Comparison of Positive Predictive Values of Biparametric MRI and Multiparametric MRI-directed Transrectal US-guided Targeted Prostate Biopsy.

Background Biparametric MRI (bpMRI) of the prostate is an alternative to multiparametric MRI (mpMRI), with lower cost and increased accessibility. Studies investigating the positive predictive value (PPV) of bpMRI-directed compared with mpMRI-directed targeted biopsy are lacking in the literature. Purpose To compare the PPVs of bpMRI-directed and mpMRI-directed targeted prostate biopsies. Materials and Methods This retrospective cross-sectional study evaluated men who underwent bpMRI-directed or mpMRI-directed transrectal US (TRUS)-guided targeted prostate biopsy at a single institution from January 2015 to December 2022. The PPVs for any prostate cancer (PCa) and clinically significant PCa (International Society of Urological Pathology grade ≥2) were calculated for bpMRI and mpMRI using mixed-effects logistic regression modeling. Results A total of 1538 patients (mean age, 67 years ± 8 [SD]) with 1860 lesions underwent bpMRI-directed (55%, 849 of 1538) or mpMRI-directed (45%, 689 of 1538) prostate biopsy. When adjusted for the number of lesions and Prostate Imaging Reporting and Data System (PI-RADS) score, there was no difference in PPVs for any PCa or clinically significant PCa (P = .61 and .97, respectively) with bpMRI-directed (55% [95% CI: 51, 59] and 34% [95% CI: 30, 38], respectively) or mpMRI-directed (56% [95% CI: 52, 61] and 34% [95% CI: 30, 39], respectively) TRUS-guided targeted biopsy. PPVs for any PCa and clinically significant PCa stratified according to clinical indication were as follows: biopsy-naive men, 64% (95% CI: 59, 69) and 43% (95% CI: 39, 48) for bpMRI, 67% (95% CI: 59, 75) and 51% (95% CI: 43, 59) for mpMRI (P = .65 and .26, respectively); and active surveillance, 59% (95% CI: 49, 69) and 30% (95% CI: 22, 39) for bpMRI, 73% (95% CI: 65, 89) and 38% (95% CI: 31, 47) for mpMRI (P = .04 and .23, respectively). Conclusion There was no evidence of a difference in PPV for clinically significant PCa between bpMRI- and mpMRI-directed TRUS-guided targeted biopsy. © RSNA, 2024 Supplemental material is available for this article.

Estimated glomerular filtration rate from the renal hypothermia trial: clinical implications.

OBJECTIVE: To assess if estimated glomerular filtration rate (eGFR) can replace measured GFR (mGFR) in partial nephrectomy (PN) trials, using data from a randomised clinical trial. PATIENTS AND METHODS: We conducted a post hoc analysis of the renal hypothermia trial. Patients underwent mGFR with diethylenetriaminepentaacetic acid (DTPA) plasma clearance preoperatively and 1 year after PN. The eGFR was calculated using the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equations incorporating age and sex, with and without race: 2009 eGFRcr(ASR) and 2009 eGFRcr(AS), and the 2021 equation that only incorporates age and sex: 2021 eGFRcr(AS). Performance was evaluated by determining the median bias, precision (interquartile range [IQR] of median bias), and accuracy (percentage of eGFR within 30% of mGFR). RESULTS: Overall, 183 patients were included. Pre- and postoperative median bias and precision were similar between the 2009 eGFRcr(ASR) (-0.2 mL/min/1.73 m2 , 95% confidence interval [CI] -2.2 to 1.7, IQR 18.8; and -2.9, 95% CI -5.1 to -1.5, IQR 15, respectively) and 2009 eGFRcr(AS) (-0.3 mL/min/1.73 m2 , 95% CI -2.4 to 1.5, IQR 18.8; and -3.0, 95% CI -5.7 to -1.7, IQR 15.0, respectively). Bias and precision were worse for the 2021 eGFRcr(AS) (-8.8 mL/min/1.73 m2 , 95% CI -10.9 to -6.3, IQR 24.7; and -12.0, 95% CI -15.8 to -8.9, IQR 23.5, respectively). Similarly, pre- and postoperative accuracy was >90% for the 2009 eGFRcr(ASR) and 2009 eGFRcr(AS) equations. Accuracy was 78.6% preoperatively and 66.5% postoperatively for 2021 eGFRcr(AS). CONCLUSION: The 2009 eGFRcr(AS) can accurately estimate GFR in PN trials and could be used instead of mGFR to reduce cost and patient burden.

