Radiation Protection and Occupational Exposure on 68Ga-PSMA-11-Based Cerenkov Luminescence Imaging Procedures in Robot-Assisted Prostatectomy.

Cerenkov luminescence imaging (CLI) was successfully implemented in the intraoperative context as a form of radioguided cancer surgery, showing promise in the detection of surgical margins during robot-assisted radical prostatectomy. The present study was designed to provide a quantitative description of the occupational radiation exposure of surgery and histopathology personnel from CLI-guided robot-assisted radical prostatectomy after the injection of 68Ga-PSMA-11 in a single-injection PET/CT CLI protocol. Methods: Ten patients with preoperative 68Ga-PSMA-11 administration and intraoperative CLI were included. Patient dose rate was measured before PET/CT (n = 10) and after PET/CT (n = 5) at a 1-m distance for 4 patient regions (head [A], right side [B], left side [C], and feet [D]). Electronic personal dosimetry (EPD) was used for intraoperative occupational exposure (n = 10). Measurements included the first surgical assistant and scrub nurse at the operating table and the CLI imager/surgeon at the robotic console and encompassed the whole duration of surgery and CLI image acquisition. An estimation of the exposure of histopathology personnel was performed by measuring prostate specimens (n = 8) with a germanium detector. Results: The measured dose rate value before PET/CT was 5.3 ± 0.9 (average ± SD) µSv/h. This value corresponds to a patient-specific dose rate constant for positions B and C of 0.047 µSv/h⋅MBq. The average dose rate value after PET/CT was 1.04 ± 1.00 µSv/h. The patient-specific dose rate constant values corresponding to regions A to D were 0.011, 0.026, 0.024, and 0.003 µSv/h⋅MBq, respectively. EPD readings revealed average personal equivalent doses of 9.0 ± 7.1, 3.3 ± 3.9, and 0.7 ± 0.7 µSv for the first surgical assistant, scrub nurse, and CLI imager/surgeon, respectively. The median germanium detector-measured activity of the prostate specimen was 2.96 kBq (interquartile range, 2.23-7.65 kBq). Conclusion: Single-injection 68Ga-PSMA-11 PET/CT CLI procedures are associated with a reasonable occupational exposure level, if kept under 110 procedures per year. Excised prostate specimen radionuclide content was below the exemption level for 68Ga. Dose rate-based calculations provide a robust estimation for EPD measurements.

To defer or not to defer? A German longitudinal multicentric assessment of clinical practice in urology during the COVID-19 pandemic.

INTRODUCTION: After the outbreak of COVID-19 unprecedented changes in the healthcare systems worldwide were necessary resulting in a reduction of urological capacities with postponements of consultations and surgeries. MATERIAL AND METHODS: An email was sent to 66 urological hospitals with focus on robotic surgery (RS) including a link to a questionnaire (e.g. bed/staff capacity, surgical caseload, protection measures during RS) that covered three time points: a representative baseline week prior to COVID-19, the week of March 16th-22nd and April 20th-26th 2020. The results were evaluated using descriptive analyses. RESULTS: 27 out of 66 questionnaires were analyzed (response rate: 41%). We found a decrease of 11% in hospital beds and 25% in OR capacity with equal reductions for endourological, open and robotic procedures. Primary surgical treatment of urolithiasis and benign prostate syndrome (BPS) but also of testicular and penile cancer dropped by at least 50% while the decrease of surgeries for prostate, renal and urothelial cancer (TUR-B and cystectomies) ranged from 15 to 37%. The use of personal protection equipment (PPE), screening of staff and patients and protection during RS was unevenly distributed in the different centers-however, the number of COVID-19 patients and urologists did not reach double digits. CONCLUSION: The German urological landscape has changed since the outbreak of COVID-19 with a significant shift of high priority surgeries but also continuation of elective surgical treatments. While screening and staff protection is employed heterogeneously, the number of infected German urologists stays low.

External validation of novel magnetic resonance imaging-based models for prostate cancer prediction.

