Multiparametric MR imaging for detection of clinically significant prostate cancer: a validation cohort study with transperineal template prostate mapping as the reference standard.

PURPOSE: To evaluate the diagnostic performance of multiparametric (MP) magnetic resonance (MR) imaging for prostate cancer detection by using transperineal template prostate mapping (TTPM) biopsies as the reference standard and to determine the potential ability of MP MR imaging to identify clinically significant prostate cancer. MATERIALS AND METHODS: Institutional review board exemption was granted by the local research ethics committee for this retrospective study. Included were 64 men (mean age, 62 years [range, 40-76]; mean prostate-specific antigen, 8.2 ng/mL [8.2 μg/L] [range, 2.1-43 ng/mL]), 51 with biopsy-proved cancer and 13 suspected of having clinically significant cancer that was biopsy negative or without prior biopsy. MP MR imaging included T2-weighted, dynamic contrast-enhanced and diffusion-weighted imaging (1.5 T, pelvic phased-array coil). Three radiologists independently reviewed images and were blinded to results of biopsy. Two-by-two tables were derived by using sectors of analysis of four quadrants, two lobes, and one whole prostate. Primary target definition for clinically significant disease necessary to be present within a sector of analysis on TTPM for that sector to be deemed positive was set at Gleason score of 3+4 or more and/or cancer core length involvement of 4 mm or more. Sensitivity, negative predictive value, and negative likelihood ratio were calculated to determine ability of MP MR imaging to rule out cancer. Specificity, positive predictive value, positive likelihood ratio, accuracy (overall fraction correct), and area under receiver operating characteristic curves were also calculated. RESULTS: Twenty-eight percent (71 of 256) of sectors had clinically significant cancer by primary endpoint definition. For primary endpoint definition (≥ 4 mm and/or Gleason score ≥ 3+4), sensitivity, negative predictive value, and negative likelihood ratios were 58%-73%, 84%-89%, and 0.3-0.5, respectively. Specificity, positive predictive value, and positive likelihood ratios were 71%-84%, 49%-63%, and 2.-3.44, respectively. Area under the curve values were 0.73-0.84. CONCLUSION: Results of this study indicate that MP MR imaging has a high negative predictive value to rule out clinically significant prostate cancer and may potentially have clinical use in diagnostic pathways of men at risk

Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study

BACKGROUND: Multiparametric MRI of the prostate followed by targeted biopsy is recommended for patients at risk of prostate cancer. However, multiparametric ultrasound is more readily available than multiparametric MRI. Data from paired-cohort validation studies and randomised, controlled trials support the use of multiparametric MRI, whereas the evidence for individual ultrasound methods and multiparametric ultrasound is only derived from case series. We aimed to establish the overall agreement between multiparametric ultrasound and multiparametric MRI to diagnose clinically significant prostate cancer. METHODS: We conducted a prospective, multicentre, paired-cohort, confirmatory study in seven hospitals in the UK. Patients at risk of prostate cancer, aged 18 years or older, with an elevated prostate-specific antigen concentration or abnormal findings on digital rectal examination underwent both multiparametric ultrasound and multiparametric MRI. Multiparametric ultrasound consisted of B-mode, colour Doppler, real-time elastography, and contrast-enhanced ultrasound. Multiparametric MRI included high-resolution T2-weighted images, diffusion-weighted imaging (dedicated high B 1400 s/mm2 or 2000 s/mm2 and apparent diffusion coefficient map), and dynamic contrast-enhanced axial T1-weighted images. Patients with positive findings on multiparametric ultrasound or multiparametric MRI underwent targeted biopsies but were masked to their test results. If both tests yielded positive findings, the order of targeting at biopsy was randomly assigned (1:1) using stratified (according to centre only) block randomisation with randomly varying block sizes. The co-primary endpoints were the proportion of positive lesions on, and agreement between, multiparametric MRI and multiparametric ultrasound in identifying suspicious lesions (Likert score of ≥3), and detection of clinically significant cancer (defined as a Gleason score of ≥4 + 3 in any area or a maximum cancer core length of ≥6 mm of any grade [PROMIS definition 1]) in those patients who underwent a biopsy. Adverse events were defined according to Good Clinical Practice and trial regulatory guidelines. The trial is registered on ISRCTN, 38541912, and ClinicalTrials.gov, NCT02712684, with recruitment and follow-up completed. FINDINGS: Between March 15, 2016, and Nov 7, 2019, 370 eligible patients were enrolled; 306 patients completed both multiparametric ultrasound and multiparametric MRI and 257 underwent a prostate biopsy. Multiparametric ultrasound was positive in 272 (89% [95% CI 85-92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73-82]; difference 11·1% [95% CI 5·1-17·1]). Positive test agreement was 73·2% (95% CI 67·9-78·1; κ=0·06 [95% CI -0·56 to 0·17]). Any cancer was detected in 133 (52% [95% CI 45·5-58]) of 257 patients, with 83 (32% [26-38]) of 257 being clinically significant by PROMIS definition 1. Each test alone would result in multiparametric ultrasound detecting PROMIS definition 1 cancer in 66 (26% [95% CI 21-32]) of 257 patients who had biopsies and multiparametric MRI detecting it in 77 (30% [24-36]; difference -4·3% [95% CI -8·3% to -0·3]). Combining both tests detected 83 (32% [95% CI 27-38]) of 257 clinically significant cancers as per PROMIS definition 1; of these 83 cancers, six (7% [95% CI 3-15]) were detected exclusively with multiparametric ultrasound, and 17 (20% [12-31]) were exclusively detected by multiparametric MRI (agreement 91·1% [95% CI 86·9-94·2]; κ=0·78 [95% CI 0·69-0·86]). No serious adverse events were related to trial activity. INTERPRETATION: Multiparametric ultrasound detected 4·3% fewer clinically significant prostate cancers than multiparametric MRI, but it would lead to 11·1% more patients being referred for a biopsy. Multiparametric ultrasound could be an alternative to multiparametric MRI as a first test for patients at risk of prostate cancer, particularly if multiparametric MRI cannot be carried out. Both imaging tests missed clinically significant cancers detected by the other, so the use of both would increase the detection of clinically significant prostate cancers compared with using each test alone. FUNDING: The Jon Moulton Charity Trust, Prostate Cancer UK, and UCLH Charity and Barts Charity

Introduction of an enhanced recovery protocol for radical cystectomy

Objective: To describe and assess an enhanced recovery protocol (ERP) for the peri-operative management of patients undergoing radical cystectomy (RC), which was started at our institution on 1 October 2005, as RC is associated with increased morbidity and longer inpatient stays than other major urological procedures. Patients and methods: An ERP was introduced in our institution that focused on reduced bowel preparation, and standardized feeding and analgesic regimens. In all, 112 consecutive patients were compared, i.e. 56 before implementing the ERP and 56 since introducing the ERP. The primary outcome measures were duration of total inpatient stay and interval from surgery to discharge, and the morbidity and mortality. Data were analysed retrospectively from cancer network and hospital records. Results: The demographics of the two groups showed no significant difference in age, gender distribution, American Society of Anesthesiologists grade, or type of urinary diversion. Re-admission, mortality and morbidity rates showed no statistically significant difference between the groups. The median (interquartile range) duration of hospital stay was 17 (15-23) days in the no-ERP group, and 13 (11-17) days in the ERP group (significantly different, P < 0.001, Wilcoxon rank-sum test). The median duration of recovery after RC was 15 (13-21) days in the no-ERP group and 12 (10-15) days in the ERP group (significantly different, P = 0.001, Wilcoxon rank-sum test). Conclusion: The introduction of an ERP was associated with significantly reduced hospital stay, with no deleterious effect on morbidity or mortality.4 page(s

A Three-centre experience of orthotopic neobladder reconstruction after radical cystectomy : revisiting the initial experience, and results in 104 patients

