy according to the START checklist, as described here, would improve the quality of reporting and facilitate a comparison between standard biopsy and MRI-targeted approaches. Collation of data from studies fulfilling the START criteria may more easily allow the evaluation of MRI-targeted biopsy as a diagnostic strategy for the detection of clinically significant cancer.
2024, Urologic Oncology: Seminars and Original Investigations
To determine (i) whether urologist seniority and experience are associated with prostate cancer (CaP) and clinically significant CaP (csCaP) detection rates using magnetic resonance imaging/ultrasound (MRI/US) fusion-guided targeted biopsies, taking multiparametric magnetic resonance imaging (mpMRI) as the reference standard, and (ii) if cancer detection rates (CDR) differ across regions of the prostate using Dickinson's 27-sector map, regardless of seniority.
We retrospectively reviewed a consecutive series of patients with suspicion of prostate cancer who underwent targeted and systematic biopsies at 1 center by 1 of 7 urologists (2 seniors and 5 juniors) between January 1, 2016 and December 31, 2021, following positive mpMRI.
The cohort comprised 403 patients (454 lesions) aged 67.7±6.8. The combined (junior and senior) CDR was 57% for CaP and 28% for csCaP. There were no differences in CDR between junior and senior urologists for CaP (58% vs. 55%, P = 0.538) or csCaP (29% vs. 26%, P = 0.58). A general trend was observed for the learning curve, which indicated increasing CDR with urologist experience. Across the 27 sectors, combined CDR ranged between 39% and 99% for CaP and 1% to 67% for csCaP. When grouping anterior vs. posterior sectors, there were no differences in combined CDR of CaP (64% vs. 67%, P = 0.48) and csCaP (31% vs. 38%, P = 0.19)
Urologist seniority is not associated with CDR, urologist experience tends to improve cancer detection, and CDR does not differ between the anterior and posterior regions of the prostate.
To report an initial experience with a novel, “fully” transperineal (TP) prostate fusion biopsy using an unconstrained ultrasound transducer placed on the perineal skin to guide biopsy needles inserted via a TP approach.
Conventional TP prostate biopsies for detection of prostate cancer have been performed with transrectal ultrasound, requiring specialized hardware, imposing limitations on needle trajectory, and contributing to patient discomfort. Seventy-six patients with known or suspected prostate cancer underwent 78 TP biopsy sessions in an academic center between June 2018 and April 2022 and were included in this study. These patients underwent TP prostate fusion biopsy using a grid or freehand device with transrectal ultrasound as well as TP prostate fusion biopsy using TP ultrasound in the same session. Per-session and per-lesion cancer detection rates were compared for conventional and fully TP biopsies using Fisher exact and McNemar’s tests.
After a refinement period in 30 patients, 92 MRI-visible prostate lesions were sampled in 46 subsequent patients, along with repeat biopsies in 2 of the 30 patients from the refinement period. Grade group ≥2 cancer was diagnosed in 24/92 lesions (26%) on conventional TP biopsy (17 lesions with grid, 7 with freehand device), and in 25/92 lesions (27%) on fully TP biopsy (P = 1.00), with a 73/92 (79%) rate of agreement for grade group ≥2 cancer between the two methods.
Fully TP biopsy is feasible and may detect prostate cancer with detection rates comparable to conventional TP biopsy.
To examine the extent to which the urologist performing biopsy contributes to variation in prostate cancer detection during fusion-guided prostate biopsy.
All men in the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry who underwent fusion biopsy at Michigan Medicine from August 2017 to March 2019 were included. The primary outcomes were clinically significant cancer detection rate (defined as Gleason Grade ≥2) in targeted cores and clinically significant cancer detection on targeted cores stratified by PI-RADS score. Bivariate and multivariable logistic regression analyses were performed.
A total of 1133 fusion biopsies performed by 5 providers were included. When adjusting for patient age, PSA, race, family history, prostate volume, clinical stage, and PI-RADS score, there was no significant difference in targeted clinically significant cancer detection rates across providers (range = 38.5%-46.9%, adjusted P-value = .575). Clinically significant cancer detection rates ranged from 11.1% to 16.7% in PI-RADS 3 (unadjusted P = .838), from 24.6% to 43.4% in PI-RADS 4 (adjusted P = .003), and from 69.4% to 78.8% in PI-RADS 5 (adjusted P = .766) lesions.