OBJECTIVES: To validate, in an external cohort, three novel risk models, including the recently updated European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculator, that combine multiparametric magnetic resonance imaging (mpMRI) and clinical variables to predict clinically significant prostate cancer (PCa). PATIENTS AND METHODS: We retrospectively analysed 307 men who underwent mpMRI prior to transperineal ultrasound fusion biopsy between October 2015 and July 2018 at two German centres. mpMRI was rated by Prostate Imaging Reporting and Data System (PI-RADS) v2.0 and clinically significant PCa was defined as International Society of Urological Pathology Gleason grade group ≥2. The prediction performance of the three models (MRI-ERSPC-3/4, and two risk models published by Radtke et al. and Distler et al., ModRad and ModDis) were compared using receiver-operating characteristic (ROC) curve analyses, with area under the ROC curve (AUC), calibration curve analyses and decision curves used to assess net benefit. RESULTS: The AUCs of the three novel models (MRI-ERSPC-3/4, ModRad and ModDis) were 0.82, 0.85 and 0.83, respectively. Calibration curve analyses showed the best intercept for MRI-ERSPC-3 and -4 of 0.35 and 0.76. Net benefit analyses indicated clear benefit of the MRI-ERSPC-3/4 risk models compared with the other two validated models. The MRI-ERSPC-3/4 risk models demonstrated a discrimination benefit for a risk threshold of up to 15% for clinically significant PCa as compared to the other risk models. CONCLUSION: In our external validation of three novel prostate cancer risk models, which incorporate mpMRI findings, a head-to-head comparison indicated that the MRI-ERSPC-3/4 risk model in particular could help to reduce unnecessary biopsies.

Comparison of the determination of the local tumor extent of primary endometrial cancer using clinical examination and 3 Tesla magnetic resonance imaging compared to histopathology.

PURPOSE: The aim of this study is to analyze the correct staging of primary endometrial cancer (EC) using clinical examination and 3 Tesla (T) magnetic resonance imaging (MRI) results compared to histopathology. METHODS: In this prospective, non-randomized, single-center study, 26 women with biopsy-proven EC were evaluated. All women underwent clinical examination including transvaginal ultrasound (CE/US) and 3T MRI (T2-weighted, diffusion-weighted and dynamic contrast-enhanced sequences) prior to surgery. Spearman's correlation coefficient was employed to analyze the correlation between both staging methods and histopathology and generalized estimation equation analysis to compare their staging results. Main outcome measures are determinations of local tumor extent for EC on CE/US and 3T MRI compared to histopathology (gold standard). RESULTS: Sixteen women had an early-stage pT1a tumor, 10 a locally advanced ≥ pT1b tumor. The early stage was correctly diagnosed at CE/US in 100%, by MRI in 81%. Spearman's correlation coefficient was r = 1.0 (p < 0.001) for correlation of CE/US and histopathology, r = 0.93 (p < 0.001) for correlation of MRI and pathology. A locally advanced tumor stage was exactly diagnosed by MRI in 70% and at CE/US in 50%. CONCLUSIONS: CE/US is sufficient for staging T1a endometrial cancer, while MRI provides higher sensitivity in detecting locally advanced tumors. Based on our results, combining CE/US and 3T MRI in patients with at least suspected deep myometrial invasion offers a more reliable workflow for individual treatment planning.

Multiparametric MRI fusion-guided biopsy for the diagnosis of prostate cancer.

PURPOSE OF REVIEW: To discuss the timing, benefits, limitations and current controversies of multiparametric magnet resonance imaging (mpMRI) combined with fusion-guided biopsy and consider how additional incorporation of multivariable risk stratification might further improve prostate cancer diagnosis. RECENT FINDINGS: MpMRI has been proven advantageous over standard practice for biopsy-naïve men and men with previous biopsy in large prospective studies providing level 1b evidence. Upfront multivariable risk stratification followed by or combined with mpMRI further improves diagnostic accuracy. Regarding active surveillance, mpMRI in combination with fusion biopsy can support initial candidate selection and may help to monitor disease progression. mpMRI and fusion biopsy, however, do not spare failure and conflicting data exists to what extend (systematic) biopsies can be omitted. SUMMARY: Integration of mpMRI into the diagnostic pathway for prostate cancer is beneficial; yet more prospective and randomized data is needed to establish reliable procedure standards after mpMRI acquisition.

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study.

