Samir S. Taneja

Standards of Reporting for MRI-targeted Biopsy Studies (START) of the Prostate: Recommendations from an International Working Group.

BACKGROUND 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.

A Prospective, Blinded Comparison of Magnetic Resonance (MR) Imaging–Ultrasound Fusion and Visual Estimation in the Performance of MR-targeted Prostate Biopsy: The PROFUS Trial

BACKGROUND Increasing evidence supports the use of magnetic resonance (MR)-targeted prostate biopsy. The optimal method for such biopsy remains undefined, however. OBJECTIVE To prospectively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting. DESIGN, SETTING, AND PARTICIPANTS From June 2012 to March 2013, prospective targeted biopsy was performed in 125 consecutive men with suspicious regions identified on prebiopsy 3-T MRI consisting of T2-weighted, diffusion-weighted, and dynamic-contrast enhanced sequences. INTERVENTION Two MRI-ultrasound fusion targeted cores per target were performed by one operator using the ei-Nav|Artemis system. Targets were then blinded, and a second operator took two visually targeted cores and a 12-core biopsy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Biopsy information yield was compared between targeting techniques and to 12-core biopsy. Results were analyzed using the McNemar test. Multivariate analysis was performed using binomial logistic regression. RESULTS AND LIMITATIONS Among 172 targets, fusion biopsy detected 55 (32.0%) cancers and 35 (20.3%) Gleason sum ≥7 cancers compared with 46 (26.7%) and 26 (15.1%), respectively, using visual targeting (p=0.1374, p=0.0523). Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual (p=0.0104). Targeted biopsy detected 75.0% of all clinically significant cancers and 86.4% of Gleason sum ≥7 cancers detected on standard biopsy. On multivariate analysis, fusion performed best among smaller targets. The study is limited by lack of comparison with whole-gland specimens and sample size. Furthermore, cancer detection on visual targeting is likely higher than in community settings, where experience with this technique may be limited. CONCLUSIONS Fusion biopsy was more often histologically informative than visual targeting but did not increase cancer detection. A trend toward increased detection with fusion biopsy was observed across all study subsets, suggesting a need for a larger study size. Fusion targeting improved accuracy for smaller lesions. Its use may reduce the learning curve necessary for visual targeting and improve community adoption of MR-targeted biopsy.

Prostate cancer localization using multiparametric MR imaging: comparison of Prostate Imaging Reporting and Data System (PI-RADS) and Likert scales.

PURPOSE To compare the recently proposed Prostate Imaging Reporting and Data System (PI-RADS) scale that incorporates fixed criteria and a standard Likert scale based on overall impression in prostate cancer localization using multiparametric magnetic resonance (MR) imaging. MATERIALS AND METHODS This retrospective study was HIPAA compliant and institutional review board approved. Seventy patients who underwent 3-T pelvic MR imaging, including T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast material-enhanced imaging, with a pelvic phased-array coil before radical prostatectomy were included. Three radiologists, each with 6 years of experience, independently scored 18 regions (12 peripheral zone [PZ], six transition zone [TZ]) using PI-RADS (range, scores 3-15) and Likert (range, scores 1-5) scales. Logistic regression for correlated data was used to compare scales for detection of tumors larger than 3 mm in maximal diameter at prostatectomy. RESULTS Maximal accuracy was achieved with score thresholds of 8 and higher and of 3 and higher for PI-RADS and Likert scales, respectively. At these thresholds, in the PZ, similar accuracy was achieved with the PI-RADS scale and the Likert scale for radiologist 1 (89.0% vs 88.2%, P = .223) and radiologist 3 (88.5% vs 88.2%, P = .739) and greater accuracy was achieved with the PI-RADS scale than the Likert scale for radiologist 2 (89.6% vs 87.1%, P = .008). In the TZ, accuracy was lower with the PI-RADS scale than with the Likert scale for radiologist 1 (70.0% vs 87.1%, P < .001), radiologist 2 (87.6% vs 92.6%, P = .002), and radiologist 3 (82.9% vs 91.2%, P < .001). For tumors with Gleason score of at least 7, sensitivity was higher with the PI-RADS scale than with the Likert scale for radiologist 1 (88.6% vs 82.6%, P = .032), and sensitivity was similar for radiologist 2 (78.0% vs 76.5, P = .467) and radiologist 3 (77.3% vs 81.1%, P = .125). CONCLUSION Radiologists performed well with both PI-RADS and Likert scales for tumor localization, although, in the TZ, performance was better with the Likert scale than the PI-RADS scale. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.13122233/-/DC1.

