Office-based Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Real-world Clinical Utility Study.

Background and objective: Advances in for magnetic resonance imaging (MRI)-guided transperineal biopsy (TPBx) techniques have facilitated outpatient prostate biopsies under local anaesthesia to lower postbiopsy infection rates. However, there is debate regarding antibiotic prophylaxis because of concerns regarding antibiotic resistance and interactions. Our objective was to assess the transition from office-based transrectal biopsy to TPBx performed under local anaesthesia without antibiotic prophylaxis despite potential risk factors for infectious complications. Methods: We conducted a prospective assessment of 665 men undergoing office-based MRI-guided TPBx. The primary outcome was the rate of urosepsis or febrile urinary tract infections requiring hospitalisation and/or antibiotics within 2 wk after biopsy. Secondary outcomes included patient-reported procedure tolerability and the prostate cancer detection rate. Key findings and limitations: TPBx using a median of nine cores per patient (range 4-15) detected prostate cancer in 534/665 men (80%). Only four men (0.6%) were hospitalised for suspected postbiopsy infection; no patient experienced urosepsis. The TPBx procedure was well tolerated, with low pain scores (median Visual Analogue Scale score of 2, interquartile range [IQR] 1-3) and positive patient ratings (median rating 1 [no problem], IQR 1-2). Limitations include the single-centre analysis and lack of randomisation for antibiotic prophylaxis. Conclusions and clinical implications: An office-based TPBx strategy under local anaesthesia without antibiotic prophylaxis is well tolerated and has a very low risk of side effects. This approach should be considered as the standard of care. Further studies may determine if a subgroup of predisposed men could benefit from antibiotic prophylaxis. Patient summary: For prostate biopsy the sampling needle can be inserted through the rectum or through the perineum, which is the skin between the rectum and the scrotum. Our study confirms that in everyday clinical practice, prostate biopsy via the perineum can be carried out under local anaesthetic and without routine use of antibiotics because of its lower risk of infection. Patients reported low pain scores and positive ratings for the overall experience.

Interactive training workshop to improve prostate mpMRI knowledge: results from the ESOR Nicholas Gourtsoyiannis teaching fellowship.

PURPOSE: Prostate MRI is established for the investigation of patients presenting with suspected early prostate cancer. Outcomes are dependent on both image quality and interpretation. This study assessed the impact of an educational intervention on participants' theoretical knowledge of the technique. METHODS: Eighty-one clinicians from two centers with varying experience in prostate MRI participated. Baseline knowledge was assessed with 10 written and image-based multiple-choice questions (MCQs) prior to a course including didactic lectures and hands-on interactive workshops on prostate MRI interpretation. Post-course, participants completed a second 10-question MCQ test, matched by format, themes, and difficulty, to assess for any improvement in knowledge and performance. Results were assessed using the Wilcoxon rank sum test, and the Wilcoxon signed-rank test for paired data. RESULTS: Thirty-nine participants, including 25/49 (51.0%) and 14/32 (43.8%) at each center completed both assessments, with their results used for subsequent evaluation. Overall, there was a significant improvement from pre- (4.92 ± 2.41) to post-course scores (6.77 ± 1.46), p < 0.001 and at both Copenhagen (5.92 ± 2.25 to 7.36 ± 1.25) and Toronto (3.14 ± 1.51 to 5.71 ± 1.20); p = 0.005 and p = 0.002, respectively. Participants with no prostate MRI experience showed the greatest improvement (3.77 ± 1.97 to 6.18 ± 1.5, p < 0.001), followed by intermediate level (< 500 MRIs reported) experience (6.18 ± 1.99 to 7.46 ± 1.13, p = 0.058), then advanced (> 500 MRIs reported) experience (6.83 ± 2.48 to 7.67 ± 0.82, p = 0.339). CONCLUSIONS: A dedicated prostate MRI teaching course combining didactic lectures and hands-on workshops significantly improved short-term theoretical knowledge of the technique for clinicians with differing levels of experience. CRITICAL RELEVANCE STATEMENT: A dedicated teaching course significantly improved theoretical knowledge of the technique particularly for clinicians with less reporting experience and a lower baseline knowledge. The multiple-choice questions format mapped improved performance and may be considered as part of future MRI certification initiatives. KEY POINTS: • Prostate MRI knowledge is important for image interpretation and optimizing acquisition sequences. • A dedicated teaching course significantly improved theoretical knowledge of the technique. • Improved performance was more apparent in clinicians with less reporting experience and a lower baseline knowledge.

Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol: Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP.

INTRODUCTION: The primary objective of the Danish Prostate Cancer Consortium Study 1 (DPCC-1) is to provide validation for a novel urine-based microRNA biomarker, called uCaP, for a diagnosis of prostate cancer. METHODS AND ANALYSIS: Eligible participants are biopsy naïve men aged ≥18 years with prostate-specific antigen (PSA) levels ≥3 ng/mL, who are referred to prostate MRI due to suspicion of PC at one of the following three major urology/uroradiology centers: Aarhus University Hospital, Herlev & Gentofte University Hospital, or Odense University Hospital, where MRI and targeted biopsy are implemented in clinical use. Exclusion criteria include previous diagnosis of urogenital cancer, contraindication to MRI, gender reassignment treatment or PSA level >20 ng/mL. The participants will be asked to donate a urine sample in connection with their MRI. The study is observational, uses a diagnostic accuracy testing setup and will integrate into the current diagnostic pathway.We will measure the levels of the three microRNAs in the uCaP model (miR-222-3 p, miR-24-3 p and miR-30c-5p) in extracellular vesicle-enriched cell-free urine samples, to assess if uCaP can improve specificity and retain sensitivity for International Society of Urological Pathology Grade Group ≥2 PC, when used as a reflex test to PSA ≥3 ng/mL. We hypothesise that uCaP can improve selection for prostate MRI and reduce the number of unnecessary scans and biopsies. ETHICS AND DISSEMINATION: This study is approved by the Central Denmark Region Committee on Health Research Ethics (reference number: 1-10-72-85-22). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented in scientific meetings. TRIAL REGISTRATION NUMBER: NCT05767307 at clinicaltrials.gov.

Quantification of cross-vendor variation in ADC measurements in vendor-specific prostate MRI-protocols.

PURPOSE: The purpose of this study was to quantify the variability of Apparent Diffusion Coefficient (ADC) and test if there were statistically significant differences in ADC between MRI systems and sequences. METHOD: With a two-chamber cylindrical ADC phantom with fixed ADC values (1,000 and 1,600x10-6 mm2/s) a single-shot (ss) Echo Planar Imaging (EPI), a multi-shot EPI, a reduced field of view DWI (zoom) and a Turbo Spin Echo DWI sequence were tested in six MRI systems from three vendors at 1.5 T and 3 T. Technical parameters were according to Prostate Imaging Reporting and Data System Version 2.1. ADC maps were calculated by vendor specific algorithms. Absolute and relative differences in ADC from the phantom-ADC were calculated and differences between sequences were tested. RESULTS: At 3 T absolute differences from phantom given ADC (∼1,000 and âˆ¼ 1,600x10-6 mm2/s) were -83 - 42x10-6 mm2/s (-8.3%-4.2%) and -48 - 15x10-6 mm2/s (-3%-0.9%), respectively and at 1.5 T absolute differences were -81 - 26x10-6 mm2/s (-2.6%-8.1%) and -74 - 67x10-6 mm2/s (-4.6%-4.2%), respectively. Significant statistical differences in ADC measurements were identified between vendors in all sequences except for ssEPI and zoom at 3 T in the 1,600x10-6 mm2/s phantom chamber. Significant differences were also identified between ADC measurements at 1.5 T and 3 T in some of the sequences and vendors, but not all. CONCLUSION: The variation of ADC between different MRI systems and prostate specific DWI sequences is limited in this phantom study and without apparent clinical relevance. However, prospective multicenter studies of prostate cancer patients are needed for further investigation.

