Avoiding Prostate Biopsies in Patients at Low Risk for Prostate Cancer: A Prospective Evaluation of a PSA-Density-Based Safety Net.

INTRODUCTION AND OBJECTIVES: Decision-making to perform prostate biopsy should include individual risk assessment. Patients classified as low risk by the Rotterdam Prostate Cancer Risk Calculator are advised to forego biopsy (PBx). There is concern about missing clinically significant prostate cancer (csPCa). A clear pathway for follow-up is needed. MATERIAL AND METHODS: Data for 111 consecutive patients were collected. Patients were encouraged to adhere to a PSA-density-based safety net after PBx was omitted. Cut off values indicating a re-evaluation were PSA density >0.15 ng/mL/ccm in PBx-naïve patients and >0.2 ng/mL/ccm in men with past-PBx. Primary endpoint was whether men had their PSA taken regularly. Secondary endpoint was whether a new multiparametric MRI was performed when PSA-density increased. Tertiary endpoint was whether biopsy was performed when risk stratification revealed an increased risk. RESULTS: Median follow-up was 12 months (IQR 9-15 months). The primary endpoint was reached by 97.2% (n = 106). The secondary endpoint was reached by 30% (n = 3). The tertiary endpoint was reached by 50% (n = 2). Histopathologic analyses revealed csPCa in none of these cases. Risk stratification did not change (p = 0.187) with the majority of patients (89.2%, n = 99). CONCLUSION: The concern of missing csPCa when omitting PBx in the risk-stratified pathway may be negated. Changes in risk stratification during follow-up should lead to subsequent PBx. We suggest implementing a safety net based on PSA density and digital rectal examination (DRE).

Comparison of prostate cancer detection rates in patients undergoing MRI/TRUS fusion prostate biopsy with two different software-based systems.

BACKGROUND: Magnetic resonance imaging (MRI)-targeted prostate biopsy is a routinely used diagnostic tool for prostate cancer (PCa) detection. However, a clear superiority of the optimal approach for software-based MRI processing during biopsy procedures is still unanswered. To investigate the impact of robotic approach and software-based image processing (rigid vs. elastic) during MRI/transrectal ultrasound (TRUS) fusion prostate biopsy (FBx) on overall and clinically significant (cs) PCa detection. METHODS: The study relied on the instructional retrospective biopsy data collected data between September 2013 and August 2017. Overall, 241 men with at least one suspicious lesion (PI-RADS ≥ 3) on multiparametric MRI underwent FBx. The study protocol contains a systematic 12-core sextant biopsy plus 2 cores per targeted lesion. One experienced urologist performed 1048 targeted biopsy cores; 467 (45%) cores were obtained using rigid processing, while the remaining 581 (55%) cores relied on elastic image processing. CsPCa was defined as International Society of Urological Pathology (ISUP) grade ≥ 2. The effect of rigid versus elastic FBx on overall and csPCa detection rates was determined. Propensity score weighting and multivariable regression models were used to account for potential biases inherent to the retrospective study design. RESULTS: In multivariable regression analyses, age, prostate-specific antigen (PSA), and PIRADS ≥ 3 lesion were related to higher odds of finding csPCa. Elastic software-based image processing was independently associated with a higher overall PCa (odds ratio [OR] = 3.6 [2.2-6.1], p < 0.001) and csPCa (OR = 4.8 [2.6-8.8], p < 0.001) detection, respectively. CONCLUSIONS: Contrary to existing literature, our results suggest that the robotic-driven software registration with elastic fusion might have a substantial effect on PCa detection.

Psychosocial Distress in the Early Recovery Period after Radical Prostatectomy.

PURPOSE: This study aimed to evaluate psychosocial distress in the context of continence and oncological outcome during the early recovery period after radical prostatectomy (RP) for prostate cancer. PATIENTS AND METHODS: Retrospectively collected data from 587 patients who underwent inpatient rehabilitation after RP in 2016 and 2017 were analyzed. Psychosocial distress (measured by using a Questionnaire on Stress in Cancer Patients [QSC-R10]) and continence status (urine loss on a 24-h pad test and urine volume on uroflowmetry) were evaluated at the beginning (T1) and end (T2) of a 3-week inpatient rehabilitation. Multivariate logistic regression was performed to identify predictors for high distress (QSC-R10 score ≥15). RESULTS: The median patient age was 65 years. At the start of rehabilitation, 204 patients (34.8%) demonstrated high distress. Psychosocial distress decreased significantly (p < 0.001) from a median of 11.0 at T1 (median 16 days after surgery) to a median of 6.0 at T2 (median 37 days after surgery). Complete continence increased significantly (p < 0.001) from 39.0% at T1 to 58.9% at T2. The median urine volume increased significantly (p < 0.001) from 161 mL at T1 to 230 mL at T2. Often, distress is higher in younger patients, whereas incontinence is higher in older patients. Multivariate logistic regression analysis identified age ≤69 years (p = 0.001) and tumor stage ≥pT3 (p = 0.006) as independent predictors of high distress. CONCLUSIONS: Distress and incontinence decreased significantly during the 3 weeks of inpatient rehabilitation after RP. Patient age ≤69 years and tumor stage ≥pT3 are independent predictors of high psychosocial distress.

How Many Cores Should Be Sampled during Systematic Prostate Biopsy in Case of Negative Multiparametric Magnetic Resonance Imaging? Analysis of 274 Men with Clinical Suspicion of Prostate Cancer.

INTRODUCTION: This study aimed to investigate the number of cores needed in a systematic biopsy (SB) in men with clinical suspicion of prostate cancer (PCa) but negative prebiopsy multiparametric magnetic resonance imaging and to test prostate-specific antigen (PSA) density as an indicator for reduced SB. METHODS: Two hundred and seventy-four patients were analyzed, extracted from an institutional database. Detection rates of any PCa and clinically significant (CS) PCa for different reduced biopsy protocols were compared by using Fisher's exact test. RESULTS: In total, 12-core SB revealed PCa in 103 (37.6%) men. Detection rates of reduced biopsy protocols were 74 (27%, 6-core) and 82 (29.9%, 8-core). Regarding CSPCa, 12-core SB revealed a detection rate of 26 (9.5%). Reduced biopsy protocols detected less CSPCa: 15 (5.5%) and 18 (6.6%), respectively. All differences were statistically significant, p < 0.05. PSA density ≥0.15 did not help to filter out men in whom a reduced biopsy may be sufficient. CONCLUSIONS: Twelve-core SB still has the highest detection rate of any PCa and CSPCa compared to reduced biopsy protocols. If the investigator and patient agree - based on individual risk calculation - to perform a biopsy, this SB should contain at least 12 cores regardless of PSA density.

Identification of patients at risk for biochemical recurrence after radical prostatectomy with intra-operative frozen section.

OBJECTIVE: To identify patients at risk for biochemical recurrence (BCR) of prostate cancer (PCa) after radical prostatectomy (RP) with intra-operative whole-mount frozen section (FS) of the prostate. MATERIAL AND METHODS: We examined differences in BCR between patients with initial negative surgical margins at FS, patients with final negative surgical margins with initial positive margins at FS without residual PCa after secondary tumour resection, and patients with final negative surgical margins with initially positive margins at FS with residual PCa in the secondary tumour resection specimen. Institutional data of 883 consecutive patients undergoing RP were collected. Intra-operative whole-mount FS was routinely used to check for margin status and, if necessary, to resect more periprostatic tissue in order to achieve negative margins. Patients with lymph node-positive disease or final positive surgical margins were excluded from the analysis. Kaplan-Meier curves and multivariable Cox proportional hazards regression analyses adjusting for clinical covariates were employed to examine differences in biochemical recurrence-free survival (BRFS) according to the resection status mentioned above. RESULTS: The median follow-up was 22.4 months. The 1- and 2-year BRFS rates in patients with (81.0% and 72.9%, respectively; P = 0.001) and without residual PCa (90.3% and 82.3%, respectively; P = 0.033) after secondary tumour resection were significantly lower compared to patients with initial R0 status (93.4% and 90.9%, respectively). On multivariable Cox regression only residual PCa in the secondary tumour resection was associated with a higher risk of BCR compared to initial R0 status (hazard ratio 1.99, 95% confidence interval 1.01-3.92; P = 0.046). CONCLUSION: Despite being classified as having a negative surgical margin, patients with residual PCa in the secondary tumour resection specimen face a high risk of BCR. These findings warrant closer post-RP surveillance of this particular subgroup. Further research of this high-risk subset of patients should focus on examining whether these patients benefit from early salvage therapy and how resection status impacts oncological outcomes in the changing landscape of PCa treatment.

Probability of Prostate Cancer Diagnosis following Negative Systematic and Targeted MRI: Transrectal Ultrasound Fusion Biopsy: A Real-Life Observational Study.

INTRODUCTION: The risk of occult prostate carcinoma (PCa) after negative multiparametric MRI (mpMRI)-transrectal fusion biopsy (F-Bx) is unknown. To determine the false-negative predictive value, we examined PCa detection after prior negative F-Bx. METHODS: Between December 2012 and November 2016, 491 patients with suspected PCa and suspicious mpMRI findings underwent transrectal F-Bx. Patients with benign pathology (n = 191) were eligible for our follow-up (FU) survey. Patient characteristics and clinical parameters were correlated to subsequent findings of newly detected PCa. RESULTS: Complete FU with a median of 31 (interquartile range: 17-39) months was available for 176/191 (92.2%) patients. Of those, 54 men had either surgical interventions on the prostate or re-Bxs. Newly detected PCa was evident in 14/176 (7.95%) patients stratified to ISUP ≤2 in 10 and ≥3 in 4 cases. The comparison of patients with newly detected PCa to those without cancerous findings in FU showed significant differences in prostate-specific antigen (PSA) density (0.16 vs. 0.13 ng/mL2) and prostate volume (45 vs. 67 mL, both p < 0.05). Both factors are significant predictors for newly detected cancer after initial negative F-Bx. CONCLUSION: Only PSA density (>0.13 ng/mL2) and small prostate volume are significant predictors for newly detected PCa after initial negative F-Bx. Despite negative mpMRI/TRUS F-Bx results, patients should be further monitored due to a risk of developing PCa over time. Notwithstanding the limitation of our study that not all patients underwent another Bx, we assume that the false-negative rate is low but existing. Our data represent a real-world scenario.

Association between Development of Metabolic Acidosis and Improvement of Urinary Continence after Ileal Neobladder Creation.

PURPOSE: Ileal neobladder construction is a common choice for orthotopic urinary diversion following radical cystectomy. We investigated risk factors for metabolic acidosis during the early recovery period. MATERIALS AND METHODS: This study relied on retrospectively collected data on 345 patients who underwent inpatient rehabilitation after radical cystectomy and ileal neobladder construction for bladder cancer between January 2014 and March 2017. Acid-base status, use of sodium bicarbonate to correct metabolic acidosis and continence status were evaluated at the beginning and end of 3 weeks of inpatient rehabilitation. Multivariate logistic regression analysis was performed to identify risk factors associated with the development of metabolic acidosis. RESULTS: At the start of rehabilitation a median of 29 days after surgery (IQR 23-37) 200 patients (58.0%) had metabolic acidosis. During the inpatient rehabilitation period the need for oral sodium bicarbonate replacement due to acidosis increased significantly from 45.2% to 86.7% of patients (p <0.001) while urine loss measured by a 24-hour pad test decreased significantly from a median of 387 (IQR 98-918) to 88 gm (IQR 5-388, p <0.001). The median base excess was within the normal range (-1.2 mmol/l, IQR -2.4 - 0.0) at the end of inpatient rehabilitation. Decreased urinary leakage was identified as an independent risk factor for metabolic acidosis.Conclusions:The risk of metabolic acidosis after neobladder construction correlated with continuously improved continence in the early recovery period. Therefore, during this period the acid-base status should be assessed more frequently to identify metabolic acidosis.

Institutional Adoption and Apprenticeship of Fusion Targeted Prostate Biopsy: Does Experience Affect the Cancer Detection Rate?

INTRODUCTION: There are limited data on the learning curve of magnetic resonance imaging/transrectal ultrasound (MRI/TRUS)-fusion targeted prostate biopsies (tBx). OBJECTIVE: The aim of this study was to investigate the difference in prostate cancer (PCa) detection rate between an experienced urologist and novice resident performing tBx. METHODS: A total of 183 patients underwent tBx from 2012 to 2016 for a total of 518 tBx cores. Biopsies in this study were performed by an experienced urologist (investigator A) or a novice resident (investigator B). The outcome was the detection of PCa on tBx. Using a multivariable logistic regression model, we estimated odds ratios for the detection of PCa. Inverse probability treatment weighting (IPTW) was used to balance patients' baseline characteristics and compare detection rates of PCa. Before performance of tBx, all patients underwent MRI. RESULTS: On multivariable logistic regression analysis, investigator experience was associated with a higher odds of detection of PCa (OR = 1.003; 95% confidence interval 1.002-1.006, p = 0.037). After IPTW adjustment, there was no significant difference between the detection rate of investigator A (23%) and investigator B (32%; p = 0.457). CONCLUSIONS: Data revealed a positive association between investigator experience and the odds of PCa detection, although there was no difference in the detection rates of the investigators.

Impact of testosterone replacement therapy on thromboembolism, heart disease and obstructive sleep apnoea in men.

OBJECTIVES: To assess the association of testosterone replacement therapy (TRT) with thromboembolism, cardiovascular disease (stroke, coronary artery disease and heart failure) and obstructive sleep apnoea (OSA). METHODS: A cohort of 3 422 male US military service members, retirees and their dependents, aged 40-64 years, was identified, who were prescribed TRT between 2006 and 2010 for low testosterone levels. The men in this cohort were matched on a 1:1 basis for age and comorbidities to men without a prescription for TRT. Event-free survival and rates of thromboembolism, cardiovascular events and OSA were compared between men using TRT and the control group, with a median follow-up of 17 months. RESULTS: There was no difference in event-free survival with regard to thromboembolism (P = 0.239). Relative to controls, men using TRT had improved cardiovascular event-free survival (P = 0.004), mainly as a result of lower incidence of coronary artery disease (P = 0.008). The risk of OSA was higher in TRT users (2-year risk 16.5% [95% confidence interval 15.1-18.1] in the TRT group vs 12.7% [11.4-14.1] in the control group. CONCLUSIONS: This study adds to growing evidence that the cardiovascular risk associated with TRT may be lower than once feared. The elevated risk of OSA in men using TRT is noteworthy.

De novo neurogenic bladder dysfunction after salvage lymph node dissection in patients with nodal recurrence of prostate cancer.

AIMS: To examine the impact of Salvage lymph node dissection (SLND) on bladder function and oncological outcome in hormone naïve patients with nodal recurrence of prostate cancer (PCa) after radical prostatectomy (RP). METHODS: In a prospective study between October 2015 and November 2016, 20 patients underwent transperitoneal SLND for nodal recurrence of PCa after RP at our institution. Standardized urodynamics were performed pre- and postoperatively after 6 weeks, 3, and 6 to 12 months. Prostate-specific antigen (PSA) levels were used to monitor the oncological outcome. Perioperative outcomes encompassed, among others, type of complications after surgery classified to Clavien-Dindo. RESULTS: The proportion of patients with neurogenic bladder dysfunction was postoperative at 6 weeks, 3, and 6 to 12 months 78.5%, 70%, and 45.5%, respectively. Compared to preoperative urodynamics, follow-ups revealed a statistical significant cleavage of bladder wall compliance until six to twelve months after SLND (34.5 vs 22 mL/cmH2 O, P = 0.044). Referring to the oncological outcome all patients experienced a PSA progression, 10 patients (50%) within 11 weeks after surgery. Overall, four patients (20%) suffered from a postoperative complication after SLND, which comprises Clavien grade I-IIIa. CONCLUSIONS: Transperitoneal SLND, as a treatment option for patients with nodal recurrence of PCa after RP reveals additional potential pitfalls than previously reported. Urodynamics reveal a significant impact of SLND on postoperative functional bladder dysfunctions. Therefore, informed consent prior to SLND should include the risk of persistent low compliance bladder.

Determinants of cancer screening in Asian-Americans.

PURPOSE: Recent data suggest that Asian-Americans (AsAs) are more likely to present with advanced disease when diagnosed with cancer. We sought to determine whether AsAs are under-utilizing recommended cancer screening. METHODS: Cross-sectional analysis of the 2012 Behavioral Risk Factor Surveillance System comprising of AsAs and non-Hispanic White (NHW) community-dwelling individuals (English and Spanish speaking) eligible for colorectal, breast, cervical, or prostate cancer screening according to the United States Preventive Services Task Force recommendations. Age, education and income level, residence location, marital status, health insurance, regular access to healthcare provider, and screening were extracted. Complex samples logistic regression models quantified the effect of race on odds of undergoing appropriate screening. Data were analyzed in 2015. RESULTS: Weighted samples of 63.3, 33.3, 47.9, and 30.3 million individuals eligible for colorectal, breast, cervical, and prostate cancer screening identified, respectively. In general, AsAs were more educated, more often married, had higher levels of income, and lived in urban/suburban residencies as compared to NHWs (all p < 0.05). In multivariable analyses, AsAs had lower odds of undergoing colorectal (odds ratio [OR] 0.78, 95 % confidence interval [CI] 0.63-0.96), cervical (OR 0.45, 95 % CI 0.36-0.55), and prostate cancer (OR 0.55, 95 % CI 0.39-0.78) screening and similar odds of undergoing breast cancer (OR 1.29, 95 % CI 0.92-1.82) screening as compared to NHWs. CONCLUSIONS: AsAs are less likely to undergo appropriate screening for colorectal, cervical, and prostate cancer. Contributing reasons include limitations in healthcare access, differing cultural beliefs on cancer screening and treatment, and potential physician biases. Interventions such as increasing healthcare access and literacy may improve screening rates.

Wound dehiscence in a sample of 1 776 cystectomies: identification of predictors and implications for outcomes.

OBJECTIVE: To investigate the incidence and predictors of wound dehiscence in patients undergoing radical cystectomy (RC). PATIENTS AND METHODS: In all, 1 776 patient records with Current Procedural Terminology (CPT) codes for radical cystectomy (RC) were extracted from the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) between 2005 and 2012. Stratification was made based on the occurrence of postoperative wound dehiscence, defined as loss of integrity of fascial closure. Descriptive and logistic regression models were used to identify predictors of postoperative wound dehiscence. The implications of wound dehiscence on peri- and postoperative outcomes such as complications, mortality, prolonged length of stay (>11 days), and prolonged operative time (>411 min), were assessed. RESULTS: Of 1 776 patients analysed, 57 (3.2%) had a documented wound dehiscence. In multivariable analyses, chronic obstructive pulmonary disease (odds ratio [OR] 2.0, 95% confidence interval [CI] 1.0-4.0; P = 0.03) and high body mass index (OR 2.3, 95% CI 1.3-4.4; P = 0.008) were significant predictors of wound dehiscence. While female gender had significantly lower proportions of wound dehiscence, multivariable analyses did not confirm this (OR 0.4, 95% CI 0.4-1.4; P = 0.75). CONCLUSIONS: Our study is the first to identify predictors of wound dehiscence after RC in a large, contemporary multi-institutional cohort. Identifying patients at risk of postoperative wound complications may guide the use of preventative measures at the time of surgery.

The influence of marital status on the use of breast, cervical, and colorectal cancer screening.

PURPOSE: To examine the impact of marital status on the use of screening for breast, cervical, and colorectal cancer. METHODS: We relied on 2012 Behavioral Risk Factor Surveillance System Survey age-appropriate screening cohorts. Appropriate screening for breast, cervical, and colorectal cancer was determined according to United States Preventive Services Task Force recommendations in effect at the time of the 2012 survey. Complex samples logistic regression models were performed to examine the effect of marital status on cancer screening. RESULTS: Overall, 81.6, 83.9, and 68.9% of married participants underwent breast, cervical, and colorectal cancer, respectively, relative to 74.2, 75.1, and 60.9% for divorced/widowed/separated, individuals, and 74.7, 78.7, and 53.4% for never married individuals. Marital status (married vs. never married) was an independent predictor of screening for all cancers examined: breast cancer, odds ratio (OR): 1.42 (95% confidence interval [CI]: 1.25-1.61); cervical cancer, OR: 1.29 (95% CI: 1.16-1.43); colorectal cancer, OR: 1.63 (95% CI: 1.51-1.77). Gender-specific subgroup analyses for colorectal cancer suggests that marital status may exert a greater effect in men, relative to women (married men: OR 1.75, 95% CI: 1.56-1.96; married women: OR: 1.52, 95% CI: 1.35-1.70). CONCLUSION: Being married is associated with increased utilization of breast, cervical, and colorectal cancer screening. The influence of marital status was greater in men relative to women eligible for colorectal cancer screening. Our results emphasize the importance of social determinants of health-seeking behaviors.

The impact of Medicare eligibility on cancer screening behaviors.

INTRODUCTION: Lack of health insurance limits access to preventive services, including cancer screening. We examined the effects of Medicare eligibility on the appropriate use of cancer screening services in the United States. METHODS: We performed a cross-sectional analysis of the 2012 Behavioral Risk Factor and Surveillance System (analyzed in 2014). Univariable and logistic regression analyses were performed for participants aged 60-64 and 66-70 to examine the effects of Medicare eligibility on prevalence of self-reported screening for colorectal, breast, and prostate cancers. Sub-analyses were performed among low-income (<$25,000 annual/household) individuals. RESULTS: Medicare-eligible individuals were significantly more likely to undergo all examined preventive services (colorectal cancer OR: 1.90; 95% CI 1.79-2.04; prostate cancer OR: 1.29; 95% CI 1.17-1.43; breast cancer OR: 1.23; 95% CI 1.10-1.37) and the effect was most pronounced among low-income individuals (colorectal cancer OR: 2.04; 95% CI 1.8-2.32; prostate cancer OR: 1.39; 95% CI 1.12-1.72; breast cancer OR: 1.42, 95% CI 1.20-1.67). Access to a healthcare provider was the strongest independent predictor of undergoing appropriate screening, ranging from OR 2.73 (95% CI 2.20-3.39) for colorectal cancer screening in the low-income population to OR 4.79 (95% CI 3.95-5.81) for breast cancer screening in the overall cohort. The difference in screening prevalence was most pronounced when comparing Medicare-eligible participants to uninsured Medicare-ineligible participants (+33.2%). CONCLUSIONS: Medicare eligibility impacts the prevalence of cancer screening, likely as a result of increased access to primary care. Low-income individuals benefit most from Medicare eligibility. Expanded public insurance coverage to these individuals may improve access to preventive services.

Relationship between androgen deprivation therapy and community-acquired respiratory infections in patients with prostate cancer.

OBJECTIVES: To investigate the dose-dependent effect of androgen deprivation therapy on community-acquired respiratory infections in patients with localized prostate cancer. METHODS: We identified 52 905 men diagnosed with localized prostate cancer within the Surveillance, Epidemiology and End Results-Medicare database between 1991 and 2006. We compared those who did not receive androgen deprivation therapy with those who received androgen deprivation therapy within 2 years of diagnosis, calculated as monthly equivalent doses (<7, 7-11, >11 doses), or orchiectomy. Adjusted Cox hazard models were fitted to predict the risk of community-acquired respiratory infections (acute sinusitis, acute bronchitis, [severe] pneumonia) in patients treated with medical androgen deprivation therapy versus orchiectomy versus none. RESULTS: Overall, 43.4% received medical androgen deprivation therapy. These patients more likely experienced respiratory events compared with those who did not receive androgen deprivation therapy or who underwent orchiectomy (62.2% vs 54.5% vs 47.8%, P < 0.001). The risk of experiencing any respiratory event increased with the number of doses received. For example, men receiving >11 doses of androgen deprivation therapy were at greatest risk of acute sinusitis, acute bronchitis and pneumonia (HR 1.13, 1.26 and 1.15, respectively, all P < 0.001), except severe pneumonia. Furthermore, we did not detect any relationship between orchiectomy and respiratory events. Study limitations include the utilization of a retrospective population-based dataset. CONCLUSIONS: Increased exposure to medical androgen deprivation therapy for men with localized prostate cancer is associated with a higher risk of community-acquired respiratory infections. Our results suggest that respiratory complications represent potentially underreported complications of medical androgen deprivation therapy.

Comparison of 30-day perioperative outcomes in adults undergoing open versus minimally invasive pyeloplasty for ureteropelvic junction obstruction: analysis of 593 patients in a prospective national database.

PURPOSE: The surgical correction of ureteropelvic junction obstruction (UPJO) is indicated to prevent progression to chronic renal insufficiency. Minimally invasive surgery (MIS) has become increasingly popular as an approach to UPJO correction. We compared the perioperative outcomes between minimally invasive (MIP) and open pyeloplasty (OP) in the adult population. METHODS: The current study was performed using the American College of Surgeons National Surgical Quality Improvement Program. Patients were identified using Current Procedural Terminology codes for pyeloplasty between 2005 and 2012, and were stratified according to either MIS or open approach. Patients with a diagnosis of malignant neoplasm of the kidney were excluded. Following exclusions, 593 patients remained for analysis. Primary outcomes of interest were overall perioperative complications, need for transfusions, re-intervention rate, prolonged operation time (pOT), prolonged length of stay (pLOS), readmission and mortality within 30 days of surgery. Multivariable logistic regression analyses were performed to examine the association between preoperative outcomes and surgical approach. RESULTS: In this study, 423 (71.3 %) patients underwent MIP and 170 (28.7 %) underwent OP. Patients who underwent MIP had a decreased risk of wound [Odds ratio (OR) 0.06, p < 0.009] and overall complications (OR 0.21, p < 0.001), transfusions (OR 0.04, p = 0.004) and pLOS [pLOS (OR 0.08, p < 0.001)]. Conversely, MIP was associated with an increased likelihood of pOT (OR 2.26, p = 0.002). CONCLUSION: Adults with UPJO undergoing MIP have a lower risk of overall complications, transfusions and pLOS compared to OP. Further studies are needed to determine whether these benefits offset the increase in expenditures, related to longer operative time and costs of disposables.

An evaluation of the timing of surgical complications following nephrectomy: data from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).

PURPOSE: The rates of complications following radical/partial nephrectomy (RN/PN) are well known; however, the data regarding timing are opaque. Accordingly, we sought to assess the median time-to-event for 19 principal postoperative complications within 30 days following surgery. METHODS: Patients undergoing RN/PN were identified within the American College of Surgeons National Surgical Quality Improvement Program database (2005-2011). Primary endpoint was time-to-complication. Secondary endpoints included length-of-stay (LOS), re-intervention, re-admission and 30-day mortality. Multivariable regression models assessed the predictors for pre-/post-discharge complications and the effect of time-to-complication on secondary outcomes. RESULTS: Overall, 3820 patients underwent nephrectomy (RN = 63.6 %). The overall complication rate was 16.8 %, and the median LOS was 4 days. The majority of major complications (88.1 %), including bleeding/transfusion, renal, septic, deep venous thrombosis or pulmonary embolism, pulmonary, cardiac and neurologic, occurred prior to discharge. Conversely, the relatively minor complications, including wound and urinary tract infections, occurred predominantly post-discharge (70.7 %). The median time to major complications was 3 versus 13 days for minor complications. In multivariable analyses, age [odds ratio (OR) 1.02, p < 0.001], American Society of Anesthesiologists score ≥ 2 (p < 0.01) and PN (p < 0.001) were predictors of pre-discharge complications, while female gender (OR 1.67, p < 0.001), hypertension (OR 1.28, p = 0.007) and diabetes (OR 1.48, p < 0.001) were predictors of post-discharge complications. Creatinine ≥ 1.2 mg/dl and hematocrit < 30 increased (p < 0.01), whereas a minimally invasive approach decreased the odds (p < 0.05) for both pre-/post-discharge complications. For a given complication, time-to-complication did not affect the odds for mortality (p = 0.343) or re-intervention (p = 0.872). CONCLUSIONS: Approximately one in six patients suffers a complication following RN/PN; major complications tend to occur early with the majority occurring pre-discharge. Knowledge regarding the timing and risk factors for complications may facilitate improved patient-physician communication, both at admission and at discharge.

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.

Changing the Prostate Cancer Detection Paradigm: Clinical Application of European Association of Urology Guideline-recommended Magnetic Resonance Imaging-based Risk Stratification in Men with Suspected Prostate Cancer.

BACKGROUND: Multiparametric magnetic resonance imaging using the Prostate Imaging Reporting and Data System version 2.1 allows for a personalized, risk-stratified approach to indicating prostate biopsies (PBx) in order to reduce PBx and concomitant complications in men with suspected prostate cancer (PCa). One way to achieve this goal is to implement the risk-stratified pathway (RSP) using the Rotterdam Prostate Cancer Risk Calculator. OBJECTIVE: To describe the clinical implementation of the RSP and to examine its impact on the number of PBx and the resulting changes in the PCa detection pattern compared with men undergoing PBx in a detection-focused pathway (DFP) without prior risk assessment. DESIGN, SETTING, AND PARTICIPANTS: An institutional dataset of 505 consecutive patients with suspected PCa between July 2019 and February 2020 was used. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Chi-square test and Mann-Whitney U test were employed to examine differences in the number of PBx and the PCa detection pattern between the DFP (n = 195, 38.6%) and the RSP (n = 310, 61.4%). To minimize differences in risk stratification, inverse probability of treatment weighting was used. RESULTS AND LIMITATIONS: After implementing the RSP, the overall biopsy rate could be reduced by 11.2% (100% vs 88.8%, p < 0.001. Additionally, compared with the DFP, the number of biopsy cores per patient was reduced in the RSP (14 [interquartile range {IQR} 14-15] vs 14 [IQR 6-14], p < 0.001) and the detection of clinically significant PCa was increased (44.3% vs 57.7%, p = 0.038). Overdiagnosis of clinically insignificant disease was decreased in the RSP (22.8% vs 12.6%, p = 0.039). CONCLUSIONS: Implementation of the RSP in clinical practice reduced the number of PBx and brought forth a shift in the PCa detection pattern toward clinically significant disease, while reducing overdiagnosis of clinically insignificant disease. PATIENT SUMMARY: In this study, we examined the impact of risk stratification on the number of prostate biopsies (PBx) and the consecutive detection pattern in men with suspected prostate cancer (PCa). We found that the risk-stratified pathway reduced the number of PBx while simultaneously shifting the PCa detection pattern toward clinically significant PCa.