Robot Assisted Laparoscopic Partial Nephrectomy: Initial Experience

PURPOSE Advances in laparoscopy have made laparoscopic partial nephrectomy a technically feasible procedure but it remains challenging to even experienced laparoscopists. We hypothesized that robotic assisted laparoscopic partial nephrectomy may make this procedure more efficacious than the standard laparoscopic approach. MATERIALS AND METHODS Ten patients with a mean age of 58 years and mean tumor size of 2.0 cm underwent robotic assisted laparoscopic partial nephrectomy and another 10 with a mean age of 61 years and mean tumor size of 2.18 cm underwent laparoscopic partial nephrectomy, as performed by a team of 2 surgeons (MS and ST) between May 2002 and January 2004. Demographic data, intraoperative parameters and postoperative data were compared between the 2 groups. RESULTS There were no significant differences in patient demographics between the 2 groups. Intraoperative data and postoperative outcomes were statistically similar. In the 10 patients who underwent robotic assisted laparoscopic partial nephrectomy there were 2 intraoperative complications. There was 1 conversion in the laparoscopic partial nephrectomy group. CONCLUSIONS Robotic assisted laparoscopic partial nephrectomy is a safe and feasible procedure in patients with small exophytic masses. The robotic approach to laparoscopic partial nephrectomy does not offer any clinical advantage over conventional laparoscopic nephrectomy.

Focal Therapy in Prostate Cancer—Report from a Consensus Panel

PURPOSE To establish a consensus in relation to case selection, conduct of therapy, and outcomes that are associated with focal therapy for men with localized prostate cancer. MATERIAL AND METHODS Urologic surgeons, radiation oncologists, radiologists, and histopathologists from North America and Europe participated in a consensus workshop on focal therapy for prostate cancer. The consensus process was face to face within a structured meeting, in which pertinent clinical issues were raised, discussed, and agreement sought. Where no agreement was possible, this was acknowledged, and the nature of the disagreement noted. RESULTS Candidates for focal treatment should have unilateral low- to intermediate-risk disease with clinical stage <or=cT(2a). Prostate size and both tumor volume and tumor topography are important case selection criteria that depend on the ablative technology used. Currently, the best method to ascertain the key characteristics for men who are considering focal therapy is exposure to transperineal template mapping biopsies. MRI of the prostate using novel techniques such as dynamic contrast enhancement and diffusion weighed imaging are increasingly being used to diagnose and stage primary prostate cancer with excellent results. For general use, however, these new techniques require validation in prospective clinical trials. Until such are performed, MRI will, in most centers, continue to be an investigative tool in assessing eligibility of patients for focal therapy. CONCLUSIONS Consensus was derived for most of the key aspects of case selection, conduct of treatment, and outcome measures for men who are undergoing focal therapy for localized prostate cancer. The level of agreement achieved will pave the way for future collaborative trials.

Prostate Cancer: Feasibility and Preliminary Experience of a Diffusional Kurtosis Model for Detection and Assessment of Aggressiveness of Peripheral Zone Cancer

PURPOSE To assess the feasibility of diffusional kurtosis (DK) imaging for distinguishing benign from malignant regions, as well as low- from high-grade malignant regions, within the peripheral zone (PZ) of the prostate in comparison with standard diffusion-weighted (DW) imaging. MATERIALS AND METHODS The institutional review board approved this retrospective HIPAA-compliant study and waived informed consent. Forty-seven patients with prostate cancer underwent 3-T magnetic resonance imaging by using a pelvic phased-array coil and DW imaging (maximum b value, 2000 sec/mm2). Parametric maps were obtained for apparent diffusion coefficient (ADC); the metric DK (K), which represents non-Gaussian diffusion behavior; and corrected diffusion (D) that accounts for this non-Gaussianity. Two radiologists reviewed these maps and measured ADC, D, and K in sextants positive for cancer at biopsy. Data were analyzed by using mixed-model analysis of variance and receiver operating characteristic curves. RESULTS Seventy sextants exhibited a Gleason score of 6; 51 exhibited a Gleason score of 7 or 8. K was significantly greater in cancerous sextants than in benign PZ (0.96±0.24 vs 0.57±0.07, P<.001), as well as in cancerous sextants with higher rather than lower Gleason score (1.05±0.26 vs 0.89±0.20, P<.001). K showed significantly greater sensitivity for differentiating cancerous sextants from benign PZ than ADC or D (93.3% vs 78.5% and 83.5%, respectively; P<.001), with equal specificity (95.7%, P>.99). K exhibited significantly greater sensitivity for differentiating sextants with low- and high-grade cancer than ADC or D (68.6% vs 51.0% and 49.0%, respectively; P≤.004) but with decreased specificity (70.0% vs 81.4% and 82.9%, respectively; P≤.023). K had significantly greater area under the curve for differentiating sextants with low- and high-grade cancer than ADC (0.70 vs 0.62, P=.010). Relative contrast between cancerous sextants and benign PZ was significantly greater for D or K than ADC (0.25±0.14 and 0.24±0.13, respectively, vs 0.18±0.10; P<.001). CONCLUSION Preliminary findings suggest increased value for DK imaging compared with standard DW imaging in prostate cancer assessment.

