Learning curve for fusion magnetic resonance imaging targeted prostate biopsy and three-dimensional transrectal ultrasonography segmentation.

OBJECTIVE: To report the learning curve of multiple operators for fusion magnetic resonance imaging (MRI) targeted biopsy and to determine the number of cases needed to achieve proficiency. MATERIALS AND METHODS: All adult males who underwent fusion MRI targeted biopsy between February 2012 and July 2021 for clinically suspected prostate cancer (PCa) in a single centre were included. Fusion transrectal MRI targeted biopsy was performed under local anaesthesia using the Koelis platform. Learning curves for segmentation of transrectal ultrasonography (TRUS) images and the overall MRI targeted biopsy procedure were estimated with locally weighted scatterplot smoothing by computing each operator's timestamps for consecutive procedures. Non-risk-adjusted cumulative sum (CUSUM) methods were used to create learning curves for clinically significant (i.e., International Society of Urological Pathology grade ≥ 2) PCa detection. RESULTS: Overall, 1721 patients underwent MRI targeted biopsy in our centre during the study period. The median (interquartile range) times for TRUS segmentation and for the MRI targeted biopsy procedure were 4.5 (3.5, 6.0) min and 13.2 (10.6, 16.9) min, respectively. Among the 14 operators with experience of more than 50 cases, a plateau was reached after 40 cases for TRUS segmentation time and 50 cases for overall MRI targeted biopsy procedure time. CUSUM analysis showed that the learning curve for clinically significant PCa detection required 25 to 45 procedures to achieve clinical proficiency. Pain scores ranged between 0 and 1 for 84% of patients, and a plateau phase was reached after 20 to 100 cases. CONCLUSIONS: A minimum of 50 cases of MRI targeted biopsy are necessary to achieve clinical and technical proficiency and to reach reproducibility in terms of timing, clinically significant PCa detection, and pain.

Role of Antimuscarinics Combined With Alpha-blockers in the Management of Urinary Storage Symptoms in Patients With Benign Prostatic Hyperplasia: An Updated Systematic Review and Meta-analysis.

PURPOSE: We evaluate the efficacy and safety of combining antimuscarinics with alpha-blockers to treat storage symptoms in men with benign prostatic hyperplasia. MATERIALS AND METHODS: Searches were carried out on PubMed, MEDLINE, EMBASE, and Cochrane databases to identify randomized, placebo-controlled trials published before February 15, 2022, assessing the efficacy or safety of antimuscarinics in men with benign prostatic hyperplasia treated with alpha-blockers. Further meta-analyses were performed using standardized mean difference and risk ratio. RESULTS: A total of 12 randomized trials were included in the systematic review. The meta-analysis showed no impact of antimuscarinics on the number of urgencies per day (SMD -0.23 [95%CI: -0.64; -0.17]; P = .21). However, the use of antimuscarinics was associated with a small reduction of micturition episodes per day (SMD -0.19 [95%CI: -0.37; -0.01]; P = .045). With regard to side effects, post-void residual increased slightly in patients treated with antimuscarinics (SMD 0.26 [95%CI: 0.15; 0.37]; P < .01). In addition, there was a higher risk of acute urinary retention (RR 3.26 [95%CI: 1.35; 7.86]; P = .02), dry mouth (RR 3.43 [95%CI: 1.86; 6.32]; P < .001), and constipation (RR 2.92 [95%CI: 1.48; 5.73]; P < .001) with the use of antimuscarinics. Finally, the risk of treatment interruption due to adverse events was higher for the patients treated with antimuscarinics (RR 1.74 [95%CI: 1.27; 2.38]; P < .01). CONCLUSIONS: The addition of antimuscarinics to alpha-blockers was not associated with a substantial reduction in urgencies and micturition episodes in benign prostatic hyperplasia patients with storage symptoms. In addition, the toxicity profile was not in favor of antimuscarinic use in these patients.

Robotic-assisted artificial urinary sphincter revisions for women suffering from non-neurogenic stress incontinence: a single center experience.