Complete Remission of BCG-Refractory High-grade Bladder CIS with Pharmacologic Ascorbate and Mistletoe.

Context: Bladder cancer is the fourth-most-common cancer in males in the U.S., who develop about 90% of the high-grade, carcinoma in situ (CIS) of non-muscle involved disease (NMIBC). Smoking and occupational carcinogens are well-known causes. For females without known risk factors, bladder cancer can be regarded as a sentinel environmental cancer. It's also one of the costliest to treat due to its high rate of recurrence. No treatment innovations have occurred in nearly two decades; intravesical instillation of Bacillus Calmette-Guerin (BCG), an agent in short supply globally, or Mitomycin-C (MIT-C) is effective in about 60% of cases. Cases refractory to BCG and MIT-C often undergo cystectomy, a procedure with numerous impacts on life styles and potential complications. The recent completion of a small Phase I trial of mistletoe in cancer patients that have exhausted known treatments at Johns Hopkins provides corroboration of its safety, with 25 % showing no disease progression. Objective: The study examined the benefits of pharmacologic ascorbate (PA) and mistletoe for a nonsmoking female patient with an environmental history of NMIBC refractory to BCG, in a non-smoking female with exposures in childhood and early adult life to several known carcinogens, including ultrafine particulate air pollution, benzene, toluene, and other organic solvents, aromatic amines and engine exhausts, and possibly arsenic in water. Design: The research team performed an integrative oncology case study on pharmacologic ascorbate (PA) and mistletoe, both agents shown to activate NK cells, enhance growth and maturation of T-cells, and induce dose-dependent pro-apoptotic cell death, suggesting shared and potentially synergistic mechanisms. Setting: The study began at the University of Ottawa Medical Center in Canada with treatment continuing over six years at St. Johns Hospital Center in Jackson, Wyoming, and George Washington University Medical Center for Integrative Medicine, with surgical, cytological, and pathological evaluations at University of California San Francisco Medical Center. Participant: The patient in the case study was a 76-year-old, well-nourished, athletic, nonsmoking female with high-grade CIS of the bladder. Her cancer was considered to be a sentinel environmental cancer. Intervention: Intravenous pharmacologic ascorbate (PA) and subcutaneous mistletoe (three times weekly) and intravenous and intravesical mistletoe (once weekly) were employed for an 8-week induction treatment, using a dose-escalation protocol as detailed below. Maintenance therapy was carried out with the same protocol for three weeks every three months for two years. Results: The patient has experienced a cancer-free outcome following 78 months of treatments that incorporated intravesical, intravenous, and subcutaneous mistletoe; intravenous PA; a program of selected nutraceuticals; exercise; and other supplementary treatments. Conclusions: This study is the first reported instance of combined treatments to achieve complete remission for high-grade NMIBC refractory to BCG and MIT-C, using intravesical, subcutaneous, and intravenous mistletoe and intravenous PA. It includes pharmacological information on possible mechanisms. In light of the global shortage of BCG, the high proportion of cases refractory to BCG and MIT-C, the unproven use of costly off-label pharmaceuticals, such as gemcitabine, and the relative cost-effectiveness of mistletoe and PA, clinicians should give serious consideration to employing these combined functional medicine treatments for BCG- and MIT-C-refractory NMIBC. Further research is needed with additional patients that can advance our understanding, including standardization of methods for systematically evaluating combined therapies-blinded and non-blinded, nomenclature regarding mistletoe preparation, doses, concentrations, regimes of administration, lengths of treatment, targeted cancer types, and other aspects.

Performance Feedback May Not Improve Radical Prostatectomy Outcomes: The Surgical Report Card (SuRep) Study.

