Robert Rabenalt

Prospective Randomized Trial Comparing Magnetic Resonance Imaging (MRI)-guided In-bore Biopsy to MRI-ultrasound Fusion and Transrectal Ultrasound-guided Prostate Biopsy in Patients with Prior Negative Biopsies

BACKGROUND A significant proportion of prostate cancers (PCas) are missed by conventional transrectal ultrasound-guided biopsy (TRUS-GB). It remains unclear whether the combined approach using targeted magnetic resonance imaging (MRI)-ultrasound fusion-guided biopsy (FUS-GB) and systematic TRUS-GB is superior to targeted MRI-guided in-bore biopsy (IB-GB) for PCa detection. OBJECTIVE To compare PCa detection between IB-GB alone and FUS-GB + TRUS-GB in patients with at least one negative TRUS-GB and prostate-specific antigen ≥4 ng/ml. DESIGN, SETTING, AND PARTICIPANTS Patients were prospectively randomized after multiparametric prostate MRI to IB-GB (arm A) or FUS-GB + TRUS-GB (arm B) from November 2011 to July 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The study was powered at 80% to demonstrate an overall PCa detection rate of ≥60% in arm B compared to 40% in arm A. Secondary endpoints were the distribution of highest Gleason scores, the rate of detection of significant PCa (Gleason ≥7), the number of biopsy cores to detect one (significant) PCa, the positivity rate for biopsy cores, and tumor involvement per biopsy core. RESULTS AND LIMITATIONS The study was halted after interim analysis because the primary endpoint was not met. The trial enrolled 267 patients, of whom 210 were analyzed (106 randomized to arm A and 104 to arm B). PCa detection was 37% in arm A and 39% in arm B (95% confidence interval for difference, -16% to 11%; p=0.7). Detection rates for significant PCa (29% vs 32%; p=0.7) and the highest percentage tumor involvement per biopsy core (48% vs 42%; p=0.4) were similar between the arms. The mean number of cores was 5.6 versus 17 (p<0.001). A limitation is the limited number of patients because of early cessation of accrual. CONCLUSIONS This trial failed to identify an important improvement in detection rate for the combined biopsy approach over MRI-targeted biopsy alone. A prospective comparison between MRI-targeted biopsy alone and systematic TRUS-GB is justified. PATIENT SUMMARY Our randomized study showed similar prostate cancer detection rates between targeted prostate biopsy guided by magnetic resonance imaging and the combination of targeted biopsy and systematic transrectal ultrasound-guided prostate biopsy. An important improvement in detection rates using the combined biopsy approach can be excluded.

Increased signal intensity of prostate lesions on high b-value diffusion-weighted images as a predictive sign of malignancy

AbstractObjectivesThe evaluation of lesions detected in prostate magnetic resonance imaging (MRI) with increased signal intensity (SI) on high b-value diffusion-weighted images as a sign of malignancy.MethodsOne hundred and three consecutive patients with prostate MRI examination and MRI-guided in-bore biopsy were retrospectively included in the study. MRI-guided in-bore biopsy histologically confirmed prostate cancer in 50 patients (n = 92 lesions). The other 53 patients (n = 122 lesions) had negative bioptical results.ResultsIn patients with histologically confirmed prostate cancer, 46 of the 92 lesions had visually increased SI on the high b-value images compared with the peripheral zone (SI = +27 ± 16%) or the central gland (SI = +37 ± 19%, P < 0.001 respectively). In patients with a negative biopsy, ten of the 122 lesions had visually increased SI (compared with the peripheral zone, SI = +29 ± 18%, and with the central gland, SI = +41 ± 15%, P < 0.001 respectively). Neither the apparent diffusion coefficient (ADC) values nor the Gleason Score of lesions with increased SI were significantly different from lesions without increased SI.ConclusionsVisually increased SI on the high b-value images of diffusion-weighted imaging using standard b-values is a sign of malignancy but can occasionally also be a feature of benign lesions. However, it does not indicate more aggressive tumours.Key points• Diffusion weighted magnetic resonance imaging is increasingly used to diagnose prostatic cancer • Reduced signal intensity (SI) on apparent diffusion coefficient (ADC) mapping is characteristic • Prostatic tumours usually exhibit increased SI on high b-value images • But benign lesions can also yield increased SI on high b-value images

[Standardised scoring of a multi-parametric 3-T MRI for a targeted MRI-guided prostate biopsy].

BACKGROUND The use of multi-parametric MRI and MRI-guided biopsy for the detection of prostate cancer is rapidly increasing. This is a pilot study to evaluate the consensus-based international MRI scoring system as decision criterion for targeted MRI-guided prostate biopsy. MATERIAL AND METHODS After a multi-parametric 3-T MRI (T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced MRI) in 23 consecutive patients a total of 47 lesions were scored according to a 5-point scale for each MRI sequence. A total score of ≥ 10 points was considered to be suspicious for prostate cancer. All 47 lesions were histologically assessed after MRI-guided biopsy. RESULTS At the cut-off score of 10 points, sensitivity, specificity, negative predictive value and positive predictive value of multi-parametric MRI were 94.1, 43.3, 92.9 and 48.5%, respectively. CONCLUSIONS A standardised scoring of lesions on multi-parametric MRI is feasible. The cut-off value leads to excellent values for sensitivity and negative predictive value. The values for specificity and positive predictive value are modest. Lesions with a total score <10 points are very unlikely to be malignant.

