Prostate Specific Antigen Screening on a Nationwide Level: Featuring the Contribution of Race and Life Expectancy in Decision Making.

BACKGROUND: Estimation of life expectancy (LE) is important for the relative benefit of prostate specific antigen (PSA) screening. Limited data exists regarding screening for Black men with extended LE. The aim of the current study was to assess temporal trends in screening in United States (US) Black men with limited vs. extended LE, using a nationally representative dataset. MATERIALS AND METHODS: Using the National Health Institution Survey (NHIS) 2000 to 2018, men aged ≥40 without prior history of prostate cancer (PCa) who underwent PSA screening in the last 12 months were stratified into limited LE (ie, LE <15 years) and extended LE (ie, LE≥15 years) using the validated Schonberg index. LE-stratified temporal trends in PSA screening were analyzed for all men, and then in Black men. Weighted multivariable analyses and dominance analyses identified the predictors of PSA screening. RESULTS: PSA screening declined over the study period both for all eligible men with limited and extended LE, particularly between NHIS 2008 and 2013 (27.9%-20.7% in the extended). Screening increased significantly in Black men with extended LE (17.6% in 2010-25.7% in 2018). However, LE was not an independent predictor of screening in the Black cohort. Prior recipient of colonoscopy (55%-57%) and visit to health care provider (24%-32%) were the most important determinants for screening. CONCLUSION: For US men with extended LE, only 1 in 4 receive PSA screening, with a decline over the study-period. Screening rates increased for Black men. However, these changes were not driven by LE consideration itself, but participation in other screenings and access to a provider.

Robot-assisted radical prostatectomy: Advancements in surgical technique and perioperative care.

We reviewed the evolving strategies, practice patterns, and recent advancements aimed at improving the perioperative and surgical outcomes in patients undergoing robot-assisted radical prostatectomy for the management of localized prostate cancer.

Anti-Androgen Therapy Overcomes the Time Delay in Initiation of Salvage Radiation Therapy and Rescues the Oncological Outcomes in Men with Recurrent Prostate Cancer After Radical Prostatectomy: A Post Hoc Analysis of the RTOG-9601 Trial Data.

BACKGROUND: It is unknown whether the addition of anti-androgen therapy (AAT) to late salvage radiation therapy (sRT) can lead to oncological outcomes equivalent to that of early sRT in men with recurrent prostate cancer (CaP) after surgery. METHODS: Data on 670 men who participated in the Radiation Therapy Oncology Group (RTOG)-9601 trial and who experienced biochemical recurrence were extracted using the National Clinical Trials Network (NCTN) data archive platform. Patients were stratified into four treatment groups: early sRT (pre-sRT prostate-specific antigen [PSA] < 0.7 ng/mL) and late sRT (pre-sRT PSA ≥ 0.7 ng/mL) with/without concomitant AAT, based on cut-offs reported in the original trial. Time-varying Cox proportional hazards and Fine-Gray competing-risk regression analyses assessed the adjusted hazards of overall mortality, CaP-specific mortality, and metastasis among the four treatment groups. RESULTS: At 15-years (median follow-up of 14.7 years), for patients treated with early sRT, early sRT with AAT, late sRT, and late sRT with AAT, the overall mortality, CaP-specific mortality, and metastasis rates were 22.9, 22.8, 40.1, and 22.9% (log-rank p = 0.0039), 12.1, 3.9, 22.7, and 8.0% (Gray's p = 0.0004), and 18.8, 14.6, 35.9, and 19.5% (Gray's p = 0.0004), respectively. Time-varying multivariable adjusted analysis demonstrated increased hazards of overall mortality in patients receiving delayed sRT versus early sRT (hazards ratio [HR] 1.49, 95% confidence interval [CI] 1.02-2.17); however, no difference remained after the addition of concomitant AAT to late sRT (HR 0.85, 95% CI 0.55-1.32, referent early sRT). Likewise, the hazards of cancer-specific mortality and metastatic progression were worse for late sRT when compared with early sRT, but were no different after the addition of AAT to late sRT. CONCLUSIONS: Poorer outcomes associated with late sRT in men with recurrent CaP may be rescued by delivery of concomitant AAT.