PURPOSE: Oncologic, urinary, and sexual outcomes are important to patients receiving prostate cancer surgery. The objective of this study was to determine if providing surgical report cards (SuReps) to surgeons resulted in improved patient outcomes. MATERIALS AND METHODS: A prospective before-and-after study was conducted at The Ottawa Hospital. A total of 422 consecutive patients undergoing radical prostatectomy were enrolled. The intervention was provision of report cards to surgeons. The control cohort was patients treated before report card feedback (pre-SuRep), and the intervention cohort was patients treated after report card feedback (post-SuRep). The primary outcomes were postoperative erectile function, urinary continence, and positive surgical margins. RESULTS: Baseline characteristics were similar between groups. Almost all patients (99%) were continent and the majority (59%) were potent prior to surgery. Complete 1-year followup was available for 400 patients (95%). Nerve sparing surgery increased from 70% pre-SuRep to 82% post-SuRep (p=0.01). There was a nonstatistically significant increase in the proportion of patients with a positive surgical margin post-SuRep (31% pre-SuRep vs 39% post-SuRep, p=0.08). There was no difference in postoperative erectile function (17% vs 18%, p=0.7) and a decrease in continence (75% vs 65%, p=0.02) at 1 year postoperatively. CONCLUSIONS: The SuRep platform allows accurate reporting of surgical outcomes that can be used for patient counseling. However, the provision of surgical report cards did not improve functional or oncologic outcomes. Longer durations of feedback, report card modifications, or targeted interventions are likely necessary to improve outcomes.

Hypothermia During Partial Nephrectomy for Patients with Renal Tumors: A Randomized Controlled Trial.

PURPOSE: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. MATERIALS AND METHODS: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m2 at a 5% significance level. RESULTS: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m2 in the hypothermia group and -7.8 ml/minute/1.73 m2 in the control group (mean difference 1.2 ml/minute/1.73 m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m2; mean difference 0.5 ml/minute/1.73 m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. CONCLUSIONS: Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.

Thromboprophylaxis practice patterns and beliefs among physicians treating patients with abdominopelvic cancers at a Canadian centre.

Background: There is inadequate high-quality evidence on thromboprophylaxis for patients undergoing surgery for abdominopelvic cancer. We surveyed physicians who treat patients with abdominopelvic cancer to determine current thromboprophylaxis practice patterns and to determine where research is needed. Methods: We created an online survey with questions on thromboprophylaxis topics, including type of thromboprophylaxis used, timing of initial thromboprophylaxis dose, use of thromboprophylaxis during chemotherapy, use of extended-duration thromboprophylaxis and areas for future research. The survey questions were reviewed by external content experts to ensure they were appropriate and relevant. Surgeons, thrombosis experts and medical oncologists who manage patients with abdominopelvic cancers at 1 large Canadian academic centre were invited to complete the survey between January and April 2019. Results: Of the 57 physicians invited, 42 (74%) completed the survey, including 27 surgeons (response rate 79%), 9 thrombosis experts (response rate 75%) and 6 medical oncologists (response rate 55%). Most surgeons (22 [82%]) reported using mechanical thromboprophylaxis, whereas only 1 thrombosis expert (11%) recommended mechanical thromboprophylaxis. There was substantial variability in the timing of the initial dose of thromboprophylaxis, with 9/10 urologists (90%) and all 7 general surgeons giving the first dose intraoperatively, and three-quarters of thoracic surgeons (3/4 [75%]), gynecologists (3/4 [75%]) and thrombosis experts (7/9 [78%]) starting thromboprophylaxis after surgery. All medical oncologists believed chemotherapy increases the risk of venous thromboembolism, but 4 (67%) reported that they do not routinely prescribe thromboprophylaxis owing to bleeding concerns. Most respondents (35/38 [92%]) felt there was a need for more research on thromboprophylaxis and indicated willingness to participate in future clinical trials. Conclusion: Variability exists in contemporary thromboprophylaxis practice patterns among physicians treating patients with abdominopelvic cancer. Future research is needed to standardize care and improve outcomes for patients.

