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BACKGROUND: The Oncotype DX Genomic Prostate Score (ODX-GPS) is a gene expression assay that predicts disease aggressiveness. The objective of this study was to identify sociodemographic and regional factors associated with ODX-GPS uptake. METHODS: Data from Surveillance Epidemiology and End Results registries on men with localized prostate cancer with a Gleason score of 3 + 3 or 3 + 4, PSA ≤20 ng/mL, and stage T1c to T2c disease from 2013 through 2017 were linked with ODX-GPS data. Census-tract level neighborhood socioeconomic status (nSES) quintiles were constructed using a composite socioeconomic score. Multivariable logistic regression was used to estimate the associations of ODX-GPS uptake with age at diagnosis, race and ethnicity, nSES, geographic region, insurance type, and marital status, accounting for National Comprehensive Cancer Network risk group, year of diagnosis, and clustering by census tract. RESULTS: Among 111,434 eligible men, 5.5% had ODX-GPS test uptake. Of these, 78.3% were non-Hispanic White, 9.6% were Black, 6.7% were Hispanic, and 3.6% were Asian American. Black men had the lowest odds of ODX-GPS uptake (odds ratio, 0.70; 95% confidence interval [CI], 0.63-0.76). Those in the highest versus lowest quintile of nSES were 1.64 times more likely (95% CI, 1.38-2.94) to have ODX-GPS uptake. The odds of ODX-GPS uptake were statistically significantly higher among men residing in the Northeast, West, and Midwest compared to the South. CONCLUSIONS: Disparities in ODX-GPS uptake by race, ethnicity, nSES, and geographical region were identified. Concerted efforts should be made to ensure that this clinical test is equitably available.
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BACKGROUND: The association between body mass index (BMI) and mortality among individuals with renal cell cancer (RCC) is debated, with some observational studies suggesting a lower mortality associated with higher BMI. However, methodological issues such as confounding and reverse causation may bias these findings. Using BMI-associated genetic variants can avoid these biases and generate more valid estimates. METHODS: In this prospective cohort study, we included 1264 RCC patients (446 deaths) from the UK Biobank. We created a BMI polygenic score (PGS) based on 336 BMI-associated genetic variants. The association between the PGS and mortality (all-cause and RCC-specific) was evaluated by logistic regression (all RCC cases) and Cox regression (906 incident cases). For comparison, the associations of measured pre-diagnostic BMI and waist-to-hip ratio (WHR) with mortality were quantified by Cox regression among incident cases. We stratified these analyses by time between anthropometric measurement and RCC diagnosis to assess the influence of reverse causation. RESULTS: We did not observe an association between the BMI PGS and all-cause mortality among RCC patients (hazard ratio (HR) per SD increase = 0.98, 95% CI: 0.88,1.10). No association was found for pre-diagnostic BMI (HR per 5 kg/m2 increase = 0.93, 95% CI: 0.83,1.04) or WHR (HR per 0.1 increase = 0.97, 95% CI: 0.83,1.13) with mortality. In patients with anthropometrics measured within 2 years before RCC diagnosis, we observed associations of higher BMI (HR per 5 kg/m2 = 0.76, 95% CI: 0.59,0.98) and WHR (HR = 0.67 per 0.1 increase, 95% CI: 0.45,0.98) with a lower risk of death. Similar patterns were observed for RCC-specific mortality. CONCLUSION: We found no association between either genetic variants for high BMI or measured pre-diagnostic body adiposity and mortality among RCC patients, and our results suggested a role for reverse causation in the association of obesity with lower mortality. Future studies should be designed carefully to produce unbiased estimates that account for confounding and reverse causation.
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PURPOSE: The objective of this study is to analyze characteristics of recurrent acute urinary retention (AUR) in patients with benign prostatic hyperplasia (BPH), utilizing a population based data set. Also, we sought to report on how AUR was treated, specifically regarding the need and length of catheterization and types of procedures utilized for mitigation. MATERIALS & METHODS: A retrospective observational cohort study was performed using Optum's deidentified Clinformatics® Data Mart Database. We compared two groups, BPH patients with AUR (n = 180,737) and BPH patients without AUR (n = 1,139,760) from January 1, 2003 to December 31, 2017. Also, we analyzed the factors affecting the development of multiple episodes of AUR through age-adjusted multivariate analysis. RESULTS: In contrast to the 47.7% of patients who had a single AUR episode, 33.5% of AUR patients developed 3 or more subsequent episodes of retention. For age matched patients, the risks of additional episodes of retention increase significantly with older age, Caucasian race, diabetes, neurologic conditions, or low income. Overall, the rate of BPH surgery in AUR patients over the study period decreased and the most common procedure was transurethral resection of the prostate. CONCLUSIONS: Risk factors for multiple episodes of AUR included age (60 and older), Caucasian race, lower income socioeconomic status, diabetes, and neurological disorders. Patients with a high probability of developing recurrent episodes of AUR are recommended to receive preemptive BPH medication before such AUR occurrences. Also, more expeditious surgical treatment should be considered rather than temporary catheterization when AUR occurs.
Subject(s)
Prostatic Hyperplasia , Transurethral Resection of Prostate , Urinary Retention , Male , Humans , United States/epidemiology , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/epidemiology , Prostatic Hyperplasia/drug therapy , Urinary Retention/epidemiology , Urinary Retention/etiology , Retrospective Studies , Transurethral Resection of Prostate/adverse effects , Risk Factors , Acute DiseaseABSTRACT
BACKGROUND: Kidney cancer incidence demonstrates significant geographic variation suggesting a role for environmental risk factors. This study sought to evaluate associations between groundwater exposures and kidney cancer incidence. METHODS: The authors identified constituents from 18,506 public groundwater wells in all 58 California counties measured in 1996-2010, and obtained county-level kidney cancer incidence data from the California Cancer Registry for 2003-2017. The authors developed a water-wide association study (WWAS) platform using XWAS methodology. Three cohorts were created with 5 years of groundwater measurements and 5-year kidney cancer incidence data. The authors fit Poisson regression models in each cohort to estimate the association between county-level average constituent concentrations and kidney cancer, adjusting for known risk factors: sex, obesity, smoking prevalence, and socioeconomic status at the county level. RESULTS: Thirteen groundwater constituents met stringent WWAS criteria (a false discovery rate <0.10 in the first cohort, followed by p values <.05 in subsequent cohorts) and were associated with kidney cancer incidence. The seven constituents directly related to kidney cancer incidence (and corresponding standardized incidence ratios) were chlordane (1.06; 95% confidence interval [CI], 1.02-1.10), dieldrin (1.04; 95% CI, 1.01-1.07), 1,2-dichloropropane (1.04; 95% CI, 1.02-1.05), 2,4,5-TP (1.03; 95% CI, 1.01-1.05), glyphosate (1.02; 95% CI, 1.01-1.04), endothall (1.02; 95% CI, 1.01-1.03), and carbaryl (1.02; 95% CI, 1.01-1.03). Among the six constituents inversely related to kidney cancer incidence, the standardized incidence ratio furthest from the null was for bromide (0.97; 95% CI, 0.94-0.99). CONCLUSIONS: This study identified several groundwater constituents associated with kidney cancer. Public health efforts to reduce the burden of kidney cancer should consider groundwater constituents as environmental exposures that may be associated with the incidence of kidney cancer.
Subject(s)
Carcinoma, Renal Cell , Groundwater , Kidney Neoplasms , Humans , Incidence , Environmental Exposure/adverse effects , Kidney Neoplasms/epidemiologyABSTRACT
BACKGROUND: Patients diagnosed with low-risk prostate cancer (PCa) are confronted with a difficult decision regarding whether to undergo definitive treatment or to pursue an active surveillance protocol. This is potentially further complicated by the possibility that patients and physicians may place different value on factors that influence this decision. We conducted a qualitative investigation to better understand patient and physician perceptions of factors influencing treatment decisions for low-risk PCa. METHODS: Semi-structured interviews were conducted among 43 racially and ethnically diverse patients diagnosed with low-risk PCa, who were identified through a population-based cancer registry, and 15 physicians who were selected to represent a variety of practice settings in the Greater San Francisco Bay Area. RESULTS: Patients and physicians both described several key individual (e.g., clinical) and interpersonal (e.g., healthcare communications) factors as important for treatment decision-making. Overall, physicians' perceptions largely mirrored patients' perceptions. First, we observed differences in treatment preferences by age and stage of life. At older ages, there was a preference for less invasive options. However, at younger ages, we found varying opinions among both patients and physicians. Second, patients and physicians both described concerns about side effects including physical functioning and non-physical considerations. Third, we observed differences in expectations and the level of difficulty for clinical conversations based on information needs and resources between patients and physicians. Finally, we discovered that patients and physicians perceived patients' prior knowledge and the support of family/friends as facilitators of clinical conversations. CONCLUSIONS: Our study suggests that the gap between patient and physician perceptions on the influence of clinical and communication factors on treatment decision-making is not large. The consensus we observed points to the importance of developing relevant clinical communication roadmaps as well as high quality and accessible patient education materials.
Subject(s)
Physicians , Prostatic Neoplasms , Male , Humans , Decision Making , Prostatic Neoplasms/therapy , Physician-Patient Relations , Qualitative ResearchABSTRACT
OBJECTIVES: To address the association of perioperative surgical checklist across variable surgical expertise with transurethral resection of bladder tumour (TURBT) accuracy and oncological outcomes in non-muscle-invasive bladder cancer. PATIENTS AND METHODS: We relied on our prospective collaborative database of patients treated with TURBT between 2012 and 2017. Surgical experience was stratified into three groups: resident vs young vs expert consultants. The association of surgical experience with detrusor muscle (DM) presence and adherence to the standardised peri-procedural nine-items TURBT checklist was evaluated with logistic regression models. A Cox regression model was used to investigate the association of surgical experience with recurrence-free survival (RFS). RESULTS: A total of 503 patients were available for analysis. TURBT was performed by expert consultants in 265 (52.7%) patients, by young consultants in 149 (29.6%) and by residents in 89 (17.7%). Residents were more likely to have DM in the TURBT specimen than expert consultants (odds ratio [OR] 1.75, 95% confidence interval [CI] 1.03-2.99, P = 0.04). Conversely, no differences in DM presence were seen between young vs expert consultants (OR 1.09, 95% CI 0.71-1.70, P = 0.69). The median checklist completion rate was higher for both residents and young consultants when compared to experts' counterparts (56% and 56% vs 44%, P = 0.009). When focusing on patients receiving a second-look TURBT, the persistent disease was associated with resident status (OR 4.24, 95% CI 1.14-17.70, P = 0.037) at initial TURBT. Surgical experience was not associated with 5-years RFS. CONCLUSION: Surgeon's experience in the case of adequate perioperative surgical checklist implementation was inversely associated with the presence of DM in the specimen but directly linked to higher probability of persistent disease at re-TURBT, although no 5-year RFS differences were noted.
Subject(s)
Urinary Bladder Neoplasms , Urology , Humans , Prospective Studies , Checklist , Quality Indicators, Health Care , Transurethral Resection of Bladder , Urinary Bladder Neoplasms/surgery , Urinary Bladder Neoplasms/pathology , CystectomyABSTRACT
OBJECTIVES: To examine the effects of age, sex, and type of COVID-19 vaccine on urological complications after vaccination with COVID-19. MATERIALS AND METHODS: We used the Vaccine Adverse Event Reporting System (VAERS) data from December 2020 to August 2022 to analyze urological symptoms post-vaccination adverse events (AEs) associated with COVID-19 vaccines authorized for the U.S. POPULATION: We collected AEs after 1-2 dose vaccination in VAERS, but not those after an additional booster shot. Age was divided into three groups (< 18 years, 18-64 years, and > 64 years), and compared incidence of AEs after vaccination with either mRNA vaccine (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) or a viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) as reported in VAERS data. RESULTS: Cumulative incidence rates (CIRs) of LUTS, voiding symptom, storage symptom, infection, and hematuria were 0.057, 0.282, 0.223, 1.245, and 0.214, respectively. By gender, CIRs OF LUTS, storage symptom, and infection were statistically significantly higher in women, whereas CIRs of voiding symptom and hematuria were statistically significantly higher in men. CIRs of AEs per 100,000 in age groups of < 18 years, 18-64 years, and > 64 years were 0.353, 1.403, and 4.067, respectively. All AE types except for voiding symptom displayed the highest CIRs in the Moderna vaccine group. CONCLUSIONS: Based on an updated analysis of available data, the prevalence of urologic complications following administration of COVID-19 vaccines is low. However, specific urologic complications such as gross hematuria are not low in incidence.
Subject(s)
COVID-19 Vaccines , COVID-19 , Male , Female , Humans , Adolescent , COVID-19 Vaccines/adverse effects , Ad26COVS1 , BNT162 Vaccine , Hematuria/epidemiology , Hematuria/etiology , COVID-19/epidemiology , COVID-19/prevention & controlABSTRACT
BACKGROUND. Bosniak classification system version 2019 (v2019) recommends that class IIF masses undergo follow-up imaging at 6 months, 12 months, and then annually for 5 years. The frequency and timing of upgrade on follow-up imaging are incompletely understood. OBJECTIVE. The purpose of this article is to describe the temporal evolution of Bosniak v2019 class IIF cystic renal masses, with attention to outcomes at 6-month follow-up, the time to class upgrade, and malignant histologic diagnoses. METHODS. This retrospective study included 219 patients (91 women, 128 men; median age, 72 years) with 246 localized class IIF masses from January 2005 to June 2022. Patients underwent both a baseline and at least one follow-up renal-mass protocol contrast-enhanced CT or MRI examination. Two radiologists evaluated masses at all follow-up time points to categorize masses as downgraded (class I or II), stable (localized class IIF), or upgraded (class III or IV, solid, or category T3a, N1, or M1 or higher disease); a third radiologist resolved discrepancies. Incidence rate of upgrade was determined. Histopathologic outcomes were assessed for resected masses. RESULTS. Median follow-up was 28.4 months (IQR, 13.7-59.4 months). At 6-month follow-up, five (2%) masses were downgraded, 241 (98%) were stable, and none were upgraded. On the basis of final follow-up, 14 (6%) masses were downgraded, 223 (91%) were stable, and nine (4%) were upgraded. All upgrade events entailed a class increase to III (n = 7) or IV (n = 2); no mass became solid or developed T3, N1, or M1 disease. Among the nine upgraded masses, median time to upgrade was 53.5 months (IQR, 23.2-63.7 months). Incidence rate of upgrade was 3.006 per 100,000 person-days (95% CI, 1.466-5.516). Ten masses were resected; histopathology was benign in six and malignant in four. Of the four malignant masses, one was upgraded to class III after 15 months of preoperative follow-up imaging, and three remained class IIF on preoperative follow-up imaging. No resected malignant mass developed postoperative recurrence. CONCLUSION. Bosniak v2019 class IIF masses are unlikely to represent aggressive malignancy; only 4% were upgraded over time and never on initial 6-month follow-up. CLINICAL IMPACT. The currently recommended initial 6-month follow-up imaging examination for class IIF masses is of questionable clinical utility.
Subject(s)
Kidney Diseases, Cystic , Kidney Neoplasms , Male , Humans , Female , Aged , Retrospective Studies , Kidney Diseases, Cystic/diagnostic imaging , Tomography, X-Ray Computed/methods , Kidney/pathology , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/surgeryABSTRACT
BACKGROUND. Active surveillance is increasingly used as first-line management for localized renal masses. Triggers for intervention primarily reflect growth kinetics, which have been poorly investigated for cystic masses defined by the Bosniak classification version 2019 (v2019). OBJECTIVE. The purpose of this study was to determine growth kinetics and incidence rates of progression of class III and IV cystic renal masses, as defined by the Bosniak classification v2019. METHODS. This retrospective study included 105 patients (68 men, 37 women; median age, 67 years) with 112 Bosniak v2019 class III or IV cystic renal masses on baseline renal mass protocol CT or MRI examinations performed from January 2005 to September 2021. Mass dimensions were measured. Progression was defined as any of the following: linear growth rate (LGR) of 5 mm/y or greater (representing the clinical guideline threshold for intervention), volume doubling time less than 1 year, T category increase, or N1 or M1 disease. Class III and IV masses were compared. Time to progression was estimated using Kaplan-Meier curve analysis. RESULTS. At baseline, 58 masses were class III and 54 were class IV. Median follow-up was 403 days. Median LGR for class III masses was 0.0 mm/y (interquartile range [IQR], -1.3 to 1.8 mm/y) and for class IV masses was 2.3 mm/y (IQR, 0.0-5.7 mm/y) (p < .001). LGR was at least 5 mm/y in four (7%) class III masses and 15 (28%) class IV masses (p = .005). Two patients, both with class IV masses, developed distant metastases. Incidence rate of progression for class III masses was 11.0 (95% CI, 4.5-22.8) and for class IV masses 73.6 (95% CI, 47.8-108.7) per 100,000 person-days of follow-up. Median time to progression was undefined for class III masses given the small number of progression events and 710 days for class IV masses. Hazard ratio of progression for class IV relative to class III masses was 5.1 (95% CI, 2.5-10.8; p < .001). CONCLUSION. During active surveillance of cystic masses evaluated using the Bosniak classification v2019, class IV masses grew faster and were more likely to progress than class III masses. CLINICAL IMPACT. In comparison with current active surveillance guidelines that treat class III and IV masses similarly, future iterations may incorporate relatively more intensive surveillance for class IV masses.
Subject(s)
Kidney Diseases, Cystic , Kidney Neoplasms , Aged , Female , Humans , Kidney/pathology , Kidney Diseases, Cystic/diagnostic imaging , Kidney Diseases, Cystic/pathology , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/pathology , Kinetics , Male , Retrospective Studies , Tomography, X-Ray Computed/methodsABSTRACT
Herein, we analyze answers achieved, open questions, and future perspectives regarding the analysis of the pathogenetic variants (PV) of DNA damage response (and repair) (DDR) genes in prostate cancer (PC) patients. The incidence of PVs in homologous recombination repair (HRR) genes among men with metastatic PC varied between 11% and 33%, which was significantly higher than that in non-metastatic PC, and BRCA2 mutations were more frequent when compared to other DDR genes. The determination of the somatic or germline PVs of BRCA2 was able to define a tailored therapy using PARP inhibitors in metastatic castration-resistant prostate cancer (mCRPC) progression after first-line therapy, with significant improvements in the radiologic progression-free survival (rPFS) and overall survival (OS) rates. We propose testing all metastatic PC patients for somatic and germline HRR mutations. Somatic determination on the primary site or on historic paraffin preparations with a temporal distance of no longer than 5 years should be preferred over metastatic site biopsies. The prognostic use of DDR PVs will also be used in selected high-risk cases with non-metastatic stages to better arrange controls and therapeutic primary options. We anticipate that the use of poly-ADP-ribose polymerase (PARP) inhibitors in hormone-sensitive prostate cancer (HSPC) and in combination with androgen receptor signaling inhibitors (ARSI) will be new strategies.
Subject(s)
Prostatic Neoplasms, Castration-Resistant , Prostatic Neoplasms , Male , Humans , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/genetics , Prostatic Neoplasms/pathology , Germ-Line Mutation , Poly(ADP-ribose) Polymerase Inhibitors/pharmacology , Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use , Progression-Free Survival , BRCA1 Protein/genetics , Prostatic Neoplasms, Castration-Resistant/drug therapy , Prostatic Neoplasms, Castration-Resistant/genetics , Prostatic Neoplasms, Castration-Resistant/pathologyABSTRACT
PURPOSE: Targeted biopsy improves prostate cancer diagnosis. Accurate prostate segmentation on magnetic resonance imaging (MRI) is critical for accurate biopsy. Manual gland segmentation is tedious and time-consuming. We sought to develop a deep learning model to rapidly and accurately segment the prostate on MRI and to implement it as part of routine magnetic resonance-ultrasound fusion biopsy in the clinic. MATERIALS AND METHODS: A total of 905 subjects underwent multiparametric MRI at 29 institutions, followed by magnetic resonance-ultrasound fusion biopsy at 1 institution. A urologic oncology expert segmented the prostate on axial T2-weighted MRI scans. We trained a deep learning model, ProGNet, on 805 cases. We retrospectively tested ProGNet on 100 independent internal and 56 external cases. We prospectively implemented ProGNet as part of the fusion biopsy procedure for 11 patients. We compared ProGNet performance to 2 deep learning networks (U-Net and holistically-nested edge detector) and radiology technicians. The Dice similarity coefficient (DSC) was used to measure overlap with expert segmentations. DSCs were compared using paired t-tests. RESULTS: ProGNet (DSC=0.92) outperformed U-Net (DSC=0.85, p <0.0001), holistically-nested edge detector (DSC=0.80, p <0.0001), and radiology technicians (DSC=0.89, p <0.0001) in the retrospective internal test set. In the prospective cohort, ProGNet (DSC=0.93) outperformed radiology technicians (DSC=0.90, p <0.0001). ProGNet took just 35 seconds per case (vs 10 minutes for radiology technicians) to yield a clinically utilizable segmentation file. CONCLUSIONS: This is the first study to employ a deep learning model for prostate gland segmentation for targeted biopsy in routine urological clinical practice, while reporting results and releasing the code online. Prospective and retrospective evaluations revealed increased speed and accuracy.
Subject(s)
Deep Learning , Image Processing, Computer-Assisted/methods , Prostate/diagnostic imaging , Prostatic Neoplasms/diagnosis , Datasets as Topic , Feasibility Studies , Humans , Image-Guided Biopsy/methods , Magnetic Resonance Imaging, Interventional , Male , Multimodal Imaging/methods , Multiparametric Magnetic Resonance Imaging , Proof of Concept Study , Prospective Studies , Prostate/pathology , Prostatic Neoplasms/pathology , Reproducibility of Results , Retrospective Studies , Software , Time Factors , Ultrasonography, Interventional/methodsABSTRACT
OBJECTIVES: To develop and validate the Preoperative Risk Evaluation for Partial Nephrectomy (PREP) score to predict the probability of major postoperative complications after partial nephrectomy (PN) based on patient comorbidities. PATIENTS AND METHODS: The Premier Healthcare Database was used to identify patients who had undergone elective PN. Through review of International Classification of Diseases ninth revision codes, we identified patient comorbidities and major surgical complications (Clavien-Dindo Grade III-V). Multivariable logistic regression was used to identify predictors of major complications. We used half of the set as the training cohort to develop our risk score and the other half as a validation cohort. RESULTS: From 2003 to 2015, 25 451 PNs were performed. The overall rate of major complications was 4.9%. The final risk score consisted of 10 predictors: age, sex, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, hypertension, obesity, and smoking. In the training cohort, the area under the receiver operating characteristic curve (AUC) was 0.75 (95% confidence interval [CI] 0.73-0.78), while the AUC for the validation cohort was 0.73 (95% CI 0.70-0.75). The predicted probabilities of major complication in the low- (≤10 points), intermediate- (11-20 points), high- (21-30 points), and very high-risk (>30 points) categories were 3% (95% CI 2.6-3.2), 8% (95% CI 7.2-9.2), 24% (95% CI 20.5-27.8), and 41% (95% CI 34.5-47.8), respectively. CONCLUSIONS: We developed and validated the PREP score to predict the risk of complications after PN based on patient characteristics. Calculation of the PREP score can help providers select treatment options for patients with a cT1a renal mass and enhance the informed consent process for patients planning to undergo PN.
Subject(s)
Cardiovascular Diseases/epidemiology , Kidney Neoplasms/epidemiology , Kidney Neoplasms/surgery , Nephrectomy/adverse effects , Postoperative Complications/etiology , Age Factors , Aged , Area Under Curve , Calibration , Comorbidity , Databases, Factual , Diabetes Mellitus/epidemiology , Female , Humans , Male , Middle Aged , Nephrectomy/statistics & numerical data , Obesity/epidemiology , Probability , Pulmonary Disease, Chronic Obstructive/epidemiology , ROC Curve , Renal Insufficiency, Chronic/epidemiology , Retrospective Studies , Risk Assessment/methods , Risk Factors , Sex Factors , Smoking/epidemiologyABSTRACT
PURPOSE: To evaluate the diagnostic accuracy of SelectMDx and its association with multiparametric magnetic resonance (mpMRI) in predicting prostate cancer (PCa) and clinically significant PCa (csPCa) on prostate biopsies among men scheduled for initial prostate biopsy. METHODS: In this single-center prospective study, 52 men scheduled for initial prostate biopsy, based on elevated total PSA level (> 3 ng/ml) or abnormal digital rectal examination, were consecutively included. All subjects underwent SelectMDx, PSA determination and mpMRI. RESULTS: SelectMDx score was positive in 94.1 and 100% of PCa and csPCa, respectively, and in only 8.6% of negative cases at biopsy. The probability for a csPCa at the SelectMDx score was significantly (p = 0.002) higher in csPCa (median value 52.0%) than in all PCa (median value 30.0%). SelectMDx showed slightly lower sensitivity (94.1 versus 100.0%) but higher specificity (91.4%) than total PSA (17.1%), and the same sensitivity but higher specificity than mpMRI (80.0%) in predicting PCa at biopsy. The association of SelectMDx plus mpMRI rather than PSA density (PSAD) plus mpMRI showed higher specificity (both 91.4%) compared to the association of PSA plus mpMRI (85.7%). In terms of csPCa predictive value, SelectMDx showed higher specificity (73.3%) than PSA (13.3%) and mpMRI (64.4%); as for the association of SelectMDx plus mpMRI (75.6%) versus PSA plus mpMRI (68.9%), the association of PSAD plus mpMRI showed the highest specificity (80.0%). CONCLUSION: Our results of SelectMDx can be confirmed as significant but their impact on clinical practice together with a cost-effectiveness evaluation should be investigated in a larger prospective multicenter analysis.
Subject(s)
Biomarkers, Tumor/urine , Cell Cycle Proteins/genetics , Homeodomain Proteins/genetics , Multiparametric Magnetic Resonance Imaging , Prostate/pathology , Prostatic Neoplasms/genetics , Prostatic Neoplasms/urine , Transcription Factors/genetics , Adult , Aged , Humans , Image-Guided Biopsy , Male , Middle Aged , Prospective Studies , Prostatic Neoplasms/pathology , Reproducibility of ResultsABSTRACT
PURPOSE: The association between circulating total testosterone (T) levels and clinically significant PCa is still a matter of debate. In this study, we evaluated whether serum testosterone levels may have a role in predicting unfavorable disease (UD) and biochemical recurrence (BCR) in patients with clinically localized (≤ cT2c) ISUP grade group 1 PCa at biopsy. METHODS: 408 patients with ISUP grade group 1 prostate cancer, undergone to radical prostatectomy and T measurement were included. The outcome of interest was the presence of unfavourable disease (UD) defined as ISUP grade group [Formula: see text] 3 and/or pT [Formula: see text] 3a. RESULTS: Statistically significant differences resulted between serum testosterone values and ISUP grade groups (P < 0.0001). Significant correlation was found analyzing testosterone values versus age (P < 0.0001), and versus PSA (P = 0.008). BCR-free survival was significantly decreased in patients with low levels of testosterone (P = 0.005). These findings were confirmed also in the ISUP 1-2 subgroups (P = 0.01). ROC curve analysis showed that T outperformed PSA in predicting UD (AUC 0.718 vs AUC 0.525; P < 0.001) and was and independent risk factor for BCR. CONCLUSION: Our findings suggested that circulating total T was a significant predictor of UD at RP in patients with preoperative low- to intermediate-risk diseases, confirming the potential role of circulating androgens in preoperative risk assessment of PCa patients.
Subject(s)
Prostatectomy , Prostatic Neoplasms/blood , Prostatic Neoplasms/surgery , Testosterone/blood , Aged , Biopsy , Humans , Male , Middle Aged , Neoplasm Grading , Neoplasm Recurrence, Local/blood , Neoplasm Recurrence, Local/epidemiology , Preoperative Period , Prognosis , Prostatectomy/methods , Prostatic Neoplasms/pathologyABSTRACT
PURPOSE: Urinary incontinence (UI) after radical prostatectomy (RP) is an early side effect after catheter removal. This systematic review and meta-analysis were conducted to compare different forms of non-invasive treatments for post-RP UI and to analyse whether the addition of biofeedback (BF) and/or pelvic floor muscle electric stimulation (PFES) to PF muscle exercise (PFME) alone can improve results in terms of continence recovery rate. MATERIALS AND METHODS: A literature search was performed following the PRISMA guidelines. We performed a cumulative meta-analysis to explore the trend in the effect sizes across subgroups during a 12-months follow-up. RESULTS: Twenty-six articles were selected. At baseline after RP and catheter removal, mean pad weight varied extremely. At 1- and 3-months intervals, mean difference in pad weight recovery from baseline was significantly higher using guided programs (BF, PFES or both) than using PFME alone (3-months: PFME 111.09 g (95%CI 77.59-144.59), BF 213.81 g (95%CI -80.51-508-13), PFES 306.88 g (95%CI 158.11-455.66), BF + PFES 266.31 g (95%CI 22.69-302.93); P < .01), while at 6- and 12-months differences were similar (P > .04). At 1- and 3-months intervals, event rate (ER) of continence recovery was significantly higher using guided programs than using PFME alone (3-months: PFME 0.40 (95%CI 0.30-0.49), BF 0.49 (95%CI 0.31-0.67), PFES 0.57 (95%CI 0.46-0.69), BF + PFES 0.75 (95%CI 0.60-0.91); P < .01), while at 6- and 12-months ERs were similar. CONCLUSIONS: Regarding non-invasive treatment of UI secondary to RP, the addition of guided programs using BF or/and PFES demonstrated to improve continence recovery rate, particularly in the first 3-month interval, when compared with the use of PFME alone.
Subject(s)
Exercise Therapy , Pelvic Floor , Biofeedback, Psychology , Electric Stimulation , Humans , Male , Prostatectomy/adverse effects , Treatment OutcomeABSTRACT
PURPOSE: Hispanic men in the USA experience the second-highest incidence rate of testicular germ cell tumors (TGCTs), behind non-Hispanic (NH) White men, and have experienced steep increases in TGCT in recent decades. It is unknown whether increases in incidence differ according to neighborhood sociodemographic factors. METHODS: We conducted a population-based study of n = 3759 Hispanic and n = 8469 NH White men (n = 12,228 total) diagnosed with TGCT in California during the three most recent pericensal periods. We calculated incidence rates according to neighborhood socioeconomic status (nSES) and among Hispanics, according to ethnic enclave. We calculated incidence rate ratios to compare rates across nSES and ethnic enclave and to examine changes in rates over pericensal time periods according to these neighborhood factors for major histologic types (i.e., seminoma and nonseminoma). RESULTS: Hispanic men residing in high SES, compared to low SES, neighborhoods had greater incidence of seminoma and nonseminoma testicular cancer across pericensal periods, as did Hispanic men in low enclave (less ethnic), compared to high enclave, neighborhoods. Between the periods 1998-2002 and 2008-2012, Hispanic men residing in low SES neighborhoods experienced a 39% increased incidence of seminoma, while those residing in low and middle SES neighborhoods experienced 87% and 48% increased incidence of nonseminoma, respectively. CONCLUSION: While TGCT incidence has increased among all Hispanic men, incidence increases appear to be driven disproportionately by those residing in lower SES and lower enclave neighborhoods, particularly for nonseminoma.
Subject(s)
Hispanic or Latino , Neoplasms, Germ Cell and Embryonal/ethnology , Seminoma/ethnology , Testicular Neoplasms/ethnology , Adolescent , Adult , California/epidemiology , Humans , Incidence , Male , Middle Aged , Neoplasms, Germ Cell and Embryonal/epidemiology , Residence Characteristics , Seminoma/epidemiology , Social Class , Testicular Neoplasms/epidemiology , Young AdultABSTRACT
OBJECTIVES: (I) To determine Vesical Imaging-Reporting and Data System (VI-RADS) score 5 accuracy in predicting locally advanced bladder cancer (BCa), so as to potentially identify those patients who could avoid the morbidity of deep transurethral resection of bladder tumour (TURBT) in favour of histological sampling-TUR prior to radical cystectomy (RC). (II) To explore the predictive value of VI-RADS score 5 on time-to-cystectomy (TTC) outcomes. PATIENTS AND METHODS: We retrospectively reviewed patients' ineligible or refusing cisplatin-based combination neoadjuvant chemotherapy who underwent multiparametric magnetic resonance imaging (mpMRI) of the bladder prior to staging TURBT followed by RC for muscle-invasive BCa. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) were calculated for VI-RADS score 5 vs. score 2-4 cases to assess the accuracy of mpMRI for extravesical BCa detection (≥pT3). VI-RADS score performance was assessed by receiver operating characteristics curve analysis. A Κ statistic was calculated to estimate mpMRI and pathological diagnostic agreement. The risk of delayed TTC (i.e. time from initial BCa diagnosis of >3 months) was assessed using multivariable logistic regression model. RESULTS: A total of 149 T2-T4a, cN0-M0 patients (VI-RADS score 5, n = 39 vs VI-RADS score 2-4, n = 110) were examined. VI-RADS score 5 demonstrated sensitivity, specificity, PPV and NPV, in detecting extravesical disease of 90.2% (95% confidence interval [CI] 84-94.3), 98.1% (95% CI 94-99.6), 94.9% (95% CI 89.6-97.6) and 96.4% (95% CI 91.6-98.6), respectively. The area under the curve was 94.2% (95% CI 88.7-99.7) and inter-reader agreement was excellent (Κinter 0.89). The mean (SD) TTC was 4.2 (2.3) and 2.8 (1.1) months for score 5 vs 2-4, respectively (P < 0.001). VI-RADS score 5 was found to independently increase risk of delayed TTC (odds ratio 2.81, 95% CI 1.20-6.62). CONCLUSION: The VI-RADS is valid and reliable in differentiating patients with extravesical disease from those with muscle-confined BCa before TURBT. Detection of VI-RADS score 5 was found to predict significant delay in TTC independently from other clinicopathological features. In the future, higher VI-RADS scores could potentially avoid the morbidity of extensive primary resections in favour of sampling-TUR for histology. Further prospective, larger, and multi-institutional trials are required to validate clinical applicability of our findings.
Subject(s)
Cystectomy/methods , Time-to-Treatment/statistics & numerical data , Urinary Bladder Neoplasms , Aged , Cystoscopy , Female , Humans , Male , Middle Aged , Multiparametric Magnetic Resonance Imaging , Neoplasm Staging , Predictive Value of Tests , Preoperative Care , Retrospective Studies , Urinary Bladder/diagnostic imaging , Urinary Bladder/pathology , Urinary Bladder/surgery , Urinary Bladder Neoplasms/diagnostic imaging , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgeryABSTRACT
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation. This randomised, double-blind, placebo-controlled trial investigated the effect of 6-month supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes. In 94 patients who completed the study, all sperm parameters increased in supplemented patients compared to the placebo group. A significant (p = .0272) difference in supplementation efficacy was observed for total motility on patients with varicocele and BMI < 25. In the same group, also the progressive motility was significantly superior (p = .0159). For Responder analysis, total motility results were confirmed in both the cited group (p = .0066) and in the varicocele group with BMI < 25 and age < 35 (p = .0078). This study suggests that supplementation is more effective in subjects with varicocele younger than 35 years with BMI < 25.
Subject(s)
Antioxidants/administration & dosage , Body Mass Index , Dietary Supplements , Infertility, Male/diet therapy , Micronutrients/administration & dosage , Varicocele/diet therapy , Adolescent , Adult , Age Factors , Double-Blind Method , Humans , Infertility, Male/etiology , Infertility, Male/pathology , Male , Middle Aged , Oxidative Stress/drug effects , Placebos/administration & dosage , Reactive Oxygen Species/metabolism , Sperm Count , Sperm Motility/drug effects , Sperm Motility/physiology , Treatment Outcome , Varicocele/complications , Varicocele/pathology , Young AdultABSTRACT
OBJECTIVE: To examine the incidence of perioperative complications after radical cystectomy (RC) and assess their impact on 90-day postoperative mortality during the index stay and upon readmission. PATIENTS AND METHODS: A total of 57 553 patients with bladder cancer (unweighted cohort: 9137 patients) treated with RC, at 360 hospitals in the USA between 2005 and 2013 within the Premier Healthcare Database, were used for analysis. The 90-day perioperative mortality was the primary outcome. Multivariable regression was used to predict the probability of mortality; models were adjusted for patient, hospital, and surgical characteristics. RESULTS: An increase in the number of complications resulted in an increasing predicted probability of mortality, with a precipitous increase if patients had four or more complications compared to one complication during hospitalisation following RC (index stay; 1.0-9.7%, P < 0.001) and during readmission (2.0-13.1%, P < 0.001). A readmission complication nearly doubled the predicted probability of postoperative mortality as compared to an initial complication (3.9% vs 7.4%, P < 0.001). During the initial hospitalisation cardiac- (odds ratio [OR] 3.1, 95% confidence interval [CI] 1.9-5.1), pulmonary- (OR 4.8, 95% CI 2.8-8.4), and renal-related (OR 3.6, 95% CI 2-6.7) complications had the most significant impact on the odds of mortality across categories examined. CONCLUSIONS: The number and nature of complications have a distinct impact on mortality after RC. As complications increase there is an associated increase in perioperative mortality.
Subject(s)
Cystectomy/adverse effects , Postoperative Complications/epidemiology , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/surgery , Aged , Databases, Factual , Female , Hospital Mortality , Hospitalization , Humans , Incidence , Male , Middle Aged , Operative Time , Retrospective Studies , Risk Factors , Survival RateABSTRACT
PURPOSE: This study aims to analyze patient demographics, hospital characteristics, and clinical risk factors which predict penile prosthesis removal. We also examine costs of penile prosthesis removal and trends in inflatable versus non-inflatable penile prostheses implantation in the USA from 2003 to 2015. METHODS: Cross-sectional analysis from Premier Perspective Database was completed using data from 2003 to 2015. We compared the relative proportion of inflatable versus non-inflatable penile prostheses implanted. We separated the prosthesis removal group based on indication for removal-Group 1 (infection), Group 2 (mechanical complication), and Group 3 (all explants). All groups were compared to a control group of patients with penile implants who were never subsequently explanted. Multivariate analysis was performed to analyze patient and hospital factors which predicted removal. Cost comparison was performed between the explant groups. RESULTS: There were 5085 penile prostheses implanted with a stable relative proportion of inflatable versus non-inflatable prosthesis over the 13-year study period. There were 3317 explantations. Patient factors associated with prosthesis removal were non-black race, Charlson Comorbidity Index, diabetes, and HIV status. Hospital factors associated with removal included non-teaching status, hospital region, year of removal, and annual surgeon volume. Median hospitalization costs of all explantations were $10,878. Explantations due to infection cost $11,252 versus $8602 for mechanical complications. CONCLUSIONS: This large population-based study demonstrates a stable trend in inflatable versus non-inflatable prosthesis implantation. We also identify patient and hospital factors that predict penile prosthesis removal which has clinical utility for patient risk stratification and counseling.