Intense PSMA Uptake in a Vertebral Hemangioma Mimicking a Solitary Bone Metastasis in the Primary Staging of Prostate Cancer via 68Ga-PSMA PET/CT.

A 78-year-old man with newly diagnosed high-risk prostate cancer underwent 68Ga-PSMA PET/CT for primary staging. This showed a single, very intense PSMA uptake in the vertebral body of Th2, without discrete morphological changes on low-dose CT. Thus, the patient was considered oligometastatic and underwent MRI of the spine for stereotactic radiotherapy planning. MRI demonstrated an atypical hemangioma in Th2. A bone algorithm CT scan confirmed the MRI findings. The treatment was changed, and the patient underwent a prostatectomy with no concomitant therapy. At three and six months after the prostatectomy, the patient had an unmeasurable PSA level, confirming the benign etiology of the lesion.

Comparison of PSA density and lesion volume strategies for selecting men with equivocal PI-RADS 3 lesions on bpMRI for biopsies.

PURPOSE: To compare two strategies: Prostate-specific antigen density (PSAd) and lesion volume measurement in ruling out significant prostate cancer (sPCa) in men with equivocal Prostate Imaging Reporting and Data System (PI-RADS) category 3 index lesions on biparametric magnetic resonance imaging. METHODS: In total, 130 men from our database had index lesions with PI-RADS scores of 3. Prostate volume was measured using the ellipsoid method, in accordance with PI-RADS version 2.1 criteria. Index lesion volumes were also measured using the ellipsoidal formula on the diffusion-weighted imaging sequence with the highest b-value and sagittal T2 sequences. RESULTS: Among 130 men with PI-RADS category 3 index lesions, 23 (18%) had sPCa. In total, 6 of the 89 men with PSAd < 0.15 ng/mL2 (7%) had sPCa, whereas 8 of the 49 men with index lesion volumes < 0.5 mL (16%) had sPCa. The difference was statistically significant (McNemar, p < 0.0001). CONCLUSION: The PSAd strategy performed better than the lesion volume strategy in ruling out sPCa in men with equivocal PI-RADS category 3 index lesions.

Can whole-body MRI replace CT in management of metastatic testicular cancer? A prospective, non-inferiority study.

PURPOSE: Concerns of imaging-related radiation exposure in young patients with high survival rates have increased the use of magnetic resonance imaging (MRI) in testicular cancer (TC) stage I. However, computed tomography (CT) is still preferred for metastatic TC. The purpose of this study was to compare whole-body MRI incl. diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) with contrast-enhanced, thoracoabdominal CT in metastatic TC. METHODS: A prospective, non-inferiority study of 84 consecutive patients (median age 33 years) with newly diagnosed metastatic TC (February 2018-January 2021). Patients had both MRI and CT before and after treatment. Anonymised images were reviewed by experienced radiologists. Lesion malignancy was evaluated on a Likert scale (1 benign-4 malignant). Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated on patient and lesion level. The primary outcome was demonstrating non-inferiority regarding sensitivity of MRI compared to CT. The non-inferiority margin was set at 5%. ROC curves and interobserver agreement were calculated. RESULTS: On patient level, MRI had 98% sensitivity and 75% specificity compared to CT. On lesion level within each modality, MRI had 99% sensitivity and 78% specificity, whereas CT had 98% sensitivity and 88% specificity. MRI sensitivity was non-inferior to CT (difference 0.57% (95% CI - 1.4-2.5%)). The interobserver agreement was substantial between CT and MRI. CONCLUSION: MRI with DWIBS was non-inferior to contrast-enhanced CT in detecting metastatic TC disease. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT03436901, finished July 1st 2021.

Early experience in avoiding biopsies for biopsy-naïve men with clinical suspicion of prostate cancer but non-suspicious biparametric magnetic resonance imaging results and prostate-specific antigen density < 0.15 ng/mL2: A 2-year follow-up study.