Contexte: On manque de données de qualité élevée sur la thromboprophylaxie chez les patients traités en chirurgie pour un cancer abdomino-pelvien. Nous avons sondé des médecins traitant ces patients afin de déterminer les tendances actuelles relatives à cette pratique et pour cerner les besoins en recherche. Méthodes: Nous avons créé un sondage en ligne sur la thromboprophylaxie, comprenant des questions sur le type utilisé, le moment d'administration de la dose initiale, le recours durant la chimiothérapie, l'utilisation prolongée et les domaines de recherche à explorer. Les questions ont été validées par des experts de contenu externes, qui ont veillé à ce qu'elles soient appropriées et pertinentes. Des chirurgiens, des experts en thrombose et des oncologues qui s'occupent de patients atteints de cancers abdomino-pelviens dans un grand centre hospitalier universitaire canadien ont été invités à remplir le sondage entrer janvier et avril 2019. Résultats: Des 57 médecins sollicités, 42 (74%) ont répondu au sondage, dont 27 chirurgiens (taux de réponse de 79%), 9 experts en thrombose (taux de réponse de 75 %) et 6 oncologues (taux de réponse de 55 %). La majorité des chirurgiens (22 [82 %]) recouraient à la thromboprophylaxie mécanique, alors qu'un seul expert en thrombose (11 %) recommandait cette pratique. Le moment d'administration de la dose initiale variait considérablement: 9 urologues sur 10 (90%) et chacun des 7 chirurgiens généralistes administraient la première dose durant l'opération, alors que les trois quarts des chirurgiens thoraciques (3/4 [75%]), des gynécologues (3/4 [75%]) et des experts en thrombose (7/9 [78%]) commençaient la thromboprophylaxie après l'intervention. Tous les oncologues étaient d'avis que la chimiothérapie augmentait le risque de thromboembolie veineuse, mais 4 (67%) ont indiqué qu'ils ne prescrivaient pas d'emblée de thromboprophylaxie en raison des risques de saignements. La plupart des répondants (35/38 [92%]) considéraient qu'il faudrait étudier davantage la thromboprophylaxie et ont indiqué leur volonté de participer à d'éventuels essais cliniques. Conclusion: À l'heure actuelle, les pratiques liées à la thromboprophylaxie varient chez les médecins traitant des patients atteints de cancers abdomino-pelviens. Il faudra mener d'autres études pour normaliser la prestation des soins et améliorer les résultats pour les patients.

Development and Acceptability Testing of a Patient Decision Aid for Urinary Diversion with Radical Cystectomy.

PURPOSE: The choice of urinary diversion at cystectomy is a life altering decision. Patient decision aids are clinical tools that promote shared decision making by providing information about management options and helping patients communicate their values. We sought to develop and evaluate a patient decision aid for individuals undergoing cystectomy with urinary diversion. MATERIALS AND METHODS: We used the IPDAS (International Patient Decision Aids Standards) to guide a systematic development process. A literature review was performed to determine urinary diversion options and the incidence of outcomes. We created a prototype using the Ottawa Decision Support Framework. A 10-question survey was used to assess patient decision aid acceptability among patients, allied health professionals and urologists. The primary outcome was acceptability of the patient decision aid. RESULTS: Ileal conduit and orthotopic neobladder were included as primary urinary diversion options because they had the most evidence and are most commonly performed. Continent cutaneous diversion was identified as an alternative option. Outcomes specific to ileal conduit were stomal stenosis and parastomal hernia. Outcomes specific to neobladder were daytime and nighttime urinary incontinence and urinary retention. Acceptability testing was completed by 8 urologists, 9 patients and 1 advanced practice nurse. Of the respondents 94% reported that the language was appropriate, 94% reported that the length was adequate and 83% reported that option presentation was balanced. The patient decision aid met all 6 IPDAS defining criteria, all 6 certification criteria and 21 of 23 quality criteria. CONCLUSIONS: We created a novel patient decision aid to improve the quality of decisions made by patients when deciding among urinary diversion options. Effectiveness testing will be performed prospectively.

Multiparametric Versus Biparametric Prostate MRI: Comparison of NPV for Clinically Significant Prostate Cancer.

In this single-center retrospective study, multiparametric and biparametric prostate MRI showed no statistically significant difference in NPV for clinically significant prostate cancer, including in subgroups of patients on active surveillance and with no prior prostate cancer history.

Regional Standardization of Prostate Multiparametric MRI Performance and Reporting: Is There a Role for a Director of Prostate Imaging?