PURPOSE: Patients with artificial urinary eventually need surgical revision. Unfortunately, in women, this requires another invasive abdominal intervention. Robotic-assisted revision may provide a less invasive and more acceptable approach for sphincter revision in women. We wanted to determinate the continence status after robotic-assisted artificial urinary sphincter revision among women with stress incontinence. We also examined postoperative complications and the safety of the procedure. METHODS: The chart of the 31 women with stress urinary incontinence who underwent robotic-assisted AUS revision at our referral center from January 2015 to January 2022 were reviewed retrospectively. All patients underwent a robotic-assisted artificial urinary sphincter revision by one of our two expert surgeons. The primary outcome was to determinate the continence rate after revision and the secondary outcome aimed to evaluate the safety and feasibility of the procedure. RESULTS: Mean patients age was 65 years old, and the mean time between the sphincter revision and previous implantation was 98 months. After a mean follow-up of 35 months, 75% of the patients were fully continent (0-pad). Moreover, 71% of the women were back to the same continence status as with the previously functional sphincter, while 14% even have an improved continence status. Clavien-Dindo grade [Formula: see text] 3 and overall complications occurred in 9% and 20.5% of our patients, respectively. This study is mainly limited by its retrospective design. CONCLUSION: Robotic-assisted AUS revision carries satisfying outcome in terms of continence and safety.

Perioperative, renal function and oncological outcomes of robot-assisted radical nephroureterectomy for patients with upper tract urothelial carcinoma.

PURPOSE: To report perioperative, renal function and oncological outcomes of robot-assisted radical nephroureterectomy (RNU) for patients with upper tract urothelial carcinoma (UTUC). METHODS: This was a retrospective single-arm monocentric study including all consecutive UTUC patients treated with robot-assisted RNU at our institution between 2014 and 2022. Descriptive statistics with median and interquartile range (IQR) for continuous variables and numbers with frequencies for categorical variables were used to report perioperative and renal function outcomes while Kaplan-Meier curves were computed to present extravesical and intravesical recurrence-free survival(RFS) as well as cancer-specific (CSS) and overall survival (OS) with the corresponding 95% confidence intervals(CIs). RESULTS: Overall, 70 patients with a median age of 69.6 [63.3-74.9] years were included in our study. With regards to perioperative outcomes, the median operative time was 157 [130-182] min with a median blood loss of 200 [100-300] cc. Intraoperative complications occurred in 4 (5.7%) patients but no conversion to open or laparoscopic surgery was required. Postoperative complications occurred in 9 (12.9%) patients, including 5 (7.1%) with grade ≥ 3 complications according to the Clavien-Dindo classification. The median length of stay was 4 [3-6] days. With regards to renal function outcomes, the median postoperative loss in estimated glomerular filtration rate at discharge was 16 [10.25-26] mL/min/1.73 m2. With regards to oncological outcomes, the 3-year extravesical and intravesical RFS, CSS and OS rates were 73.6 [62.8-86.2]%, 68.1 [54.6-85]%, 82.5 [72-94.4]% and 75.3 [63.4-89.5]%, respectively. CONCLUSION: We report favorable perioperative and oncological outcomes with expected decrease in renal function after robot-assisted RNU for patients with UTUC.

Long-term device survival after a first implantation of AMS800™ for stress urinary incontinence: Comparison between men and women.

PURPOSE: The artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long-term device survival between women and men, after the first implantation of an AMS800™ artificial urinary sphincter (Boston Scientific) for the treatment of a non-neurogenic stress urinary incontinence. MATERIALS AND METHODS: This retrospective cohort study included all patients with nonneurogenic stress urinary incontinence who underwent surgery in a large-volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly a population with a history of radiotherapy and secondly a population with more than one previous surgery for urinary incontinence. RESULTS: A total of 107 women were matched to 316 men. Median follow-up was 6.0 years (Q1-Q3 1.8-9.4): 7.0 years (Q1-Q3 3.1-10.3) for women and 5.1 years (Q1-Q3 1.3-9.1) for men. During the follow-up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%), and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (hazard ratio 2.12 [1.29-3.48]). Before 6 months and after 8 years, there were no significant differences. Both sensitivity analyses found consistent results. CONCLUSIONS: This study suggests that device survival seems better in women after the first 6 months.

Dynamic evaluation of MRI-targeted, systematic and combined biopsy for prostate cancer diagnosis through 10 years of practice in a single institution.