Background: Only limited data have been published on the diagnostic accuracy of combining biparametric (bp) magnetic resonance imaging (MRI) and prostate-specific antigen density (PSAd) to rule out biopsies. Purpose: The purpose is to assess the 2-year risk of being diagnosed with sPCa following the strategy of avoiding immediate biopsies in men with non-suspicious bp MRIs and a PSAd <0.15 ng/mL2. Material and Methods: Two hundred biopsy-naïve men with clinical suspicion of PCa underwent a pre-biopsy bp MRI from March to July 2019. Of these, 109 men had a Prostate Imaging Reporting and Data System (PI-RADS) score of 1-3 including 77 men with calculated PSAd <0.15 ng/mL2. As a result, no biopsies were performed in these 77 men, who were clinically followed up for at least 2 years and re-examined in case of rising suspicion of sPCa. The remaining 32 men with a calculated PSAd ≥0.15 ng/mL2 underwent systematic biopsies and targeted biopsies of any PI-RADS 3 lesion. Results: One of the 77 men (1.3%) had an sPCa diagnosed within 2 years of follow-up. All men were referred back to their general practitioner within 1 year and 9% (7/77) were re-referred to the urology department during follow-up. Among these men, 43% (3/7) continued to have PSA levels that were above their individual thresholds at confirmatory testing and underwent secondary MRI scans. Conclusions: No biopsies for men with bpMRI results exhibiting maximum PI-RADS 3 and with a PSAd <0.15 ng/mL2 resulted in a 2-year risk of being diagnosed with sPCa of 1.3%.

Outcome of 5-year follow-up in men with negative findings on initial biparametric MRI.

BACKGROUND: We assessed the 5-year risk of being diagnosed with significant prostate cancer following a low-suspicion biparametric magnetic resonance imaging result. METHODS: The study population was derived from a prospective database used to assess the diagnostic accuracy of biparametric magnetic resonance imaging for significant prostate cancer detection in 1020 biopsy-naïve men. Significant prostate cancer was defined as any core with Gleason grade group ≥3 or a maximum cancerous core length greater than 50% of Gleason grade group 2. A secondary definition of significant prostate cancer was also included: any core with prostate cancer Gleason grade group ≥2. Of the 1020 men, 305 had a low-suspicion biparametric magnetic resonance imaging result (Prostate Imaging Reporting and Data System score of 1 or 2) but four men were excluded from follow-up. Thus, the final study population consisted of 301 men, who were clinically followed-up from inclusion (November 2015 to June 2017) until 1 June 2021. FINDINGS: Overall, 1·7% (5/301) of the study population had significant prostate cancer diagnosed within 5 years (median 1480 days, Interquartile Range (1587-1382)) of their low-suspicion result and corresponding set of biopsies. When the secondary definition of significant prostate cancer was applied, this increased to 5% (15/301) of the study population. INTERPRETATION: The 5-year risk of being diagnosed with significant prostate cancer after a prebiopsy low-suspicion prebiopsy biparametric magnetic resonance imaging result was 1·7%.

International Multi-Site Initiative to Develop an MRI-Inclusive Nomogram for Side-Specific Prediction of Extraprostatic Extension of Prostate Cancer.

BACKGROUND: To develop an international, multi-site nomogram for side-specific prediction of extraprostatic extension (EPE) of prostate cancer based on clinical, biopsy, and magnetic resonance imaging- (MRI) derived data. METHODS: Ten institutions from the USA and Europe contributed clinical and side-specific biopsy and MRI variables of consecutive patients who underwent prostatectomy. A logistic regression model was used to develop a nomogram for predicting side-specific EPE on prostatectomy specimens. The performance of the statistical model was evaluated by bootstrap resampling and cross validation and compared with the performance of benchmark models that do not incorporate MRI findings. RESULTS: Data from 840 patients were analyzed; pathologic EPE was found in 320/840 (31.8%). The nomogram model included patient age, prostate-specific antigen density, side-specific biopsy data (i.e., Gleason grade group, percent positive cores, tumor extent), and side-specific MRI features (i.e., presence of a PI-RADSv2 4 or 5 lesion, level of suspicion for EPE, length of capsular contact). The area under the receiver operating characteristic curve of the new, MRI-inclusive model (0.828, 95% confidence limits: 0.805, 0.852) was significantly higher than that of any of the benchmark models (p < 0.001 for all). CONCLUSIONS: In an international, multi-site study, we developed an MRI-inclusive nomogram for the side-specific prediction of EPE of prostate cancer that demonstrated significantly greater accuracy than clinical benchmark models.