OBJECTIVE. The purpose of this study was to assess prostate multiparametric MRI (mpMRI) before and after intervention by a director of prostate imaging. MATERIALS AND METHODS. Images from prostate mpMRI examinations at four peripheral institutions (five 1.5-T systems) were studied. DICOM headers were analyzed for T2-weighted, DWI, and dynamic contrast-enhanced technical specifications. Reports were retrieved, and a blinded radiologist compared them with those from the regional academic referral center (3-T system) and Prostate Imaging and Data Reporting System version 2 (PI-RADSv2) technical specifications. Data were reevaluated after intervention by a director of prostate imaging. Comparisons were performed by chi-square analysis. RESULTS. Except for having insufficient DWI spatial resolution, the referral center fully complied with PI-RADSv2. For peripheral systems, compliance with PI-RADSv2 technical specifications improved from baseline to after intervention. For T2-weighted imaging, compliance with spatial resolution increased from 40% (two of five MRI systems) to 100% (all five systems) (p = 0.038). For DWI, spatial resolution compliance increased from 20% to 100%. For modified DWI, spatial resolution compliance to improve image quality at 1.5 T (matrix, 100 × 100; FOV, 28 × 28 cm; slice thickness, 4 mm) increased from 60% (b value ≥ 1400 s/mm2) to 100% (p = 0.114). For dynamic contrast-enhanced imaging, spatial resolution compliance increased from 60% to 100% (p = 0.114), temporal resolution compliance increased from 20% (≤ 10 seconds) to 100% (p = 0.10), and acquisition time compliance increased from 60% (≥ 2 minutes) to 100% (p = 0.114). Only one of the four peripheral centers provided PI-RADSv2 scores, but all of them did after the intervention (p = 0.028). CONCLUSION. A director of prostate imaging may drive standardization of prostate MRI performance and reporting within specified geographic regions.

ADC Metrics From Multiparametric MRI: Histologic Downgrading of Gleason Score 9 or 10 Prostate Cancers Diagnosed at Nontargeted Transrectal Ultrasound-Guided Biopsy.

OBJECTIVE: The purpose of this study was to evaluate quantitative apparent diffusion coefficient (ADC) metrics for the downgrading of Gleason score (GS) 9 or 10 prostate cancer (PCa) diagnosed by means of nontargeted transrectal ultrasound-guided biopsy. MATERIALS AND METHODS: Between 2012 and 2015, 30 men with a diagnosis of GS 9 or 10 PCa at nontargeted transrectal ultrasound-guided biopsy underwent 3-T multiparametric MRI before radical prostatectomy (RP). Two radiologists blinded to the histopathologic results independently assessed multiparametric MR images using Prostate Imaging Reporting and Data System (PI-RADS) version 2. Whole-lesion ADC mean, centile, and texture features were extracted from coregistered ADC and RP maps by a third blinded radiologist. Comparisons were performed by chi-square, multivariable logistic regression, and ROC analysis. RESULTS: Tumors were downgraded to intermediate risk (GS 4 + 3 [n = 7] and GS 3 + 4 [n = 2]) PCa in 30.0% (9/30) of men after RP. There were no statistically significant differences between groups with respect to age (p = 0.028), prostate-specific antigen level (p = 0.018), or clinical stage (p = 0.021). PI-RADS version 2 scores did not differ between groups (p = 0.035, p = 0.091) with moderate agreement (κ = 0.48). There were no differences in mean or centile ADC (p = 0.269-0.634) between the two groups. ADC entropy was significantly lower in downgraded tumors (5.542 ± 0.721 [SD] vs 8.089 ± 1.237, p < 0.001) with no difference in kurtosis or skewness (p = 0.133, p = 0.296). The ROC AUC for the diagnosis of downgrading was 0.93 (95% CI, 0.84-1.00) with sensitivity of 85.7% and specificity of 88.9% when entropy was less than 6.31. CONCLUSION: ADC entropy was significantly lower in GS 9 and 10 tumors diagnosed by means of nontargeted transrectal ultrasound-guided biopsy that were eventually downgraded to intermediate risk (GS 7) after RP. ADC texture analysis may be useful for further risk stratification of PCa diagnosed at biopsy.