Changes in Renal Function Following Nephroureterectomy May Affect the Use of Perioperative Chemotherapy

BACKGROUND Nephroureterectomy alone fails to adequately treat many patients with advanced upper tract urothelial carcinoma (UTUC). Perioperative platinum-based chemotherapy has been proposed but requires adequate renal function. OBJECTIVE Our aim was to determine whether the ability to deliver platinum-based chemotherapy following nephroureterectomy is affected by postoperative changes in renal function. DESIGN, SETTINGS, AND PARTICIPANTS We retrospectively reviewed data on 388 patients undergoing nephroureterectomy for UTUC between 1991 and 2009. Four institutions were included. INTERVENTION All patients underwent nephroureterectomy. MEASUREMENTS All patients had serum creatinine measured before and after surgery. The value closest to 3 mo after surgery was taken as the postoperative value (range: 2-52 wk). Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated Modification of Diet in Renal Disease study equation. eGFR values before and after surgery were compared using the paired t test. We chose an eGFR of 45 and 60 ml/min per 1.73 m(2) as possible cut-offs for chemotherapy eligibility and compared eligibility before and after surgery using the chi-square test. RESULTS AND LIMITATIONS Our cohort of 388 patients included 233 men (60%) with a median age of 70 yr. Mean eGFR decreased by 24% after surgery. Using a cut-off of 60 ml/min per 1.73 m(2), 49% of patients were eligible for chemotherapy before surgery, but only 19% of patients remained eligible postoperatively. Using a cut-off of 45 ml/min per 1.73 m(2), 80% of patients were eligible preoperatively, but only 55% remained eligible after surgery. This distribution persisted when we limited the analysis to patients with advanced pathologic stage (T3 or higher). Patients older than the median age of 70 yr were more likely to be ineligible for chemotherapy both pre- and postoperatively by either definition, and they were significantly more likely to have an eGFR <45 ml/min per 1.73 m(2) postoperatively, regardless of their starting eGFR. This study is limited by its retrospective nature, and there was some variability in the timing of postoperative serum creatinine measurements. CONCLUSIONS eGFR is significantly diminished after nephroureterectomy, particularly in elderly patients. These changes in renal function likely affect eligibility for adjuvant cisplatin-based therapy. Accordingly, we suggest strong consideration of neoadjuvant regimens.

Followup Interval Prostate Biopsy 3 Years After Diagnosis of High Grade Prostatic Intraepithelial Neoplasia is Associated With High Likelihood of Prostate Cancer, Independent of Change in Prostate Specific Antigen Levels

PURPOSE Repeat biopsy has been advocated following the diagnosis of high grade prostatic intraepithelial neoplasia to exclude coexisting prostate cancer. We further define the natural history of high grade prostatic intraepithelial neoplasia by determining the incidence of prostate cancer 3 years following diagnosis. MATERIALS AND METHODS A total of 31 men underwent followup interval biopsy 3 years after high grade prostatic intraepithelial neoplasia diagnosis in 1996 to 1997, regardless of change in serum prostate specific antigen (PSA) or digital rectal examination findings. A single pathologist reviewed all biopsy specimens. All men had a minimum of 12 biopsy cores taken at the time of diagnosis. RESULTS A 3-year followup interval biopsy eight (25.8%) men had prostate cancer, 11 (35.5%) had high grade prostatic intraepithelial neoplasia only and 12 (38.7%) had no disease. Mean serum PSA at diagnosis and before the followup biopsy was 6.88 and 9.69 ng./dl., respectively (p = 0.008). Of the men 48% had less than a 1.0 unit increase in serum PSA. Upon univariate regression analysis change in serum PSA was not associated with the detection of prostate cancer (p >0.10). All 4 patients who subsequently underwent radical prostatectomy had organ confined disease. CONCLUSIONS In a high proportion of men with high grade prostatic intraepithelial neoplasia prostate cancer will develop in a 3-year interval. Our findings support the concept that high grade prostatic intraepithelial neoplasia is a precursor to prostate cancer and that repeat biopsy at a delayed interval is recommended regardless of changes in PSA.