PURPOSE: To perform a dynamic evaluation of the prostate cancer (PCa) detection rate according to the biopsy strategy over 10 years of practice in a single institution that pioneered MRI-targeted fusion biopsy (MRI-TB). METHODS: This stage 4 IDEAL study prospectively included all consecutive patients who underwent transrectal prostate biopsy for clinically suspected PCa between January 2010 and November 2020. Patients with positive MRI (PIRADS score ≥ 3) underwent both MRI-TB and systematic biopsy (SB) while those with negative MRI (PIRADS score < 3) underwent SB only. The main outcome was the evolution of the detection rate of clinically relevant PCa (csPCa; grade ≥ 2). The secondary outcome was the change in PCa detection rate according to the biopsy method. RESULTS: A total of 2942 men underwent prostate MRI and a prostate biopsy: 2322 underwent MRI-TB and 620 had SB only. The detection rate of csPCa increased 2.5-fold from 23 to 58%. The detection rate of PCa and csPCa was significantly higher in patients who underwent MRI-TB compared to those who underwent SB only (67% vs. 52% and 40% vs. 32%, respectively (P < 0.001 for both comparisons)). The number of csPCa diagnosed by MRI-TB increased linearly over the study period and represented the majority of PCa diagnoses after 2016. CONCLUSION: Implementation of MRI-TB in patients with positive MRI led to improved detection of csPCa.

Evaluation of the 24-h pad weight test as continence rate assessment tool after artificial urinary sphincter implantation for postprostatectomy urinary incontinence: A Swedish retrospective cohort study.

AIM: Patient-reported pad-count as continence rate assessment tool after artificial urinary sphincter (AUS) implantation is common. However, lack of standardized continence definition using this method results in heterogeneous published efficacy outcomes. Data on 24-h pad weight tests (PWT) after primary AUS implantation for postprostatectomy urinary incontinence (PPUI) is scarce. Our aim was to evaluate the 24-h PWT as an efficacy assessment tool and correlate it to qualitative outcomes using validated questionnaires. METHODS: This retrospective, single center, follow-up cohort study, evaluated 180 patients who underwent primary AUS implantation for PPUI from 2005 to 2018. Voiding diaries, 24-h PWT, validated patient satisfaction and quality of life (QoL) questionnaires were collected pre-operatively and at 3-6 months postactivation, using the institution's Electronic Medical Records. RESULTS: The median preoperative and postoperative 24-h PWT values were 494 (interquartile range [IQR]: 304-780) and 7 (IQR: 0-25) g respectively with a significant improvement in urinary leakage of 489.5 g 99.1% (p < 0.001). Median preoperative and postoperative I-QoL results increased from 33.5 (IQR: 19.3-63.6) to 86.4 (IQR: 73.9-94.3) points, with a significant 52.9 points improvement in QoL (p < 0.001). Similarly, the median preoperative and postoperative ICIQ-SF values decreased from 20 (IQR: 17-21) to 5 (IQR: 3-9) points, showing a significant improvement of 15 points (p < 0.001). We also found a significant correlation between PWT and patient satisfaction. CONCLUSION: The 24-h PWT provides a reliable and objective assessment of continence rates, with a strong correlation to qualitative outcomes, after primary AUS implantation for PPUI. Its use could help reduce reported outcome heterogeneity across studies.

Satisfaction and surgical outcomes in patients undergoing penile prosthesis implantation for drug-refractory erectile dysfunction: mid-term results in a single center French cohort.

INTRODUCTION: To investigate the mid-term results of penile prosthesis (PP) implantation in patients with erectile dysfunction (ED) from a "real-life" historic cohort in a French academic center. MATERIALS AND METHODS: All patients receiving an inflatable PP between 2004 and 2014 in our institution were included in this study. ED was assessed preoperatively using the IEEF-5 questionnaire. Postoperative satisfaction with the PP was assessed using the EDITS questionnaire at each follow up visit. Postoperative complications were classed according to the Clavien classification. Surgical and functional outcomes were recorded prospectively. RESULTS: Seventy-six men received a PP during the 10 year study period. Median (IQR) age was 62 (58-69) years. The main causes of ED were radical prostatectomy (n = 40; 53%) and diabetes mellitus (n = 28; 36.8%). Five patients (6.6%) had a non-functioning PP in place requiring complete substitution or a previous penile implant which had already been removed at the time of surgery. Sixty-nine (90.8%) patients received an AMS 700 CX device and seven (9.2%) a Coloplast Titan. The surgical approach was penoscrotal in 45 (59.2%) and infrapubic in 31 (40.8%). Intraoperative complications occurred in four (5%) patients, without compromising the intervention. Postoperative complications occurred in 27 (35.5%) patients: 17 (22%) were Clavien I-II and 10 (15%) Clavien III. All major complications resulted in prosthesis removal (n = 9; 11.8%) or revision (n = 1; 1.3%). Median (IQR) follow up was 43 (34-55) months. At the end of follow up, 70 (92.1%) patients had a functional implant. Fifty-four (71.1%) patients were satisfied with the device at the 6 month follow up visit and beyond. Early satisfaction (at 3 months) was reported by 44 (57.9%) patients. A previous PP was the only significant risk factor for prosthesis removal (p = 0.001). CONCLUSION: PP implantation is a safe and satisfactory treatment for ED. However, patient selection remains crucial in determining the post-surgical success of this procedure.