The Risks and Benefits of Cavernous Neurovascular Bundle Sparing during Radical Prostatectomy: A Systematic Review and Meta-Analysis.

PURPOSE: We summarize published data on associations between cavernous neurovascular bundle preservation (nerve sparing) during prostatectomy and positive surgical margins, erectile function, urinary function and other patient reported outcomes. MATERIALS AND METHODS: A systematic literature search of MEDLINE®, Embase® and Cochrane Reviews databases was performed for interventional or observational studies published between 2000 and 2014. English language articles that compared clinical outcomes of patients undergoing nerve sparing and nonnerve sparing radical prostatectomy were included. Meta-analyses were performed to calculate pooled relative risk estimates for positive surgical margins, erectile dysfunction and urinary incontinence in nerve sparing and nonnerve sparing groups. Sensitivity analyses compared outcomes among unilateral and bilateral nerve sparing vs nonnerve sparing groups. RESULTS: Of the 1,883 articles identified, 124 studies (73,448 patients) were included in the analysis. Nerve sparing did not increase the risk of positive surgical margins in patients with pT2 (RR 0.92, 95% CI 0.75-1.13) or pT3 disease (RR 0.83, 95% CI 0.71-0.96), potentially due to appropriate patient selection. The risk of incontinence was lower in nerve sparing cases (RR 0.75, 95% CI 0.65-0.85 and RR 0.61, 95% CI 0.44-0.84) at 3 and 12 months, respectively. The relative risk of erectile dysfunction with nerve sparing was 0.77 (95% CI 0.70-0.85) at 3 months and 0.53 (95% CI 0.39-0.71) at 12 months. Subgroup analyses of unilateral and bilateral nerve sparing approaches demonstrated similar results. CONCLUSIONS: Among cohort studies nerve sparing was not associated with worse cancer outcomes. Nerve sparing is associated with better urinary and erectile function. These results should be interpreted with caution given the potential for selection bias and unadjusted confounding factors.

Prognostic value of Prostate Imaging and Data Reporting System (PI-RADS) v. 2 assessment categories 4 and 5 compared to histopathological outcomes after radical prostatectomy.

PURPOSE: To assess Prostate Imaging and Data Reporting System (PI-RADS) v. 2 score 4/5 lesions compared to Gleason score (GS) and stage after radical prostatectomy (RP) and to validate the proposed 15-mm size threshold that differentiates category 4 versus 5 lesions. MATERIALS AND METHODS: With Institutional Review Board (IRB) approval, 140 men underwent 3T magnetic resonance imaging (MRI) and RP between 2012-2015. Two blinded radiologists: 1) assigned PI-RADS v. 2 scores, 2) measured tumor size on axial T2 -weighted-MRI, and 3) assessed for extraprostatic extension (EPE). Interobserver agreement was calculated and consensus diagnoses achieved through reference standard (MRI-RP maps). PI-RADS v. 2 scores and tumor size were compared to GS and stage using chi-square, analysis of variance (ANOVA), and receiver operating characteristic (ROC) curve analysis. RESULTS: In all, 80.7% (113/140) of tumors were category 4 (n = 45) or 5 (n = 68) lesions (κ = 0.45). Overall tumor size was 18.2 ± 7.7 mm and category 5 lesions were larger (22.6 ± 6.8 versus 11.5 ± 1.9 mm, P < 0.001). High-risk (GS ≥8) tumors were larger than low- and intermediate-risk tumors (P = 0.016) and were more frequently, but not significantly so, category 5 lesions (78.9% [15/19] vs. 22.1% [4/10], P = 0.18). 67.3% (76/113) of patients had EPE. Category 5 lesions were strongly associated with EPE (P < 0.0001). Area under the ROC curve for diagnosis of EPE by size was 0.74 (confidence interval 0.64-0.83), with size ≥15 mm yielding a sensitivity/specificity of 72.4/64.9%. Size improved sensitivity for diagnosis of EPE compared to subjective assessment (sensitivity/specificity ranging from 46.1-48.7%/70.3-86.5%, κ = 0.29) (P = 0.028). CONCLUSION: PI-RADS v. 2 category 5 lesions are associated with higher Gleason scores and EPE. A 15-mm size threshold is reasonably accurate for diagnosis of EPE with increased sensitivity compared to subjective assessment. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. MAGN. RESON. IMAGING 2017;46:257-266.