Comparison of contrast-enhanced CT, dual-layer detector spectral CT, and whole-body MRI in suspected metastatic breast cancer: a prospective diagnostic accuracy study.

OBJECTIVES: To compare diagnostic accuracy of contrast-enhanced CT, dual-layer detector spectral CT (DL-CT), and whole-body MRI (WB-MRI) for diagnosing metastatic breast cancer. METHODS: One hundred eighty-two biopsy-verified breast cancer patients suspected of metastatic disease prospectively underwent contrast-enhanced DL-CT and WB-MRI. Two radiologists read the CT examinations with and without spectral data in consensus with 3-month washout between readings. Two other radiologists read the WB-MRI examinations in consensus. Lymph nodes, visceral lesions, and bone lesions were assessed. Readers were blinded to other test results. Reference standard was histopathology, previous or follow-up imaging, and clinical follow-up. RESULTS: Per-lesion AUC was 0.80, 0.84, and 0.82 (CT, DL-CT, and WB-MRI, respectively). DL-CT showed significantly higher AUC than CT (p = 0.001) and WB-MRI (p = 0.02). Sensitivity and specificity of CT, DL-CT, and WB-MRI were 0.66 and 0.94, 0.75 and 0.95, and 0.65 and 0.98, respectively. DL-CT significantly improved sensitivity compared to CT (p < 0.0001) and WB-MRI (p = 0.002). Per-patient AUC was 0.85, 0.90, and 0.92 (CT, DL-CT, and WB-MRI, respectively). DL-CT and WB-MRI had significantly higher AUC than CT (p = 0.04 and p = 0.03). DL-CT significantly increased sensitivity compared to CT (0.89 vs. 0.79, p = 0.04). WB-MRI had significantly higher specificity than CT (0.84 vs. 0.96, p = 0.001) and DL-CT (0.87 vs. 0.96, p = 0.02). CONCLUSIONS: DL-CT showed significantly higher per-lesion diagnostic performance and sensitivity than CT and WB-MRI. On a per-patient basis, DL-CT and WB-MRI had equal diagnostic performance superior to CT. KEY POINTS: • Spectral CT has higher diagnostic performance for diagnosing breast cancer metastases compared to conventional CT and whole-body MRI on a per-lesion basis. • Spectral CT and whole-body MRI are superior to conventional CT for diagnosing patients with metastatic breast cancer. • Whole-body MRI is superior to conventional CT and spectral CT for diagnosing bone metastases.

ESUR/ESUI position paper: developing artificial intelligence for precision diagnosis of prostate cancer using magnetic resonance imaging.

Artificial intelligence developments are essential to the successful deployment of community-wide, MRI-driven prostate cancer diagnosis. AI systems should ensure that the main benefits of biopsy avoidance are delivered while maintaining consistent high specificities, at a range of disease prevalences. Since all current artificial intelligence / computer-aided detection systems for prostate cancer detection are experimental, multiple developmental efforts are still needed to bring the vision to fruition. Initial work needs to focus on developing systems as diagnostic supporting aids so their results can be integrated into the radiologists' workflow including gland and target outlining tasks for fusion biopsies. Developing AI systems as clinical decision-making tools will require greater efforts. The latter encompass larger multicentric, multivendor datasets where the different needs of patients stratified by diagnostic settings, disease prevalence, patient preference, and clinical setting are considered. AI-based, robust, standard operating procedures will increase the confidence of patients and payers, thus enabling the wider adoption of the MRI-directed approach for prostate cancer diagnosis. KEY POINTS: • AI systems need to ensure that the benefits of biopsy avoidance are delivered with consistent high specificities, at a range of disease prevalence. • Initial work has focused on developing systems as diagnostic supporting aids for outlining tasks, so they can be integrated into the radiologists' workflow to support MRI-directed biopsies. • Decision support tools require a larger body of work including multicentric, multivendor studies where the clinical needs, disease prevalence, patient preferences, and clinical setting are additionally defined.