INTRODUCTION: The aim of the present study was to explore the clinical feasibility and reproducibility of a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol for imaging prostate cancer (PC) patients. METHODS: Eight patients with high-risk biopsy-proven PC underwent a whole-body PET/MRI (3 h p.i.) including a multi-parametric prostate MRI after 18F-PSMA-1007-PET/CT (1 h p.i.) which served as reference. Seven patients presented with non-treated PC, whereas one patient presented with biochemical recurrence. SUVmean-quantification was performed using a 3D-isocontour volume-of-interest. Imaging data was consulted for TNM-staging and compared with histopathology. PC was confirmed in 4/7 patients additionally by histopathology after surgery. PET-artifacts, co-registration of pelvic PET/MRI and MRI-data were assessed (PI-RADS 2.0). RESULTS: The examinations were well accepted by patients and comprised 1 h. SUVmean-values between PET/CT (1 h p.i.) and PET/MRI (3 h p.i.) were significantly correlated (p < 0.0001, respectively) and similar to literature of 18F-PSMA-1007-PET/CT 1 h vs 3 h p.i. The dominant intraprostatic lesion could be detected in all seven patients in both PET and MRI. T2c, T3a, T3b and T4 features were detected complimentarily by PET and MRI in five patients. PET/MRI demonstrated moderate photopenic PET-artifacts surrounding liver and kidneys representing high-contrast areas, no PET-artifacts were observed for PET/CT. Simultaneous PET-readout during prostate MRI achieved optimal co-registration results. CONCLUSIONS: The presented 18F-PSMA-1007-PET/MRI protocol combines efficient whole-body assessment with high-resolution co-registered PET/MRI of the prostatic fossa for comprehensive oncological staging of patients with PC.

Multiparametric-MRI-Guided Biopsy in the Era of Precision Medicine. / Biopsia dirigida por resonancia magnética multiparamétrica en la era de la medicina personalizada.

OBJECTIVE: Technical improvements in prostate magnetic resonance imaging (MRI) have resulted in the use of MRI to target prostate biopsy. This allowed urologists to progress from blind biopsies to target biopsies with a better performance in prostate cancer (PC) diagnosis. We herein review the current status of Magnetic Resonance Imaging Guided Biopsy (MRGB) for the detection of PC. METHODS: A systematic review of the literature was conducted using PubMed, Embase and Cochrane using the search criteria: "PC and MRI/US fusion" or "PC and guided biopsy" or "PC and multiparametric MRI" or "PC and MRI guided prostate biopsy". Four reviewers coindependently assessed 8228 records and 38 records directly comparing MRGB with transrectal ultrasoundguided biopsy (TRUS) were chosen. However, a risk bias assessment was not performed. RESULTS: In naive patients, MRGB detected similar PC (51% vs 47.5%) than TRUS, more significant PC (SPC [41% vs 33%]) and less not significant PC (NSPC [7.7% vs 14.5%]) with less number of biopsies. In patients with previous negative prostate biopsy MRGB detected more PC (46.3% vs 26.6%), more SPC (32 % vs 16%) and less NSPC (9.5% vs 14.5%) than TRUS, with less number of biopsies. Besides, in previous biopsy patients group MRGB is better at detecting anterior PC than TRUS. CONCLUSION: MRGB increased PC detection in patients with previous biopsies and also increased SPC detection at the expense of decreasing NSPC detection in both groups of patients with fewer biopsies when compared with TRUS. These results demonstrate the value of MRGB in PC diagnosis.

Biopsia dirigida por resonancia magnética multiparamétrica en la era de la medicina personalizada / Multiparametric-MRI-Guided Biopsy in the Era of Precision Medicine