MRI assessment of pathological stage and surgical margins in anterior prostate cancer (APC) using subjective and quantitative analysis.

PURPOSE: To evaluate magnetic resonance imaging (MRI) for assessment of extraprostatic extension (EPE) and positive surgical margins (PSM) in anterior prostate cancer (APC). MATERIALS AND METHODS: With Institutional Review Board approval, 25 APC (>2/3 of tumor anterior to urethra) were assessed using 3T MRI by two blinded radiologists for: size and maximal leading edge of tumor (relative to anterior fibromuscular stroma [AFMS]) on b ≥1000 sec/mm2 echo-planar-MRI fused onto T2 -weighted-MRI, invasion of AFMS and EPE. Comparisons were performed between APCs by EPE/PSM using chi-square, multivariable analysis, and receiver operator characteristic (ROC) analysis. RESULTS: The prevalence of EPE and PSM were 52% (13/25) and 36% (9/25). Tumor sizes were larger with EPE (22.5 ± 8.4 vs. 14.7 ± 6.3, P = 0.02) and PSM (23.0 ± 9.3 vs. 16.4 ± 7.0, P = 0.06). Area under ROC curve (AUC-ROC) for the diagnosis of EPE by tumor size was 0.77 (95% confidence interval [CI] 0.58-0.95); ≥16 mm size = sensitivity/specificity 69.2/66.7%. Maximal leading edge of tumor was greater with EPE (2.4 ± 2.2 vs. -0.2 ± 3.0) and PSM (2.8 ± 2.3 vs. -0.3 ± 2.5), (P = 0.023, 0.031). AUC-ROC for diagnosis of EPE/PSM by leading edge was 0.78 (CI 0.57-0.97) and 0.75 (CI 0.56-0.94). A ≥1 mm leading edge yielded sensitivity/specificity of 76.9/75.0% and 77.8/62.5% for diagnosis of EPE/PSM. 60-72% (15-18/25) tumors invaded AFMS (k = 0.74), which was not associated with EPE/PSM (P = 0.12-0.14). Radiologists' assessment of EPE had sensitivity/specificity of 61.5-69.2/50.0-75.0% (k = 0.53). CONCLUSION: Tumor size and leading edge of tumor relative to AFMS may enable diagnosis of EPE and positive surgical margins in APC. LEVEL OF EVIDENCE: 2 J. MAGN. RESON. IMAGING 2017;45:1296-1303.

Development and external validation of a biopsy-derived nomogram to predict risk of ipsilateral extraprostatic extension.

OBJECTIVES: To develop and externally validate a nomogram that predicts risk of side-specific extraprostatic extension (EPE) at time of surgery, using commonly available preoperative markers. MATERIALS AND METHODS: A consecutive sample of 753 men treated by radical prostatectomy (RP) at the University Health Network, Toronto, between 2009 and 2015, was used to develop the nomogram. The validation cohort consisted of 311 men treated by RP at Ottawa Hospital Research Institute, between 1992 and 2014. The study outcome was presence of ipsilateral EPE. The association between predictors considered and EPE was tested using univariate and multivariate logistic regression analyses. The predictive accuracy of the nomogram was determined using the area under the receiver-operating characteristic curve. RESULTS: The overall rate of EPE was 19.8% of all lobes in the developmental cohort and 28.9% in the validation cohort. Significant variables in the models were age, prostate-specific antigen and ipsilateral Gleason score, percentage of positive cores and highest core involvement (all P < 0.05). The nomogram predicting risk of EPE had a predictive accuracy of 0.74 in the external validation cohort. CONCLUSION: We developed and externally validated a nomogram that predicts the risk of ipsilateral EPE based on commonly used preoperative markers. This nomogram may be used to assist surgical decision-making prior to RP.

Prostate Imaging Reporting and Data System, Version 2, Assessment Categories and Pathologic Outcomes in Patients With Gleason Score 3 + 4 = 7 Prostate Cancer Diagnosed at Biopsy.