Optimization of Initial Prostate Biopsy in Clinical Practice: Sampling, Labeling and Specimen Processing

PURPOSE An optimal prostate biopsy in clinical practice is based on a balance among adequate detection of clinically significant prostate cancers (sensitivity), assuredness regarding the accuracy of negative sampling (negative predictive value), limited detection of clinically insignificant cancers and good concordance with whole gland surgical pathology results to allow accurate risk stratification and disease localization for treatment selection. Inherent within this optimization is variation of the core number, location, labeling and processing for pathological evaluation. To date, there is no consensus in this regard. The purpose of this review is to 1) define the optimal number and location of biopsy cores during primary prostate biopsy among men with suspected prostate cancer, 2) define the optimal method of labeling prostate biopsy cores for pathological processing which will provide relevant and necessary clinical information for all potential clinical scenarios, and 3) determine the maximal number of prostate biopsy cores allowable within a specimen jar which would not preclude accurate histological evaluation of the tissue. MATERIALS AND METHODS A bibliographic search using PubMed® covering the period up to July 2012 yielded approximately 550 articles. Articles were reviewed and categorized based on which of the 3 objectives of this review was addressed. Data were extracted, analyzed and summarized. Recommendations are provided based on this literature review and our clinical experience. RESULTS The use of 10 to 12-core extended sampling protocols increases cancer detection rates compared to traditional sextant sampling methods and reduces the likelihood of repeat biopsy by increasing negative predictive value, ultimately allowing more accurate risk stratification without increasing the likelihood of detecting insignificant cancers. As the number of cores increases above 12, the increase in diagnostic yield becomes marginal. Only limited evidence supports the use of initial biopsy schemes involving more than 12 cores or saturation. Apical and laterally directed sampling of the peripheral zone increases cancer detection rate, reduces the need for repeat biopsies and predicts pathological features on prostatectomy while transition zone biopsies do not. There are little data to suggest that knowing the exact site of an individual positive biopsy core provides meaningful clinical information. However, determining laterality of cancer on biopsy may be helpful for predicting sites of extracapsular extension and therapeutic planning. Placement of multiple biopsy cores in a single container (greater than 2) appears to compromise pathological evaluation, which can reduce cancer detection rate and increase the likelihood of equivocal diagnoses. CONCLUSIONS A 12-core systematic biopsy that incorporates apical and far-lateral cores in the template distribution allows maximal cancer detection, avoids repeat biopsy, and provides information adequate for identifying men who need therapy and planning that therapy while minimizing the detection of occult, indolent prostate cancers. This literature review does not provide compelling evidence that individual site specific labeling of cores benefits clinical decision making regarding the management of prostate cancer. Based on the available literature, we recommend packaging no more than 2 cores in each jar to avoid reduction of the cancer detection rate through inadequate tissue sampling.

Effect of Warm Ischemia Time During Laparoscopic Partial Nephrectomy on Early Postoperative Glomerular Filtration Rate

PURPOSE We evaluated the effect of warm ischemia time on early postoperative renal function following laparoscopic partial nephrectomy. MATERIALS AND METHODS Of 453 patients who were surgically treated for renal tumors between May 2001 and September 2007, and who were identified in our database 128 underwent laparoscopic partial nephrectomy. Of these 128 patients 101 who were evaluable had complete demographic, operative, preoperative and early postoperative data available. Renal function was estimated using the glomerular filtration rate. Warm ischemia time was stratified into 4 interval groups and also analyzed based on different time cutoffs. Ultimately we also tested the relationship between postoperative renal failure, and preoperative factors and warm ischemia time. RESULTS Warm ischemia time interval analysis was not significant. However, when analyzing the effect of warm ischemia time cutoffs, patients with warm ischemia time greater than 40 minutes had a significantly greater decrease in the glomerular filtration rate (p = 0.03) and a lower glomerular filtration rate postoperatively. The incidence of renal function impairment was more than 2-fold higher in those with a warm ischemia time of greater than 40 minutes than in the other groups (p = 0.077). Warm ischemia time was significant on univariate analysis when only patients with a preoperative glomerular filtration rate of 60 ml per minute per 1.73 m(2) or greater were analyzed. However, this did not hold as an independent predictor of postoperative renal function impairment on multivariate analysis. The preoperative glomerular filtration rate was the only independent predictor of postoperative renal function impairment. CONCLUSIONS A warm ischemia time of 40 minutes appears to be an appropriate cutoff, after which a significantly greater decrease in renal function occurs after laparoscopic partial nephrectomy. The preoperative glomerular filtration rate was the only independent predictor of an increased risk of renal insufficiency following laparoscopic partial nephrectomy.