Dynamic contrast-enhanced imaging in localizing local recurrence of prostate cancer after radiotherapy: Limited added value for readers of varying level of experience.

BACKGROUND: The incremental value of dynamic contrast-enhanced (DCE) imaging in localizing radiorecurrent prostate cancer is uncertain. PURPOSE: To assess the added-value of DCE imaging to the combination T2 -weighted imaging (T2 W)+diffusion-weighted imaging (DWI) in detecting locally radiorecurrent prostate cancer (PCa), by radiologists with different levels of experience. STUDY TYPE: Analytic retrospective study. POPULATION: In all, 52 men with biological suspected PCa recurrence after radiotherapy were retrospectively included. FIELD STRENGTH/SEQUENCE: All men underwent prostatic MRI (1.5T or 3T), including T2 W, DWI, and DCE imagings, before biopsies. ASSESSMENT: Two junior (6 months' experience) and two senior readers (more than 3 years' experience) independently assigned a Likert score for each prostatic sextant on T2 W+DW+DCE imagings, then on T2 W+DW imagings, 4 weeks later. STATISTICAL TESTS: The reference standard was prostatic biopsies. For two levels of positivity of Likert score, 3/5 and 4/5, sensitivity, specificity, area under the receiver operating curve (AUC), and interreader agreement were compared. RESULTS: T2 W+DWI+DCE and T2 W+DWI imaging had similar AUC at lobe and sextant level (0.853-0.946 vs. 0.819-0.955, P from 0.071-0.534). Using a Likert score ≥4/5, T2 W+DWI+DCE significantly improved the sensitivity for junior readers at the patient, lobe, and sextant level (40-80% vs. 22-66%, P < 0.0001-0.041). Sensitivity was not significantly modified with DCE imaging for senior readers (54-95% vs. 50-91%, P from 0.074-1). Specificity was not modified for all readers (50-100% vs. 50%-100%, P from 0.134-1). DCE imaging improved interreader agreement for a Likert score ≥4/5 (kappa from 0.6-0.73 vs. 0.38-0.73). DATA CONCLUSION: The addition of DCE imaging did not significantly improve accuracy in recurrent PCa detection after radiotherapy, whatever the level of experience of the readers. However, the addition of DCE imaging slightly improved the sensitivity for less-experienced readers and increased their diagnostic confidence. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018;48:1012-1023.

Multiparametric MRI for Suspected Recurrent Prostate Cancer after HIFU:Is DCE still needed?

PURPOSE: To assess the added value of the dynamic contrast-enhanced sequence (DCE) to combination T2-weighted imaging (T2w) + diffusion-weighted imaging (DWI) in detecting prostate cancer (PCa) recurrence after HIFU (high-intensity focused ultrasound). METHODS: Forty-five males with clinical and biological suspected PCa recurrence were retrospectively selected. All underwent multi-parametric MRI (mpMRI) before biopsies. Two readers independently assigned a Likert score of cancer likelihood on T2w + DWI + DCE and T2w + DWI images. Prostatic biopsies were taken as the gold standard. RESULTS: Recurrent PCa was identified at biopsy for 37 patients (82%). Areas under the receiver-operating curve of T2w + DWI and T2w + DWI + DCE imaging were not significantly different for both readers. Using a Likert score ≥ 3 for the PCa diagnosis threshold, sensitivity at the lobe level for the (1) senior and (2) junior reader for T2w +DWI +DCE sensitivity was (1) 0.97 and (2) 0.94 vs. (1) 0.94 and (2) 0.97 for T2w + DWI. CONCLUSION: Accuracy of mpMRI was not significantly improved by adding DCE to T2w + DWI. Sensitivity was high for T2w + DWI + DCE and T2w + DWI with no significant difference for either the junior or senior reader. KEY POINTS: • MpMRI has the capability to detect PCa recurrence in post-HIFU monitoring. • The sensitivity of T2w and DWI for detecting PCa recurrence was not improved by DCE. • Readers with different degrees of experience did not improve their performance with DCE.