For men enrolled in active surveillance, pre-biopsy biparametric magnetic resonance imaging significantly reduces the risk of reclassification and disease progression after 1 year.

AIMS: To assess the level of disease progression at confirmatory staging biopsies after 1 year of active surveillance (AS) and compare the detection rate of significant prostate cancers (PCas) in patients who underwent pre-biopsy biparametric magnetic resonance imaging (bpMRI) before the first set of diagnostic transrectal ultrasonography-guided biopsies (TRUS-bx) with the detection rate in patients who did not undergo pre-biopsy bpMRI. MATERIALS AND METHODS: Comparison of two patient groups enrolled in AS. Patients in Group A (n = 127) underwent pre-biopsy bpMRI followed by TRUS-bx ± targeted biopsies. Patients in Group B (n = 127) were enrolled in AS based on biopsy results from TRUS-bx only. RESULTS: Overall, 6% of the patients in Group A and 20% of the patients in Group B had an upgrade in Gleason grade from insignificant to significant PCa at confirmatory staging biopsies (odds ratio [OR], 3.5; p = .002; 95% confidence interval [CI], 1.6-7.9). CONCLUSIONS: Patients who underwent pre-biopsy bpMRI before the first set of diagnostic biopsies had a reduced risk of reclassification and disease progression after 1 year of AS. Thus, pre-biopsy bpMRI improves the selection of men who should be enrolled in AS.

ESUR/ESUI consensus statements on multi-parametric MRI for the detection of clinically significant prostate cancer: quality requirements for image acquisition, interpretation and radiologists' training.

OBJECTIVES: This study aims to define consensus-based criteria for acquiring and reporting prostate MRI and establishing prerequisites for image quality. METHODS: A total of 44 leading urologists and urogenital radiologists who are experts in prostate cancer imaging from the European Society of Urogenital Radiology (ESUR) and EAU Section of Urologic Imaging (ESUI) participated in a Delphi consensus process. Panellists completed two rounds of questionnaires with 55 items under three headings: image quality assessment, interpretation and reporting, and radiologists' experience plus training centres. Of 55 questions, 31 were rated for agreement on a 9-point scale, and 24 were multiple-choice or open. For agreement items, there was consensus agreement with an agreement ≥ 70% (score 7-9) and disagreement of ≤ 15% of the panellists. For the other questions, a consensus was considered with ≥ 50% of votes. RESULTS: Twenty-four out of 31 of agreement items and 11/16 of other questions reached consensus. Agreement statements were (1) reporting of image quality should be performed and implemented into clinical practice; (2) for interpretation performance, radiologists should use self-performance tests with histopathology feedback, compare their interpretation with expert-reading and use external performance assessments; and (3) radiologists must attend theoretical and hands-on courses before interpreting prostate MRI. Limitations are that the results are expert opinions and not based on systematic reviews or meta-analyses. There was no consensus on outcomes statements of prostate MRI assessment as quality marker. CONCLUSIONS: An ESUR and ESUI expert panel showed high agreement (74%) on issues improving prostate MRI quality. Checking and reporting of image quality are mandatory. Prostate radiologists should attend theoretical and hands-on courses, followed by supervised education, and must perform regular performance assessments. KEY POINTS: • Multi-parametric MRI in the diagnostic pathway of prostate cancer has a well-established upfront role in the recently updated European Association of Urology guideline and American Urological Association recommendations. • Suboptimal image acquisition and reporting at an individual level will result in clinicians losing confidence in the technique and returning to the (non-MRI) systematic biopsy pathway. Therefore, it is crucial to establish quality criteria for the acquisition and reporting of mpMRI. • To ensure high-quality prostate MRI, experts consider checking and reporting of image quality mandatory. Prostate radiologists must attend theoretical and hands-on courses, followed by supervised education, and must perform regular self- and external performance assessments.

