Comparison of ciprofloxacin versus fosfomycin versus fosfomycin plus trimethoprim/sulfamethoxazole for preventing infections after transrectal prostate biopsy.

BACKGROUND: To evaluate antibiotic prophylaxis in transrectal prostate biopsies due to the recommendation of the European Medicines Agency (EMA): We describe our single center experience switching from ciprofloxacin to fosfomycin trometamol (FMT) alone and to an augmented prophylaxis combining fosfomycin and trimethoprim/sulfamethoxazole (TMP/SMX). METHODS: Between 01/2019 and 12/2020 we compared three different regimes. The primary endpoint was the clinical diagnosis of an infection within 4 weeks after biopsy. We enrolled 822 men, 398 (48%) of whom received ciprofloxacin (group-C), 136 (16.5%) received FMT (group-F) and 288 (35%) received the combination of TMP/SMX and FMT (group-BF). RESULTS: Baseline characteristics were similar between groups. In total 37/398 (5%) postinterventional infections were detected, of which 13/398 (3%) vs 18/136 (13.2%) vs 6/288 (2.1%) were detected in group-C, group-F and group-BF respectively. The relative risk of infectious complication was 1.3 (CI 0.7-2.6) for group-C vs. group-BF and 2.8 (CI 1.4-5.7) for group-F vs. group-BF respectively. CONCLUSION: The replacement of ciprofloxacin by fosfomycin alone resulted in a significant increase of postinterventional infections, while the combination of FMT and TMP/SMX had a comparable infection rate to FQ without apparent adverse events. Therefore, this combined regimen of FMT and TMP/SMX is recommended.

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis.

BACKGROUND: Remote patient monitoring (RPM) is an option for continuously managing the care of patients in the comfort of their homes or locations outside hospitals and clinics. Patient engagement with RPM programs is essential for achieving successful outcomes and high quality of care. When relying on technology to facilitate monitoring and shifting disease management to the home environment, it is important to understand the patients' experiences to enable quality improvement. OBJECTIVE: This study aimed to describe patients' experiences and overall satisfaction with an RPM program for acute and chronic conditions in a multisite, multiregional health care system. METHODS: Between January 1, 2021, and August 31, 2022, a patient experience survey was delivered via email to all patients enrolled in the RPM program. The survey encompassed 19 questions across 4 categories regarding comfort, equipment, communication, and overall experience, as well as 2 open-ended questions. Descriptive analysis of the survey response data was performed using frequency distribution and percentages. RESULTS: Surveys were sent to 8535 patients. The survey response rate was 37.16% (3172/8535) and the completion rate was 95.23% (3172/3331). Survey results indicated that 88.97% (2783/3128) of participants agreed or strongly agreed that the program helped them feel comfortable managing their health from home. Furthermore, 93.58% (2873/3070) were satisfied with the RPM program and ready to graduate when meeting the program goals. In addition, patient confidence in this model of care was confirmed by 92.76% (2846/3068) of the participants who would recommend RPM to people with similar conditions. There were no differences in ease of technology use according to age. Those with high school or less education were more likely to agree that the equipment and educational materials helped them feel more informed about their care plans than those with higher education levels. CONCLUSIONS: This multisite, multiregional RPM program has become a reliable health care delivery model for the management of acute and chronic conditions outside hospitals and clinics. Program participants reported an excellent overall experience and a high level of satisfaction in managing their health from the comfort of their home environment.

68Ga-Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography-Based Primary Staging and Histological Correlation after Extended Pelvic Lymph Node Dissection in Intermediate-Risk Prostate Cancer.

OBJECTIVE: The objective of this study is to evaluate prostate-specific membrane antigen positron emission tomography-computed tomography (PSMA PET/CT)-based primary staging in exclusively D'Amico intermediate-risk prostate cancer (PCa) patients. PATIENTS AND METHODS: We relied on the Braunschweig institutional database and retrospectively identified D'Amico intermediate-risk PCa patients who were administered to 68Ga-PSMA PET/CT-based primary staging prior to consecutive radical prostatectomy and extended lymph node dissection. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the detection of lymph node metastases were analyzed per-patient (n = 39), per-pelvic side (n = 78), and per-anatomic-region (external iliac artery and vein left/right vs. obturator fossa left/right vs. internal iliac artery left/right) (n = 203), respectively. RESULTS: Sensitivity, specificity, PPV, and NPV per-patient were 20.0, 94.1, 33.3, and 88.9%, respectively. Sensitivity, specificity, PPV, and NPV per-pelvic-side were 16.7, 97.2, 33.3, and 93.3%, respectively. Sensitivity, specificity, PPV, and NPV per-anatomic-region were 16.7, 99.0, 33.3, and 97.5%, respectively. CONCLUSIONS: We recorded high rates of specificity and NPV for 68Ga-PSMA PET/CT-based primary staging in D'Amico intermediate-risk PCa patients. Conversely, the sensitivity and PPV were lower than anticipated. Larger and favorably prospective trials are needed to verify our results and to unravel possible bias from such smaller studies.

Indication for Active Surveillance in the Era of MRI-Targeted Prostate Biopsies.

INTRODUCTION: Active surveillance (AS) strategies were established to avoid overtreatment of low-risk prostate cancer (PCa) patients. Low tumor volume represents one indication criteria; however, applying this criterion after MRI-targeted prostate biopsies may lead to overestimation of tumor volume; wherefore, patients suitable for AS would be exposed to the risk of overtreatment. METHODS: This retrospective analysis included 318 patients in which PCa was detected by MRI-TRUS fusion prostate biopsy. Classic and extended indication for AS included Gleason 6 and Gleason 3 + 4 cancer, respectively. We assessed the effect of targeted biopsies and temporary rating strategies on eligibility for AS and developed new "composite" algorithms to more accurately assess eligibility for AS. RESULTS: Forty-four (13.8%) and 60 (18.9%) of the 318 patients qualified for AS according to "classic" and "extended" criteria, respectively. Application of the "composite 1" definition led to AS eligibility of 52 of 248 patients (20.97%) in the classic and of 77 of 248 patients (31.05%) in the "extended" group. CONCLUSIONS: We could demonstrate that classic algorithms led to ineligibility of patients for AS. We propose a new rating algorithm to improve tumor assessment for a more accurate indication for AS.

Efficacy, safety, and perioperative outcomes of holmium laser enucleation of the prostate-a comparison of patients with lower urinary tract symptoms and urinary retention.

Holmium laser enucleation of the prostate (HoLEP) is a valid treatment option to relieve bladder outlet obstruction in patients with large prostate volumes (PV). Its efficacy, tolerability, and safety are comparable to the ones of other laser treatments of the prostate and resection techniques. However, safety and efficacy of HoLEP have not been compared between patients with and without preoperative urinary retention. We included 350 patients (mean age 71.2 years) who had undergone HoLEP due to lower urinary tract symptoms (LUTS) or urinary retention caused by prostatic hyperplasia. We evaluated the differences in peri- and postoperative outcomes and complications between patients with and patients without preoperative urinary retention. The mean PV was 115 cm3. PV was > 100 cm3 in 61.9% and < 100 cm3 in 38.1% of the patients. Perioperative complications occurred in 23 patients (6.6%), 15 of which (4.3%) required operative revision. We found no significant differences in terms of complication rates between patients with PV > 100 cm3 and patients with PV < 100 cm3. Mean catheterization-duration was 3.3 days. Preoperatively, 140 patients (40%) had a suprapubic or transurethral indwelling catheter; they did not differ from patients without preoperative catheter regarding postoperative catheter removal success rate, early postoperative complications, and functional outcomes. Prostate cancer was diagnosed in 43 patients (12.3%). Median postoperative PSA-decline was 6.1 ug/l (89.8% drop). HoLEP is a safe and effective treatment for patients with LUTS or urinary retention and large PV. PV > 100 cm3 was not associated with higher complication rates or successful catheter-removal. Furthermore, functional outcomes were independent of preoperative catheterization.

Influence of regular aspirin intake on PSA values, prostate cancer incidence and overall survival in a prospective screening trial (ERSPC Aarau).

OBJECTIVES: To analyze the influence of aspirin (ASA) intake on PSA values and prostate cancer (PCa) development in a prospective screening study cohort. METHODS: 4314 men from the Swiss section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were included. A transrectal prostate biopsy was performed in men with a PSA level ≥ 3 ng/ml. Mortality data were obtained through registry linkages. PCa incidence and grade, total PSA, free-to-total PSA and overall survival were compared between ASA users and non-users. RESULTS: Median follow-up time was 9.6 years. In 789 men (18.3%) using aspirin [ASA +], the overall PCa incidence was significantly lower (6.8% vs. 9.6%, p = 0.015), but the multivariate Cox regression analysis showed no significant decrease in risk of PCa diagnosis (HR 0.84, p = 0.297). Total PSA values were significantly lower in ASA users for both baseline (1.6 vs. 1.8 ng/ml, p = 0.007) and follow-up visits (1.75 vs. 2.1 ng/ml, p < 0.001). Multivariate Cox regression analysis predicted significantly higher overall mortality risk among ASA users (HR 1.46, p = 0.009). CONCLUSIONS: In our study population, PCa incidence was significantly reduced among patients on aspirin. While we did not observe a statistically significant PCa risk reduction during the follow-up period, we found lower PSA values among ASA users compared to non-users, with a more distinct difference after 4 years of ASA intake, suggesting a cumulative effect and a potential protective association between regular ASA intake and PCa development. As for clinical practice, lowering PSA cutoff values by 0.4 ng/ml could be considered in long-term ASA users to avoid a potential bias towards delayed PCa detection.

Elastography Targeted Prostate Biopsy in Patients under Active Surveillance.

OBJECTIVE: The aim of this study was to examine elastography-based prostate biopsy in prostate cancer (PCa) patients under active surveillance. PATIENTS AND METHODS: We relied on PCa patients who opted for active surveillance and underwent elastography targeted and systematic follow-up biopsy at the Braunschweig Prostate Cancer Center between October 2009 and February 2015. Each prostate sextant was considered as an individual case. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy (ACC) for elastography to predict follow-up biopsy results were analyzed, respectively, and 95 % confidence intervals (CIs) were carried out by using 2000 bootstrapping sample analyses. RESULTS: Overall, 50 men and 300 sextants were identified. Overall, 27 (54%) men and 66 (22%) sextants harbored PCa at follow-up biopsy. Sensitivity, specificity, PPV, NPV, and ACC for elastography to predict follow-up biopsy results were: 19.7 (95% CI: 11.9-27.3), 86.8 (95% CI: 82.7-90.3), 29.6 (95% CI: 14.6-46.0), 79.3 (95% CI: 71.6-86.5), and 72.0% (95% CI: 65.7-78.3), respectively. CONCLUSIONS: We recorded limited reliability of elastography-based prediction of follow-up biopsy results in active surveillance patients. Based on our analyses, we can neither recommend to rely exclusively on elastography-based targeted biopsies nor to delay or to omit follow-up biopsies based on elastography results during active surveillance.

Only Size Matters in Stone Patients: Computed Tomography Controlled Stone-Free Rates after Mini-Percutaneous Nephrolithotomy.

OBJECTIVE: To examine and predicting stone-free rates (SFRs) after minimally invasive-percutaneous nephrolithotomy (mini-PNL) based on computed tomography (CT), instead of X-ray or ultrasound control. PATIENTS AND METHODS: We identified 146 mini-PNL patients with pre- and postoperative CT scans. Patient and stone characteristics were assessed. Stone-free status was defined as ≤3 mm residual fragment after mini-PNL according to postsurgery CT scan. Multivariable logistic regression analyses predicted stone-free status after mini-PNL. RESULTS: Overall, 62 (42.5%) patients achieved stone-free status after mini-PNL. In multivariable analyses, stone size was the only independent predictor for stone-free status (OR 0.9; p = 0.02). Patients with stones > 20 mm were less likely to achieve stone-free status, than those harboring stones 10-20 mm (OR 0.3; p = 0.009). SFRs according to stone size categories (< 10, 10-20, and > 20 mm) were 33.3, 50.5, and 25%. Body mass index (BMI) and stone density (Houndsfield units) were no independent predictors for stone-free status after mini-PNL. CONCLUSIONS: We report lower SFRs than expected. Stone size was the only independent predictor for stone-free status after mini-PNL. Patients with larger stones need to be informed about high risk of additional interventions. High BMI and high stone density do not represent a barrier for stone-free status after mini-PNL.

Limitations of Elastography Based Prostate Biopsy.

PURPOSE: The role of elastography in patients initially and at repeat prostate biopsy is still indeterminate. The existing literature is sparse and controversial. MATERIALS AND METHODS: We studied patients who underwent elastography based and systematic biopsy between October 2009 and February 2015 at Braunschweig Prostate Cancer Center. Patients were separated according to first vs repeat biopsy setting. Each prostate sextant was considered an individual case. The sensitivity, specificity, positive and negative predictive values, and accuracy of elastography to predict biopsy results were analyzed. The 95% CIs were determined by bootstrapping analysis of 2,000 samples. RESULTS: Overall 679 men and a total of 4,074 sextants were identified. Of the 679 men 160 (23.6%) underwent first biopsy and 519 (76.4%) underwent repeat biopsy. In the 160 men at first biopsy sensitivity was 18.0% (95% CI 14.5-21.3), specificity was 87.7% (95% CI 85.3-89.9), positive predictive value was 36.6% (95% CI 28.4-45.4), negative predictive value was 73.0% (95% CI 67.5-77.9) and accuracy was 67.9% (95% CI 63.4-72.2). Results in 519 men (76.4%) at repeat biopsy were 19.8% (95% CI 16.0-23.7), 90.9% (95% CI 89.9-91.9), 20.1% (95% CI 15.8-24.8), 90.7% (95% CI 89.0-92.3) and 83.5% (95% CI 81.6-85.2), respectively. CONCLUSIONS: We found limited reliability of elastography prediction at prostate biopsy in patients at first and repeat biopsies. Based on our analyses we cannot recommend a variation of well established systematic biopsy patterns or a decrease in biopsy cores based on elastography.

A positive family history as a risk factor for prostate cancer in a population-based study with organised prostate-specific antigen screening: results of the Swiss European Randomised Study of Screening for Prostate Cancer (ERSPC, Aarau).

OBJECTIVE: To assess the value of a positive family history (FH) as a risk factor for prostate cancer incidence and grade among men undergoing organised prostate-specific antigen (PSA) screening in a population-based study. SUBJECTS AND METHODS: The study cohort comprised all attendees of the Swiss arm of the European Randomised Study of Screening for Prostate Cancer (ERSPC) with systematic PSA level tests every 4 years. Men reporting first-degree relative(s) diagnosed with prostate cancer were considered to have a positive FH. Biopsy was exclusively PSA triggered at a PSA level threshold of 3 ng/mL. The primary endpoint was prostate cancer diagnosis. Kaplan-Meier and Cox regression analyses were used. RESULTS: Of 4 932 attendees with a median (interquartile range, IQR) age of 60.9 (57.6-65.1) years, 334 (6.8%) reported a positive FH. The median (IQR) follow-up duration was 11.6 (10.3-13.3) years. Cumulative prostate cancer incidence was 60/334 (18%, positive FH) and 550/4 598 (12%, negative FH) [odds ratio 1.6, 95% confidence interval (CI) 1.2-2.2, P = 0.001). In both groups, most prostate cancer diagnosed was low grade. There were no significant differences in PSA level at diagnosis, biopsy Gleason score or Gleason score on pathological specimen among men who underwent radical prostatectomy between both groups. On multivariable analysis, age (hazard ratio [HR] 1.04, 95% CI 1.02-1.06), baseline PSA level (HR 1.13, 95% CI 1.12-1.14), and FH (HR 1.6, 95% CI 1.24-2.14) were independent predictors for overall prostate cancer incidence (all P < 0.001). Only baseline PSA level (HR 1.14, 95% CI 1.12-1.16, P < 0.001) was an independent predictor of Gleason score ≥7 prostate cancer on prostate biopsy. The proportion of interval prostate cancer diagnosed in-between the screening rounds was not significantly different. CONCLUSION: Irrespective of the FH status, the current PSA-based screening setting detects the majority of aggressive prostate cancers and missed only a minority of interval cancers with a 4-year screening algorithm. Our results suggest that men with a positive FH are at increased risk of low-grade but not aggressive prostate cancer.

True targeting-derived prostate biopsy: HistoScanning™ remained inadequate despite advanced technical efforts.

PURPOSE: To verify the reliability of HistoScanning™-based, true targeting (TT)-derived prostate biopsy. METHODS: We relied on 40 patients suspicious for prostate cancer who underwent standard and TT-derived prostate biopsy. Sensitivity, specificity, positive predictive value, negative predictive value and the area under the curve (AUC) were assessed for the prediction of biopsy results per octant by HistoScanning™, using different HistoScanning™ signal volume cutoffs (>0, >0.2 and >0.5 ml). RESULTS: Overall, 319 octants were analyzed. Of those, 64 (20.1 %) harbored prostate cancer. According to different HistoScanning™ signal volume cutoffs (>0, >0.2 and >0.5 ml), the AUCs for predicting biopsy results were: 0.51, 0.51 and 0.53, respectively. Similarly, the sensitivity, specificity, positive predictive and negative predictive values were: 20.7, 78.2, 17.4 and 81.6 %; 20.7, 82.0, 20.3 and 82.3 %; and 12.1, 94.6, 33.3 and 82.9 %, respectively. CONCLUSIONS: Prediction of biopsy results based on HistoScanning™ signals and TT-derived biopsies was unreliable. Moreover, the AUC of TT-derived biopsies was low and did not improve when additional signal volume cutoffs were applied (>0.2 and >0.5 ml). We cannot recommend a variation of well-established biopsy standards or reduction in biopsy cores based on HistoScanning™ signals.

Is further screening of men with baseline PSA < 1 ng ml(-1) worthwhile? The discussion continues-Results of the Swiss ERSPC (Aarau).

Recent studies indicate frequent early PSA retesting unrelated of men's baseline PSA, which increases the harms of early detection especially among men with low PSA. The current study investigates the PCa incidence among men with baseline PSA <1.0 ng ml(-1) in order to adjust retest intervals for more targeted early detection. Between 1998 and 2012, 2,416 men with baseline PSA <1.0 ng ml(-1) were prospectively observed. Primary endpoint was PCa diagnosis. Negative predictive value (NPV) and number needed to screen (NNS) to detect one PCa were calculated. During a median follow-up time of 12.1 years, 54 (2.2%) PCa were diagnosed with n = 26 (48.1%) among men with baseline PSA of 0.75 ≤ 1.0 ng ml(-1) (upper baseline PSA quartile). The 10-year probability of being diagnosed with PCa increased significantly from 0.19% (baseline PSA < 0.40 ng ml(-1) ) to 2.0% (baseline PSA 0.40 ≤ 0.56 ng ml(-1) ), 2.5% (baseline PSA 0.56 ≤ 0.75 ng ml(-1) ) over 4.4% (baseline PSA 0.75 ≤ 1.0 ng ml(-1) ) (all p values <0.0001), respectively. The frequency of Gleason ≥7 PCa increased from 1 (0.17%) to 8 (1.4%), 5 (0.8) over 11 (1.8%) in these groups. The 8-year NPV for Gleason ≥ 7 PCa were 99.8 (baseline PSA < 0.40 ng ml(-1) ), 99.8 (baseline PSA 0.40 ≤ 0.56 ng ml(-1) ), 100 (baseline PSA 0.56 ≤ 0.75 ng ml(-1) ) and 99.5 (baseline PSA 0.75 ≤ 1.0 ng ml(-1) ), respectively. During 12 years, the numbers were 99.8, 98.6, 99.2, and 98.2, respectively. Therefore, due to the very low rate of Gleason ≥ 7 PCa, further screening might be omitted in men with baseline PSA < 0.4 ng ml(-1) . Between 0.4 and 1.0 ng ml(-1) , an 8-year interval can be discussed.

Influence of metformin use on PSA values, free-to-total PSA, prostate cancer incidence and grade and overall survival in a prospective screening trial (ERSPC Aarau).

PURPOSE: To analyze the effect of the oral antidiabetic drug metformin on PSA level, free-to-total PSA ratio (f/t-ratio), PCa incidence and grade as well as mortality in men participating in a population-based screening trial. METHODS: Data from 4,314 men aged 55-70 years from a population-based PSA-screening trial (ERSPC Aarau) were analyzed. Information on metformin exposure was obtained by a self-administered questionnaire. Serum PSA threshold at ≥3 ng/ml triggered prostate biopsy. Data on PCa incidence and mortality were obtained through registry linkages. RESULTS: Median follow-up time was 7.6 years. Mean age at baseline was 65.5 years (±SD 4.4). In all, n = 150 (3.5 %) men used metformin [metf+]. Mean baseline PSA levels were comparable between both groups ([metf+] 1.6 ng/ml ± 2.4 vs. [metf-] 1.8ug/l ± 2.2, p = 0.4) while f/t-ratio was slightly higher in metformin users ([metf+] 30.7 % ± 10.9 vs. [metf-] 27.3 % ± 10.9, p = 0.01). Overall, n = 372 (8.6 %) PCa cases were detected. Neither cumulative PCa incidence (n = 11; 7.3 % [metf+] vs. n = 361 8.7 % [metf-]; p = 0.5) nor d`Amico risk groups were significantly different between both groups. One man in each group (metf+ 0.7 % and metf- 0.02 %) died from PCa (p < 0.0001), respectively. All-cause mortality was significantly higher among met + compared to met- (adjusted OR 2.50, 95 %CI 1.59-3.82; p = 0.0001). CONCLUSION: No significant differences in PSA levels or PCa incidence and grade were observed. The slightly higher f/t-ratio did not result in lower PCa detection rate. Metformin users were at significantly higher risk of all-cause mortality. The relatively small number of men on metformin is a main limitation of the study.

Controversial evidence for the use of HistoScanning™ in the detection of prostate cancer.

INTRODUCTION: Given the growing body of literature since first description of HistoScanning™ in 2008, there is an unmet need for a contemporary review. EVIDENCE ACQUISITION: Studies addressing HistoScanning™ in prostate cancer (PCa) were considered to be included in the current review. To identify eligible reports, we relied on a bibliographic search of PubMed database conducted in January 2015. EVIDENCE SYNTHESIS: Twelve original articles were available to be included in the current review. The existing evidence was reviewed according to the three following topics: prediction of final pathology at radical prostatectomy, prediction of disease stage and application at prostate biopsy. CONCLUSIONS: High sensitivity and specificity for HistoScanning™ to predict cancer foci ≥0.5 ml at final pathology were achieved in the pilot study. These results were questioned, when HistoScanning™ derived tumor volume does not correlate with final pathology results. Additionally, HistoScanning™ was not able to provide reliable staging information according to neither extraprostatic extension, nor seminal vesicle invasion prior to radical prostatectomy. Controversy data also exist according to the use of HistoScanning™ at prostate biopsy. Specifically, most encouraging results were recorded in a small patient cohort. Conversely, HistoScanning™ achieved poor prediction of positive biopsies, when relying on larger studies. Finally, the combination of HistoScanning™ and conventional ultrasound achieved lower detection rates than systematic biopsy. Currently, evidence is at best weak and questions whether HistoScanning™ might improve the detection of PCa.

Differences among men on active surveillance for very low-risk prostate cancer detected through population-based versus opportunistic prostate-specific antigen-screening.

INTRODUCTION: Very low-risk prostate cancer (PCa) is being increasingly managed by active surveillance (AS). Our aim was to assess the influence of the origin of diagnosis on PCa characteristics and treatment rates among men with very low-risk PCa in our prospective AS cohort. METHODS: Overall, 191 men with very low-risk PCa fulfilling Epstein-criteria underwent protocol-based AS. These men originated either from the prospective population-based screening program (P-AS) or were diagnosed by opportunistic screening (O-AS). RESULTS: Overall, n = 86 (45.0%) originated from the P-AS group, whereas n = 105 (55.0%) from the O-AS group. On univariate Cox regression analysis, age (HR 0.96, 95% CI 0.92-1.00; p = 0.05), origin of diagnosis (HR 0.72, 95% CI 0.41-1.28; p = 0.001), number of positive cores (HR 2.15, 95% CI 1.18-3.90; p = 0.01) and maximum core involvement (HR 1.03, 95% CI 0.99-1.05; p = 0.05) were predictors for treatment necessity. On multivariate analysis, age (HR 0.95, 95% CI 0.89-0.99; p = 0.05), number of positive cores (HR 2.07, 95% CI 1.10-3.88; p = 0.02), maximum core involvement (HR 1.03, 95% CI 1.00-1.06; p = 0.04) but not origin of diagnosis were independent predictors for treatment necessity. Four men developed biochemical recurrence (all from O-AS group [p = 0.05]). CONCLUSION: The origin of PCa diagnosis in men undergoing AS had no influence on disease progression and treatment necessity.

PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer.

BACKGROUND: Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE). OBJECTIVE: This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population. DESIGN, SETTING, AND PARTICIPANTS: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume ≥35 cm3. Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI. RESULTS AND LIMITATIONS: The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) ≥2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%]. CONCLUSIONS: In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI. PATIENT SUMMARY: Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies.

Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management.

Introduction: Numerous factors are intersecting in healthcare resulting in an increased focus on new tools and methods for managing care in patients' homes. Remote patient monitoring (RPM) is an option to provide care at home and maintain a connection between patients and providers to address ongoing medical issues. Methods: Mayo Clinic developed a nurse-led RPM program for disease and post-procedural management to improve patient experience, clinical outcomes, and reduce health care utilization by more directly engaging patients in their health care. Enrolled patients are sent a technology package that includes a digital tablet and peripheral devices for the collection of symptoms and vital signs. The data are transmitted from to a hub integrated within the electronic health record. Care team members coordinate patient needs, respond to vital sign alerts, and utilize the data to inform and provide individualized patient assessment, patient education, medication management, goal setting, and clinical care planning. Results: Since its inception, the RPM program has supported nearly 22,000 patients across 17 programs. Patients who engaged in the COVID-19 RPM program experienced a significantly lower rate of 30-day, all-cause hospitalization (13.7% vs. 18.0%, P = 0.01), prolonged hospitalization >7 days (3.5% vs. 6.7%, P = 0.001), intensive care unit (ICU) admission (2.3% vs. 4.2%, P = 0.01), and mortality (0.5% vs. 1.7%, P = 0.01) when compared with those enrolled and unengaged with the technology. Patients with chronic conditions who were monitored with RPM upon hospital discharge were significantly less likely to experience 30-day readmissions (18.2% vs. 23.7%, P = 0.03) compared with those unmonitored. Ninety-five percent of patients strongly agreed or agreed they were likely to recommend RPM to a friend or family member. Conclusions: The Mayo Clinic RPM program has generated positive clinical outcomes and is satisfying for patients. As technology advances, there are greater opportunities to enhance this clinical care model and it should be extended and expanded to support patients across a broader spectrum of needs. This report can serve as a framework for health care organizations to implement and enhance their RPM programs in addition to identifying areas for further evolution and exploration in developing RPM programs of the future.

Prospective evaluation of smartwatch-enabled detection of left ventricular dysfunction.

Although artificial intelligence (AI) algorithms have been shown to be capable of identifying cardiac dysfunction, defined as ejection fraction (EF) ≤ 40%, from 12-lead electrocardiograms (ECGs), identification of cardiac dysfunction using the single-lead ECG of a smartwatch has yet to be tested. In the present study, a prospective study in which patients of Mayo Clinic were invited by email to download a Mayo Clinic iPhone application that sends watch ECGs to a secure data platform, we examined patient engagement with the study app and the diagnostic utility of the ECGs. We digitally enrolled 2,454 unique patients (mean age 53 ± 15 years, 56% female) from 46 US states and 11 countries, who sent 125,610 ECGs to the data platform between August 2021 and February 2022; 421 participants had at least one watch-classified sinus rhythm ECG within 30 d of an echocardiogram, of whom 16 (3.8%) had an EF ≤ 40%. The AI algorithm detected patients with low EF with an area under the curve of 0.885 (95% confidence interval 0.823-0.946) and 0.881 (0.815-0.947), using the mean prediction within a 30-d window or the closest ECG relative to the echocardiogram that determined the EF, respectively. These findings indicate that consumer watch ECGs, acquired in nonclinical environments, can be used to identify patients with cardiac dysfunction, a potentially life-threatening and often asymptomatic condition.

Adherence to the EAU Guideline Recommendations for Local Tumor Treatment in Penile Cancer: Results of the European PROspective Penile Cancer Study Group Survey (E-PROPS).

INTRODUCTION: Penile cancer (PeCa) is an orphan disease in European countries. The current guidelines are predominantly based on retrospective studies with a low level of evidence. In our study, we aimed to identify predictors for guideline-conform treatment and hypothesize that reference centers for PeCa and physicians' experience promote guideline compliance and therefore correct local tumor therapy. METHODS: This study is part of the European PROspective Penile Cancer Study (E-PROPS), an international collaboration group evaluating therapeutic management for PeCa in Central Europe. For this module, a 14-item-survey was developed and sent to 681 urologists in 45 European centers. Three questions focused on therapeutic decisions for PeCa in clinical stage Tis, Ta-T1a, and T1b. Four questions addressed potential personal confounders. Survey results were analyzed by bootstrap-adjusted stepwise multivariate linear regression analysis to identify predictors for EAU guideline-conform local treatment of PeCa. RESULTS: For local therapy of cTis 80.4% recommended guideline-conform treatment, for cTa-cT1a 87.3% and for cT1b 59.1%. In total, 42.4% chose a correct approach in all tumor stages. The number of PeCa patients treated at the hospital, a higher level of training of the physicians, resource-based answering and the option of penile-sparing surgery offered at the hospital matched with giving guideline-conform recommendations and thus accurate local tumor treatment. CONCLUSION: Patients with PeCa are best treated by experienced physicians, in centers with a high number of cases, which also offer a wide range of local tumor therapy. This could be offered in reference centers.

A Multi-institutional Analysis of Perioperative Outcomes in 106 Men Who Underwent Radical Prostatectomy for Distant Metastatic Prostate Cancer at Presentation.

BACKGROUND: Current trials are investigating radical intervention in men with metastatic prostate cancer. However, there is a lack of safety data for radical prostatectomy as therapy in this setting. OBJECTIVE: To examine perioperative outcomes and short-term complications after radical prostatectomy for locally resectable, distant metastatic prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: A retrospective case series from 2007 to 2014 comprising 106 patients with newly diagnosed metastatic (M1) prostate cancer from the USA, Germany, Italy, and Sweden. INTERVENTION: Radical prostatectomy and extended pelvic lymphadenectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Descriptive statistics were used to present margin status, continence, and readmission, reoperation, and overall complication rates at 90 d, as well as for 21 specific complications. Kaplan-Meier plots were used to estimate survival function. Intercenter variability and M1a/ M1b subgroups were examined. RESULTS AND LIMITATIONS: Some 79.2% of patients did not suffer any complications; positive-margin (53.8%), lymphocele (8.5%), and wound infection (4.7%) rates were higher in our cohort than in a meta-analysis of open radical prostatectomy performed for standard indications. At a median follow-up of 22.8 mo, 94/106 (88.7%) men were still alive. The study is limited by its retrospective design, differing selection criteria, and short follow-up. CONCLUSIONS: Radical prostatectomy for men with locally resectable, distant metastatic prostate cancer appears safe in expert hands for meticulously selected patients. Overall and specific complication rates related to the surgical extirpation are not more frequent than when radical prostatectomy is performed for standard indications, and the use of extended pelvic lymphadenectomy in all of this cohort compared to its selective use in localized/locally advanced prostate cancer accounts for any extra morbidity. PATIENT SUMMARY: Men presenting with advanced prostate cancer that has spread beyond the prostate are increasingly being considered for treatments directed at the prostate itself. On the basis of results for our international series of 106 men, surgery appears reasonably safe in this setting for certain patients.