OBJECTIVE: The purpose of this study is to assess associations between Prostate Imaging Reporting and Data System, version 2 (PI-RADSv2), categories and the presence of a tumor with a Gleason score (GS) of 4 + 3 = 7 or greater or the presence of extraprostatic extension (EPE) at radical prostatectomy (RP) in patients with a GS 3 + 4 = 7 tumor at biopsy. MATERIALS AND METHODS: A total of 81 men with GS 3 + 4 = 7 prostate cancer diagnosed by transrectal ultrasound-guided biopsy underwent multiparametric MRI and RP between 2012 and 2015. Two blinded radiologists assessed multiparametric MR images and assigned PI-RADSv2 assessment categories (categories 1-5) with the use of sector maps, which were compared with regard to the location of the tumor, the GS, and the presence of EPE at RP. Comparisons were performed between groups with the use of chi-square and multivariate analysis. Diagnostic accuracy was assessed using ROC curve analysis, and localization was compared using the Fisher exact test. RESULTS: A total of 53.1% of men (43/81) had EPE, and 21.0% (17/81) had GS 4 + 3 = 7 prostate cancer after RP, whereas 2.5% of men (2/81) had their tumors downgraded to GS 3 + 3 = 6. No statistically significant difference in patient age, prostate specific antigen level, or clinical stage existed between groups (p > 0.05). PI-RADSv2 assessment categories were significantly higher for GS 4 + 3 = 7 tumors (p = 0.03). PI-RADSv2 showed moderate accuracy for the diagnosis of GS 4 + 3 = 7 tumors (AUC, 0.65; 95% CI, 0.54-0.77), with a category of 4 or higher having a sensitivity and specificity for diagnosis of 94.1% and 23.4%, respectively. No patient with a PI-RADSv2 category lower than 3 had a GS 4 + 3 = 7 tumor. Accuracy of tumor localization ranged from 86.4% to 92.6%, with 88.2% of errors (15/17) occurring in GS 3 + 3 = 6 or GS 3 + 4 = 7 tumors (p = 0.30). PI-RADSv2 categories were noted to be higher when EPE was present (p < 0.001). Interobserver agreement was moderate (κ = 0.43). CONCLUSION: For GS 3 + 4 = 7 cancers detected at transrectal ultrasound-guided biopsy, higher PI-RADSv2 assessment categories are associated with upgrading to GS 4 + 3 = 7 cancer and with the presence of EPE after RP. A PI-RADSv2 score of 3 or higher was 100% sensitive for diagnosing GS 4 + 3 = 7 tumors.

Active surveillance in Canadian men with low-grade prostate cancer.

BACKGROUND: Recent guidelines recommend against routine screening for prostate cancer, partly because of the risks associated with overtreatment of clinically indolent tumours. We aimed to determine the proportion of patients whose low-grade prostate cancer was managed by active surveillance instead of immediate treatment. METHODS: We reviewed data for patients who were referred to the Ottawa regional Prostate Cancer Assessment Clinic with abnormal results for prostate-specific antigen (PSA) or prostate examination between Apr. 1, 2008, and Jan. 31, 2013. Patients with subsequent biopsy-proven low-grade (Gleason score 6) cancer were included. Active surveillance was defined a priori as monitoring by means of PSA, digital rectal examination and repeat biopsies, with the potential for curative-intent treatment in the event of disease progression. RESULTS: Of 477 patients with low-grade cancer, active surveillance was used for 210 (44.0%), and the annual proportion increased from 32% (11/34) in 2008 to 67% (20/30) in 2013. Factors associated with immediate treatment were palpable tumour, PSA density above 0.2 ng/mL(2) and more than 2 positive biopsy cores. Factors associated with surveillance were age over 70 years and higher Charlson comorbidity index. Of 173 men who received immediate surgical treatment, 103 (59.5%) had higher-grade or advanced-stage disease on final pathologic examination. Of the 210 men with active surveillance, 62 (29.5%) received treatment within a median of 1.3 years, most commonly (52 [84%]) because of upgrading of disease on the basis of surveillance biopsy. INTERPRETATION: Active surveillance has become the most common management strategy for men with low-grade prostate cancer at our regional diagnostic centre. Factors associated with immediate treatment reflected those that increase the risk of higher-grade tumours.