Comparison of bi- and multiparametric magnetic resonance imaging to select men for active surveillance.

BACKGROUND: Active surveillance of men with prostate cancer relies on accurate risk assessments because it aims to avoid or delay invasive therapies and reduce overtreatment. PURPOSE: To compare the diagnostic performance of pre-biopsy biparametric magnetic resonance imaging (MRI) with confirmatory multiparametric MRI in selecting men for active surveillance. MATERIAL AND METHODS: The study population included biopsy-naïve men with clinical suspicion of prostate cancer undergoing biparametric MRI followed by combined (standard plus MRI targeted) biopsies. Men diagnosed with prostate cancer who were subsequently enrolled in active surveillance and underwent a confirmatory multiparametric MRI within three months of diagnosis were included in the study. Discrepancies between the pre-biopsy biparametric MRI and the confirmatory multiparametric MRI were assessed. RESULTS: Overall, 101 men (median age = 64 years; median prostate-specific-antigen level = 6.3 ng/mL) were included. Nine patients were re-biopsied after multiparametric MRI for the following reasons: suspicion of targeting error (three patients); a new suspicious lesion detected by multiparametric MRI (five patients); and an increase in tumor volume (one patient) compared with biparametric MRI. Confirmatory biopsies showed a Gleason grade group (GG) upgrade of ≥2 in 4/6 patients with suspicion of more advanced disease (missed suspicious lesion, increase in tumor volume) on multiparametric MRI. However, although multiparametric MRI subsequently detected a GG ≥ 2 prostate cancer lesion missed by biparametric MRI in 4% (4/101) of included men, the difference did not reach statistical significance (McNemar, P = 0.133). CONCLUSION: Biparametric MRI could be used to select men eligible for active surveillance and a confirmatory multiparametric MRI performed shortly after inclusion seems unnecessary.

Prebiopsy Biparametric Magnetic Resonance Imaging Combined with Prostate-specific Antigen Density in Detecting and Ruling out Gleason 7-10 Prostate Cancer in Biopsy-naïve Men.

BACKGROUND: Multiparametric magnetic resonance imaging (MRI) combined with prostate-specific-antigen density (PSAd) enhances the detection of significant prostate cancer (sPCa). However, it is unclear whether simple biparametric (bp) MRI, which reduces scan sequences, time, and cost, may be an equally effective noninvasive tool for detecting and ruling out sPCa and avoiding biopsies in biopsy-naïve men. OBJECTIVE: To assess the diagnostic accuracy, predictive values, and best biopsy strategy combining bpMRI and PSAd in detecting and ruling out sPCa (Gleason score ≥7). DESIGN, SETTING, AND PARTICIPANTS: Assessment of 808 biopsy-naïve men with clinical suspicion of localised PCa (prostate-specific antigen <20ng/ml, rectal examination

The primacy of multiparametric MRI in men with suspected prostate cancer.

BACKGROUND: Multiparametric MRI (mpMRI) became recognised in investigating those with suspected prostate cancer between 2010 and 2012; in the USA, the preventative task force moratorium on PSA screening was a strong catalyst. In a few short years, it has been adopted into daily urological and oncological practice. The pace of clinical uptake, born along by countless papers proclaiming high accuracy in detecting clinically significant prostate cancer, has sparked much debate about the timing of mpMRI within the traditional biopsy-driven clinical pathways. There are strongly held opposing views on using mpMRI as a triage test regarding the need for biopsy and/or guiding the biopsy pattern. OBJECTIVE: To review the evidence base and present a position paper on the role of mpMRI in the diagnosis and management of prostate cancer. METHODS: A subgroup of experts from the ESUR Prostate MRI Working Group conducted literature review and face to face and electronic exchanges to draw up a position statement. RESULTS: This paper considers diagnostic strategies for clinically significant prostate cancer; current national and international guidance; the impact of pre-biopsy mpMRI in detection of clinically significant and clinically insignificant neoplasms; the impact of pre-biopsy mpMRI on biopsy strategies and targeting; the notion of mpMRI within a wider risk evaluation on a patient by patient basis; the problems that beset mpMRI including inter-observer variability. CONCLUSIONS: The paper concludes with a set of suggestions for using mpMRI to influence who to biopsy and who not to biopsy at diagnosis. KEY POINTS: • Adopt mpMRI as the first, and primary, investigation in the workup of men with suspected prostate cancer. • PI-RADS assessment categories 1 and 2 have a high negative predictive value in excluding significant disease, and systematic biopsy may be postponed, especially in men with low-risk of disease following additional risk stratification. • PI-RADS assessment category lesions 4 and 5 should be targeted; PI-RADS assessment category lesion 3 may be biopsied as a target, as part of systematic biopsies or may be observed depending on risk stratification.