Accuracy of elastic fusion biopsy in daily practice: Results of a multicenter study of 2115 patients.

OBJECTIVES: To assess the accuracy of Koelis fusion biopsy for the detection of prostate cancer and clinically significant prostate cancer in the everyday practice. METHODS: We retrospectively enrolled 2115 patients from 15 institutions in four European countries undergoing transrectal Koelis fusion biopsy from 2010 to 2017. A variable number of target (usually 2-4) and random cores (usually 10-14) were carried out, depending on the clinical case and institution habits. The overall and clinically significant prostate cancer detection rates were assessed, evaluating the diagnostic role of additional random biopsies. The cancer detection rate was correlated to multiparametric magnetic resonance imaging features and clinical variables. RESULTS: The mean number of targeted and random cores taken were 3.9 (standard deviation 2.1) and 10.5 (standard deviation 5.0), respectively. The cancer detection rate of Koelis biopsies was 58% for all cancers and 43% for clinically significant prostate cancer. The performance of additional, random cores improved the cancer detection rate of 13% for all cancers (P < 0.001) and 9% for clinically significant prostate cancer (P < 0.001). Prostate cancer was detected in 31%, 66% and 89% of patients with lesions scored as Prostate Imaging Reporting and Data System 3, 4 and 5, respectively. Clinical stage and Prostate Imaging Reporting and Data System score were predictors of prostate cancer detection in multivariate analyses. Prostate-specific antigen was associated with prostate cancer detection only for clinically significant prostate cancer. CONCLUSIONS: Koelis fusion biopsy offers a good cancer detection rate, which is increased in patients with a high Prostate Imaging Reporting and Data System score and clinical stage. The performance of additional, random cores seems unavoidable for correct sampling. In our experience, the Prostate Imaging Reporting and Data System score and clinical stage are predictors of prostate cancer and clinically significant prostate cancer detection; prostate-specific antigen is associated only with clinically significant prostate cancer detection, and a higher number of biopsy cores are not associated with a higher cancer detection rate.

Stress urinary incontinence in female neurological patients: long-term functional outcomes after artificial urinary sphincter (AMS 800TM ) implantation.

AIMS: To report the long-term functional outcomes of artificial urinary sphincter (AUS) implantation in female adult neurological patients suffering from stress urinary incontinence (SUI) due to sphincter deficiency. METHODS: Female patients with neurological disease suffering from SUI due to sphincter deficiency who underwent AUS (AMS 800TM ) implantation between 1984 and 2011 were included. Continence rate defined as no need for pads and survival rates of the device without needing explantation or revision using Kaplan-Meier curves were reported. RESULTS: Overall, 26 patients, median age 49.2 years (IQR 28.5-59.7) were included. The median follow-up time was 7.5 years (IQR 3.9-23.8). At the end of follow-up period, 15 patients (57.7%) still had their primary AUS. The AUS was explanted in five women because of infection or erosion. Survival rates, without AUS explantation were 90%, 84%, 84%, and 74% at 5, 10, 15, 20 years, respectively. Survival rates without AUS revision were 75%, 51%, 51%, and 51% at 5, 10, 15, 20 years, respectively. 71.4% of patients with AUS were continent. When considering the 26 initial patients, including the patients in whom the AUS was explanted, the continence rate was 57.7%. CONCLUSIONS: For treating neurogenic sphincter deficiency in the long term, the AMS 800TM can offer a satisfying rate of continence to female patients, with a tolerable rate of explantation and revision. Neurourol. Urodynam. 36:764-769, 2017. © 2016 Wiley Periodicals, Inc.

Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer?

PURPOSE: In men with suspicion of prostate cancer the standard of cancer detection is transrectal ultrasound guided 10 to 12-core systematic biopsy. The targeted biopsy only strategy using magnetic resonance imaging-transrectal ultrasound image registration is gaining in popularity. We assessed the noninferiority of targeted vs systematic biopsy. MATERIALS AND METHODS: Between June and October 2014 a total of 108 biopsy naïve patients with prostate specific antigen between 4 and 20 ng/ml, normal rectal examination and a single suspicious image on magnetic resonance imaging were included in study at 7 centers. Patients underwent systematic biopsy by a first operator blinded to magnetic resonance imaging, immediately followed by 3 targeted biopsies within the suspicious image by a second operator. The primary end point was the cancer detection rate. The noninferiority margin was set at -5%. The secondary end points were the detection rate of clinically significant prostate cancer (maximum cancer core length 5 mm or greater for Gleason 6 or any Gleason 7 or greater disease) and procedure duration. RESULTS: Systematic and targeted biopsies detected cancer in 66 (61.1%) and 61 patients (56.5%), respectively. The mean difference was -4.5% with a 95% CI lower bound of -11.8%. A total of 13 patients with protocol violations were excluded from the per protocol analysis, which showed a mean difference of -5.2% with a 95% CI lower bound of -13.1%. Clinically significant prostate cancer was detected in 50 (46.2%) and 52 patients (48.1%) with systematic and targeted biopsies, respectively (p = 0.69). The mean ± SD duration of image fusion plus targeted biopsy was 16.7 ± 7 minutes vs 7.4 ± 3 for systematic biopsy (p <0.001). CONCLUSIONS: Targeted biopsy seemed to be inferior to systematic biopsy for overall cancer detection. Detection of clinically significant prostate cancer did not differ between targeted and systematic biopsies.

Relationship between non-suspicious MRI and insignificant prostate cancer: results from a monocentric study.

OBJECTIVES: To assess whether non-suspicious multiparametric magnetic-resonance imaging (mpMRI) was associated with no cancer or indolent prostate cancer (PCa) in subsequent biopsies. PATIENTS AND METHODS: Retrospective analyses of a prospective database were conducted between 2009 and 2013. It included men with an abnormal digital rectal examination and/or prostate-specific antigen levels <20 ng/mL and a non-suspicious multiparametric MRI (Likert score <3). Participants underwent a systematic 12-extended-core biopsy ultrasound protocol (STD). Indolent PCa was defined as a single core with a Gleason score of 6 (3 + 3) and a cancer-core length of ≤4 mm. RESULTS: Seventy-eight patients with a negative MRI were included in the study; median patient age was 62 years (IQR 50-74). Median PSA level was 7.15 ng/mL, with a median PSA density of 0.15. The digital rectal examination was abnormal in eight cases. From MRI, 53 patients were Likert 2, 25 patients were Likert 1, and median prostate volume was 56.5 mL. From biopsies, no cancer was found in 92.3 % (n = 72). PCa was histologically confirmed in six patients (7.7 %): five cases were indolent (as defined above); only one patient had a cancer core of 5 mm long, with a Gleason score of 6 (3 + 3). All six patients were within the low-risk group according to the D'Amico classification. CONCLUSION: Men with non-suspicious mpMRI are likely to have no or indolent PCa in subsequent biopsies.

Apparent diffusion coefficient value is a strong predictor of unsuspected aggressiveness of prostate cancer before radical prostatectomy.

PURPOSE: To evaluate the use of multiparametric MRI (mp MRI) parameters in order to predict prostate cancer aggressiveness as defined by pathological Gleason score or molecular markers in a cohort of patients defined with a Gleason score of 6 at biopsy. METHODS: Sixty-seven men treated by radical prostatectomy (RP) for a low grade (Gleason 6) on biopsy and mp MRI before biopsy were selected. The cycle cell proliferation (CCP) score assessed by the Prolaris test and Ki-67/PTEN expression assessed by immunohistochemistry were quantified on the RP specimens. RESULTS: 49.25 % of the cancers were undergraded on biopsy compared to the RP specimens. Apparent diffusion coefficient (ADC) < 0.80 × 10(-3) mm(2)/s (P value 0.003), Likert score >4 (P value 0.003) and PSA density >0.15 ng/ml/cc (P value 0.035) were significantly associated with a higher RP Gleason score. Regarding molecular markers of aggressiveness, ADC < 0.80 × 10(-3) mm(2)/s and Likert score >4 were also significantly associated with a positive staining for Ki-67 (P value 0.039 and 0.01, respectively). No association was found between any analyzed MRI or clinical parameter and the CCP score. CONCLUSION: Decreasing ADC value is a stronger indicator of aggressive prostate cancer as defined by molecular markers or postsurgical histology than biopsy characteristics.

Accuracy of the prostate health index versus the urinary prostate cancer antigen 3 score to predict overall and significant prostate cancer at initial biopsy.

BACKGROUND: It remains unclear whether the Prostate Health Index (PHI) or the urinary Prostate-Cancer Antigen 3 (PCA-3) score is more accurate at screening for prostate cancer (PCa). The aim of this study was to prospectively compare the accuracy of PHI and PCA-3 scores to predict overall and significant PCa in men undergoing an initial prostate biopsy. METHODS: Double-blind assessments of PHI and PCA-3 were conducted by referent physicians in 138 patients who subsequently underwent trans-rectal ultrasound-guided prostate biopsy according to a 12-core scheme. Predictive accuracies of PHI and PCA-3 were assessed using AUC and compared according to the DeLong method. Diagnostic performances with usual cut-off values for positivity (i.e., PHI >40 and PCA-3 >35) were calculated, and odds ratios associated with predicting PCa overall and significant PCa as defined by pathological updated Epstein criteria (i.e., Gleason score ≥7, more than three positive cores, or >50% cancer involvement in any core) were estimated using logistic regression. RESULTS: Prevalences of overall and significant PCa were 44.9% and 28.3%, respectively. PCA-3 (AUC = 0.71) was the most accurate predictor of PCa overall, and significantly outperformed PHI (AUC = 0.65; P = 0.03). However, PHI (AUC = 0.80) remained the most accurate predictor when screening exclusively for significant PCa and significantly outperformed PCA-3 (AUC = 0.55; P = 0.03). Furthermore, PCA-3 >35 had the best accuracy, and positive or negative predictive values when screening for PCa overall whereas these diagnostic performances were greater for PHI >40 when exclusively screening for significant PCa. PHI > 40 combined with PCA-3 > 35 was more specific in both cases. In multivariate analyses, PCA-3 >35 (OR = 5.68; 95%CI = [2.21-14.59]; P < 0.001) was significantly correlated with the presence of PCa overall, but PHI >40 (OR = 9.60; 95%CI = [1.72-91.32]; P = 0.001) was the only independent predictor for detecting significant PCa. CONCLUSIONS: Although PCA-3 score is the best predictor for PCa overall at initial biopsy, our findings strongly indicate that PHI should be used for population-based screening to avoid over-diagnosis of indolent tumors that are unlikely to cause death.

Prostate Imaging Reporting and Data System and Likert Scoring System: Multiparametric MR Imaging Validation Study to Screen Patients for Initial Biopsy.

PURPOSE: To compare the diagnostic performance of the magnetic resonance (MR) imaging-based Prostate Imaging Reporting and Data System (PI-RADS) and a Likert scale in the detection of prostate cancer in a cohort of patients undergoing initial prostate biopsy. MATERIALS AND METHODS: This institutional review board-approved two-center prospective study included 118 patients with normal digital rectal examination (DRE) results but elevated prostate-specific antigen (PSA) levels (4-20 ng/mL) who were referred for initial prostate biopsies and had one suspicious (Likert scale score, ≥3) focus at prebiopsy 1.5-T multiparametric MR imaging performed with T2-weighted, diffusion-weighted [DW], and dynamic contrast material-enhanced imaging. Targeted core biopsies and random systematic core biopsies were performed. The elementary unit for analysis was the core. Relationships were assessed by using the Mann-Whitney U test. Yates corrected and Pearson χ(2) tests were used to evaluate categoric variables. A training set was randomly drawn to construct the receiver operating characteristic curves for the summed PI-RADS scores and for the Likert scale scores. The thresholds to recommend biopsy were obtained from the Youden J statistics and were tested in the remaining validation set in terms of predictive characteristics. Interobserver variability was analyzed by using weighed κ statistics in a random set of 50 patients. RESULTS: Higher T2-weighted, DW, and dynamic contrast-enhanced imaging PI-RADS scores were observed in areas that yielded cancer-positive cores. The percentage of positive cores increased with the sum of scores aggregated in five classes as follows: For summed PI-RADS scores of 3-5, the percentage of positive cores was 2.3%; for scores of 6-8, it was 5.8%; for scores of 9 or 10, it was 24.7%; for scores of 11 or 12, it was 51.8%; and for scores of 13-15, it was 72.1% (P for trend, <.0001). For the threshold of summed PI-RADS scores of 9 or greater, sensitivity was 86.6%, specificity was 82.4%, the positive predictive value was 52.4%, the negative predictive value was 96.5%, and accuracy was 83.2%. The respective data for Likert scale scores of 3 or greater were 93.8%, 73.6%, 44.3%, 98.1%, and 73.3%. Good interobserver agreement was observed for the Likert scale (κ = 0.80) and the summed PI-RADS (κ = 0.73) scoring systems. CONCLUSION: PI-RADS provided the site-specific stratified risk of cancer-positive cores in biopsy-naive men with normal DRE results and elevated PSA levels. There was no significant difference between summed PI-RADS scores of 9 or greater and Likert scale scores of 3 or greater in the detection of cancer in the peripheral zone.