Objetivo: La mejora en la resonancia magnética (RM) prostática permitió pasar de la biopsia prostática (BP) a ciegas, a dirigir la biopsia a un área prostática sospechosa, con un mejor rendimiento diagnóstico en la detección del cáncer de próstata (CP). El objetivo de este artículo fue evaluar el estado actual de la BP dirigida por RM (BDRM). Métodos: Se realizó una revisión sistemática de la literatura mediante PubMed, Embase y Cochrane con los criterios de búsqueda: CP y fusión RM/US (ultrasonido) o CP y biopsia dirigida (BD) o CP y RM multiparamétrica o CP y BDRM. Cuatro revisores evaluaron 8228 registros y escogieron 38 artículos que comparaban la BDRM con la biopsia sistemática (BS). Sin embargo, no se realizó una valoración del riesgo de sesgo. Resultados: En los pacientes naïve la BDRM detectó similar CP (51% vs 47,5%), más CP significativo (CPS [41% vs 33%]) y menos CP no significativo (CPNS [7,7% vs 14,5%]) que la BS; con un menor número de biopsias. En los pacientes con antecedentes de BS previamente negativa, la BDRM detectó más CP (46,3% vs 26,6%), más CPS (32% vs 16%) y menos CPNS (9,5% vs 14,5%) que la BS; con un menor número de biopsias. Además la BDRM detectó más CP en la región prostática anterior que la BS en este último grupo de pacientes. Conclusión: La BDRM aumentó la detección de CP en los pacientes con una biopsia previa. También aumentó la detección de CPS a expensas de la disminución de la detección CPNS en ambos grupos de pacientes, con una menor cantidad de biopsias, al compararla con la BS. Estos resultados demuestran el valor de BDRM en el diagnóstico de CP (AU)

Objective: Technical improvements in prostate magnetic resonance imaging (MRI) have resulted in the use of MRI to target prostate biopsy. This allowed urologists to progress from blind biopsies to target biopsies with a better performance in prostate cancer (PC) diagnosis. We herein review the current status of Magnetic Resonance Imaging Guided Biopsy (MRGB) for the detection of PC. Methods: A systematic review of the literature was conducted using PubMed, Embase and Cochrane using the search criteria: "PC and MRI/US fusion" or "PC and guided biopsy" or "PC and multiparametric MRI" or "PC and MRI guided prostate biopsy". Four reviewers independently assessed 8228 records and 38 records directly comparing MRGB with transrectal ultrasound-guided biopsy (TRUS) were chosen. However, a risk bias assessment was not performed. Results: In naive patients, MRGB detected similar PC (51% vs 47.5%) than TRUS, more significant PC (SPC [41% vs 33%]) and less not significant PC (NSPC [7.7% vs 14.5%]) with less number of biopsies. In patients with previous negative prostate biopsy MRGB detected more PC (46.3% vs 26.6%), more SPC (32 % vs 16%) and less NSPC (9.5% vs 14.5%) than TRUS, with less number of biopsies. Besides, in previous biopsy patients group MRGB is better at detecting anterior PC than TRUS. Conclusion: MRGB increased PC detection in patients with previous biopsies and also increased SPC detection at the expense of decreasing NSPC detection in both groups of patients with fewer biopsies when compared with TRUS. These results demonstrate the value of MRGB in PC diagnosis (AU)

Intraindividual Comparison of 18F-PSMA-1007 PET/CT, Multiparametric MRI, and Radical Prostatectomy Specimens in Patients with Primary Prostate Cancer: A Retrospective, Proof-of-Concept Study.

68Ga-prostate-specific membrane antigen (PSMA)-11 PET/CT represents an advanced method for the staging of primary prostate cancer (PCa) and diagnosis of recurrent or metastatic PCa. However, because of the narrow availability of 68Ga the development of alternative tracers is of high interest. The objective of this study was to examine the value of the new PET tracer 18F-PSMA-1007 for the staging of local disease by comparing it with multiparametric MRI (mpMRI) and radical prostatectomy (RP) histopathology. Methods: In 2016, 18F-PSMA-1007 PET/CT was performed in 10 men with biopsy-confirmed high-risk PCa. Nine patients underwent mpMRI in the process of primary diagnosis. Consecutively, RP was performed in all 10 men. Agreement analysis was performed retrospectively. PSMA staining was added for representative sections in RP specimen slices. Localization and agreement analysis of 18F-PSMA-1007 PET/CT, mpMRI, and RP specimens was performed by dividing the prostate into 38 sections as described in the prostate imaging reporting and data system (PI-RADS) (version 2). Sensitivity, specificity, positive predictive values, negative predictive values (NPVs), and accuracy were calculated for total and near-total agreement. Results:18F-PSMA-1007 PET/CT had an NPV of 68% and an accuracy of 75%, and mpMRI had an NPV of 88% and an accuracy of 73% for total agreement. Near-total agreement analysis resulted in an NPV of 91% and an accuracy of 93% for 18F-PSMA-1007 PET/CT and 91% and 87% for mpMRI, respectively. Retrospective combination of mpMRI and PET/CT had an accuracy of 81% for total and 93% for near-total agreement. Conclusion: Comparison with RP histopathology demonstrates that 18F-PSMA-1007 PET/CT is promising for accurate local staging of PCa.