A predictive model based on biparametric magnetic resonance imaging and clinical parameters for improved risk assessment and selection of biopsy-naïve men for prostate biopsies.

BACKGROUND: Prostate cancer risk prediction models and multiparametric magnetic resonance imaging (mpMRI) are used for individualised pre-biopsy risk assessment. However, biparametric MRI (bpMRI) has emerged as a simpler, more rapid MRI approach (fewer scan sequences, no intravenous contrast-media) to reduce costs and facilitate a more widespread clinical implementation. It is unknown how bpMRI and risk models perform conjointly. Therefore, the objective was to develop a predictive model for significant prostate cancer (sPCa) in biopsy-naive men based on bpMRI findings and clinical parameters. METHODS: Eight hundred and seventy-six biopsy-naive men with clinical suspicion of prostate cancer (prostate-specific antigen, <50 ng/mL; tumour stage,

68Ga-PSMA-PET/CT in comparison with 18F-fluoride-PET/CT and whole-body MRI for the detection of bone metastases in patients with prostate cancer: a prospective diagnostic accuracy study.

OBJECTIVES: To determine the diagnostic accuracy of 68gallium prostate-specific membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in comparison with 18F-fluoride-based PET/CT (NaF-PET/CT) and whole-body magnetic resonance imaging (WB-MRI) for the detection of bone metastases in patients with prostate cancer. METHODS: Sixty patients with prostate cancer were included in the period May 2016 to June 2017. The participants underwent three scans (index tests) within 30 days: a NaF-PET/CT, a WB-MRI and a PSMA-PET/CT. Experienced specialists assessed the scans. In the absence of a histological reference standard, the final diagnosis was determined as a panel diagnosis. Measures of the diagnostic performances of the index tests were calculated from patient-based dichotomous outcomes (0 or ≥ 1 bone metastasis) and pairwise compared (McNemar test). For each index test, the agreement with the final diagnosis with regard to the number of bone metastases detected (0, 1-5, > 5) and the inter-reader agreement was calculated (kappa coefficients). RESULTS: Fifty-five patients constituted the final study population; 20 patients (36%) were classified as having bone metastatic disease as their final diagnosis. The patient-based diagnostic performances were (sensitivity, specificity, overall accuracy) PSMA-PET/CT (100%, 100%, 100%), NaF-PET/CT (95%, 97%, 96%) and WB-MRI (80%, 83%, 82%). The overall accuracy of PSMA-PET/CT was significantly more favourable compared to WB-MRI (p = 0.004), but not to NaF-PET/CT (p = 0.48). PSMA-PET/CT classified the number of bone metastases reliably compared to the final diagnosis (kappa coefficient 0.97) and with an "almost perfect" inter-reader agreement (kappa coefficient 0.93). CONCLUSIONS: The overall accuracy of PSMA-PET/CT was significantly more advantageous compared to WB-MRI, but not to NaF-PET/CT. KEY POINTS: • PSMA-PET/CT assessed the presence of bone metastases correctly in all 55 patients • PSMA-PET/CT was more advantageous compared to WB-MRI • No difference was found between PSMA-PET/CT and NaF-PET/CT.