There was a statistically significant difference in clinically significant prostate cancer detection in PI-RADS 4 lesions across providers. These findings suggest that even among experienced providers, variation at the urologist level may contribute to differences in clinically significant cancer detection rates within PI-RADS 4 lesions. However, the relative impact of biopsy technique, radiologist interpretation, and MR acquisition protocol requires further study.
To compare the correlation of Gleason score (GS) and ISUP grade determined by prostate biopsies (PBx) and radical prostatectomy (RP) specimens according to the biopsy technique: ultrasound randomised (RBx) vs. MRI/ultrasound fusion targeted (TBx).
Between March 2013 and June 2018, we retrospectively included patients who underwent RP for prostate cancer (PCa) histopathologically proven by RBx and/or TBx. All patients had a prebiopsy MRI by a single radiologist (using PI-RADS score), then transrectal RBx (12cores, blinded to MRI lesions) and TBx (2-4 cores/target) with elastic MRI/ultrasound fusion (UroStation™, Koelis, Grenoble, France). Histological findings were compared: PBx vs. RP.
One hundred and four patients underwent RP after RBx and/or TBx. ISUP concordance rate was better with the association RBx + TBx 49% (51/104) vs. 43.3% with TBx (P = 0.07) and 43.3% with RBx (P = 0.13). With RBx, 50% of the patients were downgraded (52/104) against 42.3% (44/104) with TBx (P = 0.088). The association RBx + TBx significantly decreased the rate of downgrading of the ISUP score compared to the ISUP score of RP 35.6% (37/104) vs. RBx (50%, P = 0.0001) and vs. TBx (42.3%, P = 0.016).
In half of cases, the ISUP score was underestimated in RBx compared to RP specimens. Adding TBx to RBx significantly reduced downgrading. The combination of both biopsy techniques appeared to be the best protocol to get closer to ISUP score and GS of the RP specimens.
C.
Comparer la corrélation entre le score de Gleason (SG) et le grade ISUP déterminés par les biopsies prostatiques (BP) et les pièces de prostatectomie radicale (PR) selon la technique de biopsie : biopsies systématisées écho-guidées (BPs) et biopsies ciblées par fusion d’image écho-IRM (BPc).
Entre mars 2013 et juin 2018, nous avons inclus rétrospectivement tous les hommes ayant eu une PR pour cancer de la prostate (CaP) diagnostiqué par BPs et/ou BPc. Tous les patients avaient une IRM pré-biopsique (interprétée par un seul radiologue utilisant le score PI-RADS), puis des biopsies prostatiques transrectales systématiques BPs (12 biopsies) - en aveugle de la cible IRM–puis des biopsies prostatiques ciblées BPc (2-4 biopsies/cible) avec fusion élastique écho-IRM (UroStation™, Koelis, Grenoble, France). Les résultats histologiques ont été comparés: PR vs BP.
Cent quatre patients ont eu une PR après BPs et/ou BPc. Le taux de concordance ISUP était meilleur avec l’association BPs + BPc 49% (51/104) contre 43,3% avec BPc (p = 0,07) et 43,3% avec BPs (p = 0,13). Avec les BPs, 50% des patients avaient un score ISUP sous-estimé (52/104) contre 42,3% (44/104) avec les BPc (p = 0,088). L’association BPs + BPc diminuait significativement le taux de sous-estimation du score ISUP par rapport à celui des PR avec 35,6% (37/104) vs BPs (50%; p = 0,0001) et vs BPc (42,3%; p = 0,016).
Les biopsies systématiques sous-estimaient le score ISUP dans la moitié des cas. L’ajout de des BPc aux BPs diminuait significativement la sous-estimation. La combinaison des deux techniques de biopsies est apparue comme le meilleur protocole pour se rapprocher du score ISUP et du SG de celui des pièces de PR.