Magnetic Resonance Imaging Targeted Biopsy Improves Selection of Patients Considered for Active Surveillance for Clinically Low Risk Prostate Cancer Based on Systematic Biopsies.

PURPOSE: Current selection criteria for active surveillance based on systematic biopsy underestimate prostate cancer volume and grade. We investigated the role of additional magnetic resonance imaging targeted biopsy in reclassifying patients eligible for active surveillance based on systematic biopsy. MATERIALS AND METHODS: We performed a study at 2 institutions in a total of 281 men with increased prostate specific antigen. All men met certain criteria, including 1) prebiopsy magnetic resonance imaging, 12-core transrectal systematic biopsy and 2 additional magnetic resonance imaging targeted biopsies of lesions suspicious for cancer during the same sequence as systematic biopsy, and 2) eligibility for active surveillance based on systematic biopsy results. Criteria for active surveillance were prostate specific antigen less than 10 ng/ml, no Gleason grade 4/5, 5 mm or less involvement of any biopsy core and 2 or fewer positive systematic biopsy cores. Patient characteristics were compared between reclassified and nonreclassified groups based on magnetic resonance imaging targeted biopsy results. RESULTS: On magnetic resonance imaging 58% of the 281 patients had suspicious lesions. Magnetic resonance imaging targeted biopsy was positive for cancer in 81 of 163 patients (50%). Of 281 patients 28 (10%) were reclassified by magnetic resonance imaging targeted biopsy as ineligible for active surveillance based on Gleason score in 8, cancer length in 20 and Gleason score plus cancer length in 9. Suspicious areas on magnetic resonance imaging were in the anterior part of the prostate in 15 of the 28 men (54%). Reclassified patients had a smaller prostate volume (37 vs 52 cc) and were older (66.5 vs 63 years) than those who were not reclassified (p < 0.05). CONCLUSIONS: Magnetic resonance imaging targeted biopsy reclassified 10% of patients who were eligible for active surveillance based on systematic biopsy. Its incorporation into the active surveillance eligibility criteria may decrease the risk of reclassification to higher stages during followup.

Multiparametric Magnetic Resonance Imaging Predicts Postoperative Pathology but Misses Aggressive Prostate Cancers as Assessed by Cell Cycle Progression Score.

PURPOSE: We identified prognostic biomarkers in prostate cancer by a radiogenomics strategy that integrates gene expression using the cell cycle progression score and medical images. MATERIALS AND METHODS: We obtained institutional review board approval and written informed consent from 106 men with prostate cancer, including 60% at low risk, who underwent multiparametric magnetic resonance imaging before radical prostatectomy was done and a cell cycle progression score was determined. The correlation between the results of multiparametric magnetic resonance imaging and Gleason grade or cell cycle progression score was assessed by logistic regression. RESULTS: Patients with primary Gleason grade greater than 3 had a longer median maximal tumor diameter (13 vs 10 mm) and a lower median apparent diffusion coefficient (0.745 vs 0.88×10(-3) mm2 per second, each p=0.0001) than those with primary Gleason grade 3 or less. Maximal diameter 10 mm or greater (OR 4.9, 95% CI 1.7 to 14.0, p=0.0012) and apparent diffusion coefficient 0.80×10(-3) mm2 per second or less (OR 7.5, 95% CI 3.0 to 18.7, p<0.0001) were significantly associated with primary Gleason grade greater than 3. The combined measure of maximal diameter less than 10 mm and apparent diffusion coefficient greater than 0.80×10(-3) mm2 per second identified only index lesions harboring primary Gleason grade 3. However, 7 of those lesions showed a molecular pattern of high risk lethal prostate cancer (cell cycle progression score greater than 0). CONCLUSIONS: Multiparametric magnetic resonance imaging is able to predict low and high risk Gleason scores in the tumor. However, the cell cycle progression score did not completely match the imaging result. These findings suggest that management of early stages prostate cancer could strongly benefit by performing magnetic resonance imaging targeted biopsy coupled with molecular analysis.