The Value of PSA Density in Combination with PI-RADS™ for the Accuracy of Prostate Cancer Prediction.

PURPOSE: Multiparametric magnetic resonance imaging has an emerging role in prostate cancer diagnostics. In addition, clinical information is a reliable predictor of significant prostate cancer. We analyzed whether the negative predictive value of multiparametric magnetic resonance imaging to rule out significant prostate cancer could be improved using clinical factors, especially prostate specific antigen density. MATERIALS AND METHODS: A total of 1,040 consecutive men with suspicion of prostate cancer underwent multiparametric magnetic resonance imaging first, followed by transperineal systematic and magnetic resonance imaging-transrectal ultrasound fusion guided biopsy. Logistic regression analyses were performed to test different clinical factors as predictors of significant prostate cancer and build nomograms. To simplify these nomograms for clinical use patients were stratified into 3 prostate specific antigen density groups, including group 1-less than 0.07, group 2-0.07 to 0.15 and group 3-greater than 0.15 ng/ml/ml. After stratification we calculated the negative predictive value of a PI-RADS (Prostate Imaging Reporting and Data System) Likert score of less than 3. Significant prostate cancer was defined as a Gleason score of 3 + 4 or greater. High grade prostate cancer was defined as a Gleason score of 4 + 3 or greater. RESULTS: Overall 451 men were diagnosed with significant prostate cancer, including 187 with a Gleason score of 4 + 3 or greater. On ROC curve analyses the predictive power of the developed nomogram for significant prostate cancer showed a higher AUC than that of PI-RADS alone (0.79 vs 0.75, p <0.001). The negative predictive value of harboring significant prostate cancer increased in men with unsuspicious magnetic resonance imaging from 79% up to 89% when prostate specific antigen density was 0.15 ng/ml/ml or less. In the repeat biopsy setting the negative predictive value of significant prostate cancer increased from 83% to 93%. The negative predictive value to harbor high grade prostate cancer increased from 92% up to 98% in the entire cohort. CONCLUSIONS: Using prostate specific antigen density combined with multiparametric magnetic resonance imaging improved the negative predictive value of PI-RADS scoring. By increasing the probability of ruling out significant prostate cancer approximately 20% of unnecessary biopsies could be avoided safely.

Ureterocystoneostomy in complex oncological cases with an "Uebelhoer" modified Boari bladder flap.

PURPOSE: The study aims to describe the technique and analyze the outcome of an arcuated bladder incision with building of a triangular flap, first described by Uebelhoer (UBBF), as a modification of the classical rectangular Boari bladder flap (BBF), that is often viable, but can present difficulties, such as reduced flap vascularization and mobility in pretreated patients. METHODS: Twelve consecutive patients with distal or mid ureteral leakage or stenosis, that underwent UBBF, were retrospectively analyzed. We assessed postoperative morbidity using Clavien-Dindo classification. Short- and long-term functional outcomes were assessed using glomerular filtration rate (GFR), ultrasound, and renal scintigraphy. RESULTS: Patients underwent UBBF during initial oncological surgery in five cases and due to ureteral defects following oncological surgery or radiotherapy in seven cases. Median patient age was 57 (interquartile range (IQR) 46-72), defect length was 7.5 cm (IQR 5-8 cm), and median follow-up period was 41 (IQR 36-48) months. In short-term follow-up, 11/13 postoperative morbidities were Clavien-Dindo level I-II complications, mostly infections. Two level IIIa complications occurred. One anastomotic leakage was treated sufficiently with temporarily ureteral stenting and one voiding disorder needed intervention. In the long-term follow-up, 84% of patients had improved or constant GFR. In the one-year renal scintigraphy, no urodynamically relevant voiding disorder occurred. CONCLUSIONS: The UBBF is a reliable procedure to reconstruct ureteral trauma even in complex oncological, pretreated patients suffering from distal or mid ureteral defects. It can be performed easily by a modified arcuate incision and provides good long-term functional outcomes.

Local recurrence of prostate cancer after radical prostatectomy is at risk to be missed in 68Ga-PSMA-11-PET of PET/CT and PET/MRI: comparison with mpMRI integrated in simultaneous PET/MRI.

PURPOSE: The positron emission tomography (PET) tracer 68Ga-PSMA-11, targeting the prostate-specific membrane antigen (PSMA), is rapidly excreted into the urinary tract. This leads to significant radioactivity in the bladder, which may limit the PET-detection of local recurrence (LR) of prostate cancer (PC) after radical prostatectomy (RP), developing in close proximity to the bladder. Here, we analyze if there is additional value of multi-parametric magnetic resonance imaging (mpMRI) compared to the 68Ga-PSMA-11-PET-component of PET/CT or PET/MRI to detect LR. METHODS: One hundred and nineteen patients with biochemical recurrence after prior RP underwent both hybrid 68Ga-PSMA-11-PET/CTlow-dose (1 h p.i.) and -PET/MRI (2-3 h p.i.) including a mpMRI protocol of the prostatic bed. The comparison of both methods was restricted to the abdomen with focus on LR (McNemar). Bladder-LR distance and recurrence size were measured in axial T2w-TSE. A logistic regression was performed to determine the influence of these variables on detectability in 68Ga-PSMA-11-PET. Standardized-uptake-value (SUVmean) quantification of LR was performed. RESULTS: There were 93/119 patients that had at least one pathologic finding. In addition, 18/119 Patients (15.1%) were diagnosed with a LR in mpMRI of PET/MRI but only nine were PET-positive in PET/CT and PET/MRI. This mismatch was statistically significant (p = 0.004). Detection of LR using the PET-component was significantly influenced by proximity to the bladder (p = 0.028). The PET-pattern of LR-uptake was classified into three types (1): separated from bladder; (2): fuses with bladder, and (3): obliterated by bladder). The size of LRs did not affect PET-detectability (p = 0.84), mean size was 1.7 ± 0.69 cm long axis, 1.2 ± 0.46 cm short-axis. SUVmean in nine men was 8.7 ± 3.7 (PET/CT) and 7.0 ± 4.2 (PET/MRI) but could not be quantified in the remaining nine cases (obliterated by bladder). CONCLUSION: The present study demonstrates additional value of hybrid 68Ga-PSMA-11-PET/MRI by gaining complementary diagnostic information compared to the 68Ga-PSMA-11-PET/CTlow-dose for patients with LR of PC.

Multicentre evaluation of targeted and systematic biopsies using magnetic resonance and ultrasound image-fusion guided transperineal prostate biopsy in patients with a previous negative biopsy.

OBJECTIVES: To evaluate the detection rates of targeted and systematic biopsies in magnetic resonance imaging (MRI) and ultrasound (US) image-fusion transperineal prostate biopsy for patients with previous benign transrectal biopsies in two high-volume centres. PATIENTS AND METHODS: A two centre prospective outcome study of 487 patients with previous benign biopsies that underwent transperineal MRI/US fusion-guided targeted and systematic saturation biopsy from 2012 to 2015. Multiparametric MRI (mpMRI) was reported according to Prostate Imaging Reporting and Data System (PI-RADS) Version 1. Detection of Gleason score 7-10 prostate cancer on biopsy was the primary outcome. Positive (PPV) and negative (NPV) predictive values including 95% confidence intervals (95% CIs) were calculated. Detection rates of targeted and systematic biopsies were compared using McNemar's test. RESULTS: The median (interquartile range) PSA level was 9.0 (6.7-13.4) ng/mL. PI-RADS 3-5 mpMRI lesions were reported in 343 (70%) patients and Gleason score 7-10 prostate cancer was detected in 149 (31%). The PPV (95% CI) for detecting Gleason score 7-10 prostate cancer was 0.20 (±0.07) for PI-RADS 3, 0.32 (±0.09) for PI-RADS 4, and 0.70 (±0.08) for PI-RADS 5. The NPV (95% CI) of PI-RADS 1-2 was 0.92 (±0.04) for Gleason score 7-10 and 0.99 (±0.02) for Gleason score ≥4 + 3 cancer. Systematic biopsies alone found 125/138 (91%) Gleason score 7-10 cancers. In patients with suspicious lesions (PI-RADS 4-5) on mpMRI, systematic biopsies would not have detected 12/113 significant prostate cancers (11%), while targeted biopsies alone would have failed to diagnose 10/113 (9%). In equivocal lesions (PI-RADS 3), targeted biopsy alone would not have diagnosed 14/25 (56%) of Gleason score 7-10 cancers, whereas systematic biopsies alone would have missed 1/25 (4%). Combination with PSA density improved the area under the curve of PI-RADS from 0.822 to 0.846. CONCLUSION: In patients with high probability mpMRI lesions, the highest detection rates of Gleason score 7-10 cancer still required combined targeted and systematic MRI/US image-fusion; however, systematic biopsy alone may be sufficient in patients with equivocal lesions. Repeated prostate biopsies may not be needed at all for patients with a low PSA density and a negative mpMRI read by experienced radiologists.

Multiparametric Magnetic Resonance Imaging (MRI) and MRI-Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen.

BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) and MRI fusion targeted biopsy (FTB) detect significant prostate cancer (sPCa) more accurately than conventional biopsies alone. OBJECTIVE: To evaluate the detection accuracy of mpMRI and FTB on radical prostatectomy (RP) specimen. DESIGN, SETTING AND PARTICIPANTS: From a cohort of 755 men who underwent transperineal MRI and transrectal ultrasound fusion biopsy under general anesthesia between 2012 and 2014, we retrospectively analyzed 120 consecutive patients who had subsequent RP. All received saturation biopsy (SB) in addition to FTB of lesions with Prostate Imaging Reporting and Data System (PI-RADS) score ≥2. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The index lesion was defined as the lesion with extraprostatic extension, the highest Gleason score (GS), or the largest tumor volume (TV) if GS were the same, in order of priority. GS 3+3 and TV ≥1.3ml or GS ≥3+4 and TV ≥0.55ml were considered sPCa. We assessed the detection accuracy by mpMRI and different biopsy approaches and analyzed lesion agreement between mpMRI and RP specimen. RESULTS AND LIMITATIONS: Overall, 120 index and 71 nonindex lesions were detected. Overall, 107 (89%) index and 51 (72%) nonindex lesions harbored sPCa. MpMRI detected 110 of 120 (92%) index lesions, FTB (two cores per lesion) alone diagnosed 96 of 120 (80%) index lesions, and SB alone diagnosed 110 of 120 (92%) index lesions. Combined SB and FTB detected 115 of 120 (96%) index foci. FTB performed significantly less accurately compared with mpMRI (p=0.02) and the combination for index lesion detection (p=0.002). Combined FTB and SB detected 97% of all sPCa lesions and was superior to mpMRI (85%), FTB (79%), and SB (88%) alone (p<0.001 each). Spearman's rank correlation coefficient for index lesion agreement between mpMRI and RP was 0.87 (p<0.001). Limitations included the retrospective design, multiple operators, and nonblinding of radiologists. CONCLUSIONS: MpMRI identified 92% of index lesions compared with RP histopathology. The combination of FTB and SB was superior to both approaches alone, reliably detecting 97% of sPCa lesions. PATIENT SUMMARY: Multiparametric magnetic resonance imaging detects the index lesion accurately in 9 of 10 patients; however, the combined biopsy approach, while missing less significant cancer, comes at the cost of detecting more insignificant cancer.

Comparison of hybrid (68)Ga-PSMA PET/MRI and (68)Ga-PSMA PET/CT in the evaluation of lymph node and bone metastases of prostate cancer.

PURPOSE: To evaluate the reproducibility of the combination of hybrid PET/MRI and the (68)Ga-PSMA-11 tracer in depicting lymph node (LN) and bone metastases of prostate cancer (PC) in comparison with that of PET/CT. MATERIALS AND METHODS: A retrospective analysis of 26 patients who were subjected to (68)Ga-PSMA PET/CTlow-dose (1 h after injection) followed by PET/MRI (3 h after injection) was performed. MRI sequences included T1-w native, T1-w contrast-enhanced, T2-w fat-saturated and diffusion-weighted sequences (DWIb800). Discordant PET-positive and morphological findings were evaluated. Standardized uptake values (SUV) of PET-positive LNs and bone lesions were quantified and their morphological size and conspicuity determined. RESULTS: Comparing the PET components, the proportion of discordant PSMA-positive suspicious findings was very low (98.5 % of 64 LNs concordant, 100 % of 28 bone lesions concordant). Two PET-positive bone metastases could not be confirmed morphologically using CTlow-dose, but could be confirmed using MRI. In 12 of 20 patients, 47 PET-positive LNs (71.9 %) were smaller than 1 cm in short axis diameter. There were significant linear correlations between PET/MRI SUVs and PET/CT SUVs in the 64 LN metastases (p < 0.0001) and in the 28 osseous metastases (p < 0.0001) for SUVmean and SUVmax, respectively. The LN SUVs were significantly higher on PET/MRI than on PET/CT (p SUVmax < 0.0001; p SUVmean < 0.0001) but there was no significant difference between the bone lesion SUVs (p SUVmax = 0.495; p SUVmean = 0.381). Visibility of LNs was significantly higher on MRI using the T1-w contrast-enhanced fat-saturated sequence (p = 0.013), the T2-w fat-saturated sequence (p < 0.0001) and the DWI sequence (p < 0.0001) compared with CTlow-dose. For bone lesions, only the overall conspicuity was higher on MRI compared with CTlow-dose (p < 0.006). CONCLUSION: Nodal and osseous metastases of PC are accurately and reliably depicted by hybrid PET/MRI using (68)Ga-PSMA-11 with very low discordance compared with PET/CT including PET-positive LNs of normal size. The correlation between PET/MRI SUVs and PET/CT SUVs was linear in LN and bone metastases but was significantly lower in control (non-metastatic) tissue.

Comparative analysis of transperineal template saturation prostate biopsy versus magnetic resonance imaging targeted biopsy with magnetic resonance imaging-ultrasound fusion guidance.

PURPOSE: Multiparametric magnetic resonance imaging and magnetic resonance imaging targeted biopsy may improve the detection of clinically significant prostate cancer. However, standardized prospective evaluation is limited. MATERIALS AND METHODS: A total of 294 consecutive men with suspicion of prostate cancer (186 primary, 108 repeat biopsies) enrolled in 2013 underwent 3T multiparametric magnetic resonance imaging (T2-weighted, diffusion weighted, dynamic contrast enhanced) without endorectal coil and systematic transperineal cores (median 24) independently of magnetic resonance imaging suspicion and magnetic resonance imaging targeted cores with software registration (median 4). The highest Gleason score from each biopsy method was compared. McNemar's tests were used to evaluate detection rates. Predictors of Gleason score 7 or greater disease were assessed using logistic regression. RESULTS: Overall 150 cancers and 86 Gleason score 7 or greater cancers were diagnosed. Systematic, transperineal biopsy missed 18 Gleason score 7 or greater tumors (20.9%) while targeted biopsy did not detect 11 (12.8%). Targeted biopsy of PI-RADS 2-5 alone overlooked 43.8% of Gleason score 6 tumors. McNemar's tests for detection of Gleason score 7 or greater cancers in both modalities were not statistically significant but showed a trend of superiority for targeted primary biopsies (p=0.08). Sampling efficiency was in favor of magnetic resonance imaging targeted prostate biopsy with 46.0% of targeted biopsy vs 7.5% of systematic, transperineal biopsy cores detecting Gleason score 7 or greater cancers. To diagnose 1 Gleason score 7 or greater cancer, 3.4 targeted and 7.4 systematic biopsies were needed. Limiting biopsy to men with PI-RADS 3-5 would have missed 17 Gleason score 7 or greater tumors (19.8%), demonstrating limited magnetic resonance imaging sensitivity. PI-RADS scores, digital rectal examination findings and prostate specific antigen greater than 20 ng/ml were predictors of Gleason score 7 or greater disease. CONCLUSIONS: Compared to systematic, transperineal biopsy as a reference test, magnetic resonance imaging targeted biopsy alone detected as many Gleason score 7 or greater tumors while simultaneously mitigating the detection of lower grade disease. The gold standard for cancer detection in primary biopsy is a combination of systematic and targeted cores.