3-T in-bore MR-guided prostate biopsy based on a scoring system for target lesions characterization.

Background To estimate potential malignant lesions within the prostate gland, the usage of a scoring system has recently been proposed by a European consensus meeting. Purpose To prospectively investigate a scoring system for functional prostate magnetic resonance imaging (MRI) using in-bore MR-guided prostate biopsy at 3-T. Material and Methods Prostate MRI examinations of 59 patients (between February 2011 and May 2012) with no known prostate cancer, elevated prostate specific antigen (PSA) level, and unsuspicious digital rectal examination were included in the study. In each patient up to three lesions were defined and scored using a 5-point scoring system for each MR sequence (T2-weighted images, diffusion-weighted imaging, dynamic contrast-enhanced imaging). Following MRI-guided in-bore biopsy these lesions were correlated to the histopathological findings. Results A total number of 144 lesions were defined in 59 patients. In 28 patients (51 lesions) MR-guided in-bore biopsy was positive for tumor (Gleason grade 6 or higher). A cut-off limit of 10 or more points in summation of the individual scores of all three sequences was used, leading to a 90% sensitivity, 63% specificity, 58% positive predictive value, and 92% negative predictive value. Conclusion A simple 5-point scoring system of functional prostate MRI achieves excellent sensitivity and moderate specificity for directing 3-T-guided prostate biopsy relative to the histopathological findings.

Standardisierung des multiparametrischen 3-T-MRT zur zielgerichteten Biopsie der Prostata

BACKGROUND The use of multi-parametric MRI and MRI-guided biopsy for the detection of prostate cancer is rapidly increasing. This is a pilot study to evaluate the consensus-based international MRI scoring system as decision criterion for targeted MRI-guided prostate biopsy. MATERIAL AND METHODS After a multi-parametric 3-T MRI (T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced MRI) in 23 consecutive patients a total of 47 lesions were scored according to a 5-point scale for each MRI sequence. A total score of ≥ 10 points was considered to be suspicious for prostate cancer. All 47 lesions were histologically assessed after MRI-guided biopsy. RESULTS At the cut-off score of 10 points, sensitivity, specificity, negative predictive value and positive predictive value of multi-parametric MRI were 94.1, 43.3, 92.9 and 48.5%, respectively. CONCLUSIONS A standardised scoring of lesions on multi-parametric MRI is feasible. The cut-off value leads to excellent values for sensitivity and negative predictive value. The values for specificity and positive predictive value are modest. Lesions with a total score <10 points are very unlikely to be malignant.

[Robot-assisted radical cystectomy. Pilot study for the prospective evaluation of perioperative parameters compared to open radical cystectomy].

BACKGROUND For robot-assisted radical cystectomy prospective assembly and evaluation of peri- and postoperative parameters within a national database is planned. This pilot study evaluated which parameters should be assessed and which problems might occur for assembly and interpretation of data. PATIENTS AND METHODS Of 84 patients with radical cystectomy, 14 underwent RARC. Evaluable patients were compared to patients with open radical cystectomy (ORC) regarding perioperative parameters. In addition, a literature review on published single-center RARC series and comparative investigations (RARC vs ORC) was performed. Published data were compared to results of our own series. RESULTS RARC patients received less packed red blood cells [RARC: 0 (0-2), ORC 2 (0-12), p=0.009] and hospitalization was shorter [RARC: 14 (8-18) days, ORC: 18 (11-97) days, p=0.015]. Comorbidities as assessed by the Charlson Comorbidity Index were less common in RARC patients [RARC: 4 (3-8), ORC: 6 (3-11), p=0.11]. No major differences between our own and published results were observed. The rate of continent urinary diversions in the Düsseldorf RARC cohort was, apart from one study, larger. Problems in the assembly and interpretation of operation time, blood loss, transfusion rate, and postoperative recovery were observed. CONCLUSIONS Even in this small cohort results of published studies were confirmed. Potential problems in data assembly were identified. Appropriate solutions will be implemented in the national database.

Current second-line treatment options for patients with castration resistant prostate cancer (CRPC) resistant to docetaxel

Chemotherapy with docetaxel remains the standard first-line treatment in patients with castration-resistant prostate cancer (CRPC). To date there is no recommended second-line therapy in case of progression after docetaxel treatment. Knowledge of the molecular and cellular changes that occur during the transition of hormone-native to CRPC is increasing rapidly opening new therapy strategies in CRPC patients. This article will focus on recent available therapy options for patients with progressive CRPC after first-line treatment with docetaxel and highlights promising novel substances that are currently under investigation.

Roboterassistierte radikale Zystektomie

BACKGROUND For robot-assisted radical cystectomy prospective assembly and evaluation of peri- and postoperative parameters within a national database is planned. This pilot study evaluated which parameters should be assessed and which problems might occur for assembly and interpretation of data. PATIENTS AND METHODS Of 84 patients with radical cystectomy, 14 underwent RARC. Evaluable patients were compared to patients with open radical cystectomy (ORC) regarding perioperative parameters. In addition, a literature review on published single-center RARC series and comparative investigations (RARC vs ORC) was performed. Published data were compared to results of our own series. RESULTS RARC patients received less packed red blood cells [RARC: 0 (0-2), ORC 2 (0-12), p=0.009] and hospitalization was shorter [RARC: 14 (8-18) days, ORC: 18 (11-97) days, p=0.015]. Comorbidities as assessed by the Charlson Comorbidity Index were less common in RARC patients [RARC: 4 (3-8), ORC: 6 (3-11), p=0.11]. No major differences between our own and published results were observed. The rate of continent urinary diversions in the Düsseldorf RARC cohort was, apart from one study, larger. Problems in the assembly and interpretation of operation time, blood loss, transfusion rate, and postoperative recovery were observed. CONCLUSIONS Even in this small cohort results of published studies were confirmed. Potential problems in data assembly were identified. Appropriate solutions will be implemented in the national database.

Retrograde balloon dilation >10 weeks after renal transplantation for transplant ureter stenosis - our experience and review of the literature.

Abstract Objective: Despite many efforts to prevent ureteric stenosis in a transplanted kidney, this complication occurs in 3–5% of renal transplant recipients. Balloon dilatation (BD) is a possible minimally invasive approach for treatment, but reports to date refer only to the antegrade approach; we analysed our experience with retrograde BD (RBD) and reviewed previous reports. Patients and methods: From October 2008 to February 2011, eight patients after renal transplantation (RTX) underwent RBD for transplant ureteric stenosis at our hospital. We retrospectively analysed the outcome and reviewed previous reports. Results: The eight recipients (five men and three women; median age 55 years, range 38–69) were treated with one or two RBDs for transplant ureteric stenosis. There were no complications. The median (range) time after RTX was 4.5 (2.5–11) months. Long-term success was only achieved in one recipient, while five patients were re-operated on (three with a new implant, two by replacement of transplanted ureter with ileum) after a median (range) of 2.8 (0.7–7.0) months after unsuccessful RBD(s). For two recipients the success remained unclear (one graft loss due to other reasons, one result pending). When the first RBD was unsuccessful there was no improvement with a second. Conclusions: RBD is technically feasible, but our findings and the review of previous reports on antegrade ureteric dilatation suggest that the success rate is low when the ureter is dilated at ⩾ 10 weeks after RTX. From our results we cannot recommend RBD for transplant ureteric stenosis at ⩾ 10 weeks after RTX, while previous reports show favourable results of antegrade BD in the initial 3 months after RTX.

Multiparametric Magnetic Resonance Imaging/Ultrasound Fusion Prostate Biopsy—Are 2 Biopsy Cores per Magnetic Resonance Imaging Lesion Required?

Purpose For multiparametric magnetic resonance imaging/ultrasound fusion prostate biopsy the number of biopsy cores obtained is arbitrarily established by urologists. Moreover, a general consensus is lacking on the number of biopsy cores to be obtained from a single magnetic resonance imaging lesion. Therefore, we evaluated the feasibility of obtaining only 1 biopsy core per magnetic resonance imaging lesion. Materials and Methods We retrospectively evaluated a total of 2,128 biopsy cores of 1,064 prostatic lesions (2 cores per lesion) in 418 patients in regard to prostate cancer detection (histology) and the Gleason score of the first biopsy core compared to the second biopsy core. Two analyses were performed, including patient level analysis based on prostate cancer detection per patient and lesion level analysis based exclusively on the histology of each lesion regardless of the overall histological outcome of the case. Results The overall prostate cancer detection rate was 45.7% (191 of 418 patients). The first biopsy core detected 170 of all 191 prostate cancers (89%). In 17 of these 170 prostate cancers (10%) the second biopsy core revealed Gleason score upgrading. Nine of the 21 prostate cancers (43%) missed by the first biopsy core had a Gleason score of 6. Altogether 537 of the 2,128 biopsy cores were positive, including 283 first (26.6%) and 254 second (24%) biopsy cores (p ≤0.001). The concordance between the first and second biopsy cores was 89% (&kgr; = 0.71). There was a discrepancy with Gleason score upgrading in 28 of 212 lesions (13.2%) with positive first and second biopsy cores. Conclusions Our study shows that obtaining more than 1 biopsy core per magnetic resonance imaging lesion only slightly improves the prostate cancer detection rate and Gleason grading.