OBJECTIVE: To assess, in a retrospective three-centre series, a second analysis of the initial experience and results of patients undergoing radical cystectomy (RC) and orthotopic neobladder reconstruction (ONR) after an additional 4 years of follow-up. PATIENTS AND METHODS: The medical records of 104 suitable consecutive patients undergoing RC and ONR between June 1994 and April 2003 were reviewed retrospectively. The complications, mortality, continence and cancer control rates were all recorded. RESULTS: The median (range) follow-up was 88 (52-156) months; 90 patients had reconstruction with a 'Studer' neobladder, 12 with a Hautmann W pouch and 2 with a 'T pouch' ileal neobladder. There were 24 early complications, and one death after surgery. There were 32 late complications. The daytime continence rate was 98% and the nocturnal continence rate was 76%. Ten patients required intermittent self-catheterization (ISC). In all, 30 patients had local and/or distant recurrences, all of whom died. Seven patients died from other causes. CONCLUSIONS: ONR provides excellent long-term continence rates and both acceptable complication and mortality rates. Suitable patients undergoing RC should be offered ONR.4 page(s

What Burden of Prostate Cancer Can Radiologists Rule Out on Multiparametric Magnetic Resonance Imaging? A Sensitivity Analysis Based on Varying the Target Condition in Template Prostate Mapping Biopsies.

OBJECTIVE: To evaluate the minimum disease burden of prostate cancer at which multiparametric magnetic resonance imaging (MRI) optimally performs. METHODS: Between 2006 and 2008, 64 men underwent multiparametric MRI imaging (index test) followed by template prostate mapping biopsy (reference test). Three radiologists independently reported each quadrant of every prostate on a scale of 1 to 5: highly likely benign, likely benign, equivocal, likely malignant, highly likely malignant (≥3 or ≥4 was considered positive). There were 256 prostate sectors; bootstrapping adjustment was used to account for nonindependence. The target condition indicating cancer on biopsies was varied by changing the maximum cancer core length (MCCL) and total cancer core length (TCCL) within each sector from 1 mm to 10 mm. The sensitivity, specificity, and positive (PPVs) and negative predictive values (PPVs) were calculated for each MCCL and TCCL. Gleason ≤3+3 and Gleason ≥3+4 cancers were analyzed separately. RESULTS: Mean age was 62 years (range, 40-76 years), and mean prostate-specific antigen level was 8.2 μg/L (range, 2.1-43 μg/L). Fifty percent of quadrants (127 of 256) had prostate cancer, of which 65% (83 of 127) were Gleason ≤3+3. For Gleason ≤3+3, multiparametric MRI had an NPV of ≥95% at an MCCL of ≥5 mm and at a TCCL of ≥7 mm (MRI score ≥3). For Gleason ≥3+4, an NPV of ≥95% was seen at an MCCL of ≥5 mm (MRI score ≥3) and TCCL ≥6 mm. CONCLUSION: Multiparametric MRI may allow areas of the prostate which test negative to avoid biopsy. Whether multiparametric MRI can be used as a "triage" test before the first biopsy requires results from ongoing prospective validating cohort studies

The "Is mpMRI Enough" or IMRIE Study: a multicentre evaluation of prebiopsy multiparametric magnetic resonance imaging compared with biopsy.

Background: Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings. Objective: To assess the diagnostic performance of mpMRI for csPCa in a real-world setting. Design, setting, and participants: A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naïve or have had previous negative biopsies. Outcome measurements and statistical analysis: The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated. Results and limitations: Across ten sites, 2642 men were included (January 2011–November 2018). Mean age and PSA were 65.3 yr (standard deviation [SD] 7.8 yr) and 7.5 ng/ml (SD 3.3 ng/ml), respectively. Of the patients, 35.9% had “negative MRI” (scores 1–2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG ≥ 2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15 ng/ml/ml was used in MRI scores 1–2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12 ng/ml/ml. ISUP GG ≥ 3 (Gleason ≥4 + 3) was found in 2.4% (15/617) of men with MRI scores 1–2. They key limitations of this study are the heterogeneity and retrospective nature of the data. Conclusions: Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers