mpMRI-targeted biopsy of the prostate in men ≥ 75 years. 7-year report from a high-volume referral center.

OBJECTIVE: Multiparametric magnetic resonance imaging (mpMRI) -Ultrasound- fusion guided biopsy of the prostate (FBx) is the new gold standard for the detection of prostate cancer. Hallmark studies showing superior detection rates of FBx over randomized biopsies routinely excluded patients≥75 years and information on outcome of FBx on this patient cohort is sparse. As a large referral center, we have performed FBx on a substantial number of patients this age. By evaluating outcome of FBx of patients over the age of 75 years we wanted to close the gap of knowledge on this patient cohort. MATERIALS AND METHODS: Between 2015 -2022, 1577 patients underwent FBx at our department and were considered for analysis. Clinical and histopathological parameters were recorded. Clinical data comprised age at FBx, serum level of Prostate-specific antigen (PSA), prostate volume, PSA-density, history of previous biopsies of the prostate, result of the digital rectal examination (DRE) and assessment of the indexlesion of mpMRI according to the Prostate Imaging and Reporting Data System (PI-RADS). Univariate analysis and multivariable logistic regression was used to identify age barrier of 75 years as a potential risk factor of detection of clinically significant prostate cancer by FBx. RESULTS: 379/1577 patients (24%) were≥75 years and 1198/1577 (76%) patients were < 75 years, respectively. Preoperative PSA was significantly higher in patients≥75 years compared to patients < 75 years (9.54 vs. 7.8, p < 0.001). Patients≥75 years presented significantly more often with mpMRI target lesions classified as PI-RADS 5 compared to patients < 75 years (45% vs. 29%, p < 0.001). Detection rate of clinically significant prostate cancer was significantly higher in patients≥75 years compared to patients < 75 years (63% vs. 43%, p < 0.001). Aggressive prostate cancer grade ISUP 5 was significantly more often detected in patients≥75 years compared to patients < 75 years (13% vs. 8%, p = 0.03). On multivariable logistic regression model adjusted for PSA and PI-RADS score, age barrier of 75 years was identified as a significant risk factor for the detection of clinically significant prostate cancer by FBx (OR: 1.77, 95% CI: 1.36 -2.31, p < 0.001). CONCLUSION: After evaluation of a large patient cohort, we show that age≥75 years represents a significant risk factor for the detection of clinically significant prostate cancer. Further studies on mid- and long term outcome are necessary to draw conclusions for clinical decision making in this patient cohort.

Added value of randomised biopsy to multiparametric magnetic resonance imaging-targeted biopsy of the prostate in a contemporary cohort.

OBJECTIVE: To assess the added value of concurrent systematic randomised ultrasonography-guided biopsy (SBx) to multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy and the additional rate of overdiagnosis of clinically insignificant prostate cancer (ciPCa) by SBx in a large contemporary, real-world cohort. PATIENTS AND METHODS: A total of 1552 patients with positive mpMRI and consecutive mpMRI-targeted biopsy and SBx were enrolled. Added value and the rate of overdiagnosis by SBx was evaluated. PRIMARY OUTCOME: added value of SBx, defined as detection rate of clinically significant PCa (csPCa; International Society of Urological Pathology [ISUP] Grade ≥2) by SBx, while mpMRI-targeted biopsy was negative or showed ciPCa (ISUP Grade 1). SECONDARY OUTCOME: rate of overdiagnosis by SBx, defined as detection of ciPCa in patients with negative mpMRI-targeted biopsy and PSA level of <10 ng/mL. RESULTS: Detection rate of csPCa by mpMRI-targeted biopsy and/or SBx was 753/1552 (49%). Added value of SBx was 145/944 (15%). Rate of overdiagnosis by SBx was 146/656 (22%). Added value of SBx did not change when comparing patients with previous prostate biopsy and biopsy naïve patients. In multivariable analysis, a Prostate Imaging-Reporting and Data System (PI-RADS) 4 index lesion (odds ratio [OR] 3.19, 95% confidence interval [CI] 1.66-6.78; P = 0.001), a PI-RADS 5 index lesion (OR 2.89, 95% CI 1.39-6.46; P = 0.006) and age (OR 1.05, 95% CI 1.03-1.08; P < 0.001) were independently associated with added value of SBx. CONCLUSIONS: In our real-world analysis, we saw a significant impact on added value and added rate of overdiagnosis by SBx. Subgroup analysis showed no significant decrease of added value in any evaluated risk group. Therefore, we do not endorse omitting concurrent SBx to mpMRI-guided biopsy of the prostate.

The Impact of Prostate Volume on the Prostate Imaging and Reporting Data System (PI-RADS) in a Real-World Setting.

Multiparametric magnetic resonance imaging (mpMRI) has emerged as a new cornerstone in the diagnostic pathway of prostate cancer. However, mpMRI is not devoid of factors influencing its detection rate of clinically significant prostate cancer (csPCa). Amongst others, prostate volume has been demonstrated to influence the detection rates of csPCa. Particularly, increasing volume has been linked to a reduced cancer detection rate. However, information about the linkage between PI-RADS, prostate volume and detection rate is relatively sparse. Therefore, the current study aims to assess the association between prostate volume, PI-RADS score and detection rate of csP-Ca, representing daily practice and contemporary mpMRI expertise. Thus, 1039 consecutive patients with 1151 PI-RADS targets, who underwent mpMRI-guided prostate biopsy at our tertiary referral center, were included. Prior mpMRI had been assessed by a plethora of 111 radiology offices, including academic centers and private practices. mpMRI was not secondarily reviewed in house before biopsy. mpMRI-targeted biopsy was performed by a small group of a total of ten urologists, who had performed at least 100 previous biopsies. Using ROC analysis, we defined cut-off values of prostate volume for each PI-RADS score, where the detection rate drops significantly. For PI-RADS 4 lesions, we found a volume > 61.5 ccm significantly reduced the cancer detection rate (OR 0.24; 95% CI 0.16-0.38; p < 0.001). For PI-RADS 5 lesions, we found a volume > 51.5 ccm to significantly reduce the cancer detection rate (OR 0.39; 95% CI 0.25-0.62; p < 0.001). For PI-RADS 3 lesions, none of the evaluated clinical parameters had a significant impact on the detection rate of csPCa. In conclusion, we show that enlarged prostate volume represents a major limitation in the daily practice of mpMRI-targeted biopsy. This study is the first to define exact cut-off values of prostate volume to significantly impair the validity of PI-RADS assessed in a real-world setting. Therefore, the results of mpMRI-targeted biopsy should be interpreted carefully, especially in patients with prostate volumes above our defined thresholds.

[Common errors, pitfalls, and management of complications of prostate biopsy : The most common diagnostic and procedural challenges of transrectal fusion prostate biopsy in the initial diagnosis of clinically significant prostate cancer]. / Häufige Fehler, "Pitfalls" und Komplikationsmanagement der Prostatabiopsie : Die häufigsten diagnostischen und prozeduralen Herausforderungen der transrektalen Fusionsbiopsie der Prostata bei Erstdiagnose eines klinisch signifikanten Prostatakarzinoms.

BACKGROUND: Transrectal (TR) prostate biopsy is the gold standard in diagnosis of prostate cancer (PC). It requires a precise and safe technique for sample acquisition. OBJECTIVE: Several approaches will be discussed to avoid overdiagnosis, false-negative results, and complications of the procedure. MATERIALS AND METHODS: We analyzed national and European guidelines, systematic reviews, meta-analyses, as well as prospective and retrospective studies to describe current trends in indication and performance of biopsies. RESULTS: Incorporation of risk calculators and magnetic resonance imaging (MRI) into daily routine reduces biopsy rates and results in a more precise diagnosis of clinically significant prostate cancer (csPC). Combination of random- and MRI-fusion guided biopsy-but also extending the radius of sampling by 10 mm beyond the MRI lesion and a transperineal (TP) sampling approach - lead to a higher tumor-detection rate. Bleeding is the most common complication after prostate biopsy and is usually self-limiting. Postbiopsy infection rates can be reduced through TP biopsy. CONCLUSION: TR MRI-fusion guided biopsy is a widely acknowledged tool in primary diagnostics of csPC. Higher detection rates and safety can be achieved through a TP sampling approach.

[Transrectal vs. transperineal fusion biopsy of the prostate : Time to switch to the perineal technique-comparison of methods and description of the transperineal procedure under local anesthesia]. / Transrektale vs. transperineale Fusionsbiopsie der Prostata : Zeit für einen Wechsel zur perinealen Technik ­ Vergleich der Methoden und Beschreibung des transperinealen operativen Vorgehens in Lokalanästhesie.

The clinical and histological diagnosis of prostate cancer is a crucial aspect of the routine work of a urologist. The high prevalence of multiresistant microorganisms leads to an increased incidence of sepsis after transrectal prostate biopsy. It requires a switch from the still gold-standard method to the transperineal fusion biopsy procedure after multiparametric prostate magnetic resonance imaging (MRI). This article provides an overview of the most important differences between the two methods and gives a detailed methodological description of transperineal fusion biopsy under local anesthesia.

Adverse Pathology after Radical Prostatectomy of Patients Eligible for Active Surveillance-A Summary 7 Years after Introducing mpMRI-Guided Biopsy in a Real-World Setting.

OBJECTIVE: Over the last decade, active surveillance (AS) of low-risk prostate cancer has been increasing. The mpMRI fusion-guided biopsy of the prostate (FBx) is considered to be the gold standard in preoperative risk stratification. However, the role of FBx remains unclear in terms of risk stratification of low-risk prostate cancer outside high-volume centers. The aim of this study was to evaluate adverse pathology after radical prostatectomy (RP) in a real-world setting, focusing on patients diagnosed with Gleason score (GS) 6 prostate cancer (PCa) and eligible for AS by FBx. SUBJECTS AND METHODS: Between March 2015 and March 2022, 1297 patients underwent FBx at the Department of Urology, Ludwig-Maximilians-University of Munich, Germany. MpMRI for FBx was performed by 111 different radiology centers. FBx was performed by 14 urologists from our department with different levels of experience. In total, 997/1297 (77%) patients were diagnosed with prostate cancer; 492/997 (49%) of these patients decided to undergo RP in our clinic and were retrospectively included. Univariate and multivariable logistic regression analyses were performed to evaluate clinical and histopathological parameters associated with adverse pathology comparing FBx and RP specimens. To compare FBx and systematic randomized biopsies performed in our clinic before introducing FBx (SBx, n = 2309), we performed a propensity score matching on a 1:1 ratio, adjusting for age, number of positive biopsy cores, and initial PSA (iPSA). RESULTS: A total of 492 patients undergoing FBx or SBx was matched. In total, 55% of patients diagnosed with GS 6 by FBx were upgraded to clinically significant PCa (defined as GS ≥ 7a) after RP, compared to 52% of patients diagnosed by SBx (p = 0.76). A time delay between FBx and RP was identified as the only correlate associated with upgrading. A total of 5.9% of all FBx patients and 6.1% of all SBx patients would have been eligible for AS (p > 0.99) but decided to undergo RP. The positive predictive value of AS eligibility (diagnosis of low-risk PCa after biopsy and after RP) was 17% for FBx and 6.7% for SBx (p = 0.39). CONCLUSIONS: In this study, we show, in a real-world setting, that introducing FBx did not lead to significant change in ratio of adverse pathology for low-risk PCa patients after RP compared to SBx.

Surgical Trends and Complications in Partial and Radical Nephrectomy: Results from the GRAND Study.

BACKGROUND: We aimed to evaluate the current trends in renal cancer surgery, as well as to compare the perioperative outcomes of partial versus radical nephrectomy. METHODS: We used the GeRmAn Nationwide inpatient Data (GRAND), provided by the Research Data Center of the Federal Bureau of Statistics (2005-2021). We report the largest study in the field, with 317,843 patients and multiple patient-level analyses. RESULTS: Overall, 123,924 (39%) patients underwent partial and 193,919 (61%) underwent radical nephrectomy in Germany from 2005 to 2021. Of them, 57,308 (18%) were operated on in low-, 142,702 (45%) in intermediate-, and 117,833 (37%) in high-volume centers. A total of 249,333 (78%) patients underwent open, 44,994 (14%) laparoscopic, and 23,516 (8%) robotic nephrectomy. The number of patients undergoing renal surgery remained relatively stable from 2005 to 2021. Over the study period, the utilization of partial nephrectomy increased threefold, while radical nephrectomy decreased by about 40%. After adjusting for major risk factors in the multivariate regression analysis, radical nephrectomy was associated with 3.2-fold higher odds (95% CI: 3.2 to 3.9, p < 0.001) of 30-day mortality, longer hospitalization by 1.9 days (95% CI: 1.9 to 2, p < 0.001), and higher inpatient costs by EUR 1778 (95% CI: 1694 to 1862, p < 0.001) compared to partial nephrectomy. Furthermore, radical nephrectomy had a higher risk of in-hospital transfusion (p < 0.001), sepsis (p < 0.001), acute respiratory failure (p < 0.001), acute kidney disease (p < 0.001), acute thromboembolism (p < 0.001), surgical wound infection (p < 0.001), ileus (p < 0.001), intensive care unit admission (p < 0.001), and pancreatitis (p < 0.001). CONCLUSIONS: More patients are offered partial nephrectomy in Germany. Patients undergoing radical nephrectomy present with a higher rate of concomitant risk factors and have increased perioperative morbidity and mortality, prolonged hospitalization, and increased in-hospital costs.

Strategies to successfully prevent COVID-19 outbreak in vulnerable uro-oncology patient population.

PURPOSE: As COVID-19 pandemic persists with variants, and despite effective vaccination campaigns, breakthrough infections surge. We implemented strategies to protect vulnerable patients of the uro-oncologic outpatient clinic. We adopted proactive non-symptomatic risk reduction measures, which include non-symptomatic testing requirements for both patients and health care professionals (HCP), intensified patient tracing and contact reduction by implementation of digital health options. Here, we present our best practice example to safely guide oncology professionals and patients with metastasized genitourinary cancers through the current and future pandemics. METHODS: Solely for this purpose, we created a registry of collected data (current telephone numbers, e-mail addresses, vaccination status). We collected a nasopharyngeal swab from every patient upon presentation for treatment. We implemented bi-weekly RNA-PCR assay tests for HCP with patient contact, and limited personal contact at our facility through digital patient consultations. RESULTS: We started implementing our COVID prevention model at the beginning of the second wave in September 2020 and included 128 patients with urologic malignancies requiring systemic treatment. After COVID vaccination became available in December 2020, all of our HCP were fully vaccinated within 6 weeks and 97% of our patients (125/128) within 9 months. We performed 1410 nasopharyngeal swabs during in-house visits, thereby detecting two COVID-19 infections among our patients, who both survived and successfully continued treatment. To further reduce personal contact, half of our consultations were fully operated digitally, with 76% (97/128) of our patients participating in our digital health offers. CONCLUSION: The willingness of patients and HCPs to participate in the study allowed us to implement strict standards to prepare for the ongoing and future pandemics in outpatient cancer units. Next to general preventive measures such as frequent hand disinfection, wearing facial masks, and keeping distance, an important measure to protect vulnerable uro-oncology patients is the capability to perform virus genome sequencing to trace transmission chains.

Telehealth in Uro-oncology Beyond the Pandemic: Toll or Lifesaver?

BACKGROUND: Telehealth services are rapidly embraced in uro-oncology due to the current coronavirus disease 2019 (COVID-19) pandemic. OBJECTIVE: To determine patients' perspective on adoption of telehealth as a response to the pandemic and its sustainability in the future. DESIGN, SETTING, AND PARTICIPANTS: Following a COVID-19 outbreak, 101 patients with advanced genitourinary cancers are currently managed "virtually" for therapy administration at our tertiary care unit. They were surveyed about the current situation, and current and long-term employment of telehealth. INTERVENTION: Rapid implementation of virtual patient management. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients' perception of anxiety of COVID-19 and cancer, perspective on telehealth measures as a reaction to the current COVID-19 pandemic, and long-term acceptance were used as outcomes. Wilcoxon matched-pair signed rank test, chi-square test, and Mann-Whitney U test were performed. RESULTS AND LIMITATIONS: Of 101 patients, 92 answered the questionnaire, with 71 (77.2%) responding virtually by e-mail or phone call. Anxiety of cancer (6/10, interquartile range [IQR] 3-8) superseded that of COVID-19 (four/10, IQR 2-5.25, p<0.001), and patients oppose temporary treatment interruption. Of the patients, 66.0% perceive their susceptibility to COVID-19 as equal to or lower than the general population and 52.2% believe that COVID-19 will not affect their therapy. In future, patients (62.6%) prefer to maintain in-person appointments as opposed to complete remote care, but accept remote care during the pandemic (eight/10, IQR 5-9). Beyond the crisis, maintaining telehealth has low preference rates (four/10, IQR 2-7), with high acceptance for external laboratory controls (60.9%) and online visit management (48.9%), but lower acceptance for remote treatment planning including staging discussions (44.6%) and for referral to secondary care oncologists (17.4%). CONCLUSIONS: Despite the pandemic, cancer remains the key concern and patients are not willing to compromise on their treatment. Rapid implementation of telehealth is tolerated well during the need of social distancing, with a clear "red line" concerning changes in existing patient-physician relationships. Balancing future implementation of telehealth while considering patients' demand for personal relationships will ensure human dignity in uro-oncology. PATIENT SUMMARY: We queried patients with genitourinary cancers treated in an almost virtual setting following a local coronavirus outbreak. Acceptance of telehealth during the current situation is high; however, long-term implementation of the adapted services is less favored. We deduce that patient-physician relationship is crucial for cancer patients and needs to be balanced against measures for social distancing to forge the future management.