Description of Surgical Technique and Oncologic and Functional Outcomes of the Precision Prostatectomy Procedure (IDEAL Stage 1-2b Study).

BACKGROUND: The existing treatment options for men with intermediate- or high-volume low-risk prostate cancer (PCa) are associated with a substantial risk of over- or undertreatment. The development of risk-adjusted therapies is an unmet need for these patients. OBJECTIVE: To describe our novel technique of precision prostatectomy, a form of surgical focal therapy that allows radical excision of the index PCa lesion along with >90% prostatic tissue extirpation while preserving the prostatic capsule and seminal vesicle/vas deferens complex on the side contralateral to the dominant cancer lesion, and to report on medium-term functional and oncologic outcomes in the first 88 consecutive men who underwent this procedure between December 2016 and January 2020. DESIGN, SETTING, AND PARTICIPANTS: Men with (1) prostate-specific antigen (PSA) ≤20 ng/ml, (2) clinical T stage ≤cT2, (3) a dominant unilateral lesion with Gleason ≤ 4 + 3 disease with any number or percentage of cores involved ipsilaterally on prostate biopsy, (4) no primary Gleason ≥4 lesion contralaterally, and (5) a preoperative Sexual Health Inventory of Men (SHIM) score of ≥17 (out of 25) with/without phosphodiesterase type-5 inhibitor use who consented to undergo precision prostatectomy were included in this single-arm, single-center, IDEAL stage 2b prospective development study. INTERVENTION: Robotic precision prostatectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The safety and urinary, sexual, and oncologic outcomes of the precision prostatectomy technique were studied. Descriptive statistics and Kaplan-Meier analyses were used to assess 12-mo urinary continence (0-1 pad), 12-mo sexual potency (SHIM score ≥17), 36-mo freedom from clinically significant PCa (grade group ≥2), secondary treatments, metastatic disease, and mortality. RESULTS AND LIMITATIONS: At study entry, the median age, PSA, and SHIM score were 60.0 yr (interquartile range [IQR] 54.2-65.9), 5.7 ng/ml (IQR 4.2-7.1), and 22 points (IQR 19-24), respectively. The median follow-up was 25 mo (IQR 14-38). At 12 mo, all patients were continent (0-1 pads), with 90.9% of patients using 0 pads. The median time to urinary continence was 1 mo (IQR 1-4). At 12 mo, 85% of all-comers and 90.2% of the preoperatively potent men were potent. The median time to sexual potency was 4 mo (IQR 4-12). From an oncologic standpoint, at 36 mo an estimated 93.4% of the patients were free from clinically significant residual PCa and 91.7% had not undergone any additional treatment. All patients were alive and free of metastatic disease at 36 mo. CONCLUSIONS: Precision prostatectomy is technically safe and reproducible and offers excellent postoperative functional results. At 36-mo follow-up, the oncologic outcomes and secondary treatment rates appear to be superior to existing ablative focal therapy results. Pending long-term data, a risk-stratified surgical approach to PCa may avoid whole-gland therapy and preserve functional quality of life in men with localized PCa. PATIENT SUMMARY: Precision prostatectomy is a new form of focal therapy for intermediate-risk prostate cancer in which a 5-10-mm rim of prostate capsule is left on the opposite side of the gland to where the dominant cancer is located. The technique appears to be safe and efficacious and adds to the growing armamentarium of risk-adapted therapies for treatment of localized prostate cancer that avoid the adverse effects on urinary and erectile function of whole-gland treatments.

High-intensity local treatment of clinical node-positive urothelial carcinoma of the bladder alongside systemic chemotherapy improves overall survival.

PURPOSE: Clinical node-positive urothelial carcinoma of the bladder (cN+UCaB) is a rapidly fatal disease with limited information on comparative-effectiveness of available treatment options. We sought to examine the impact of high-intensity vs. conservative local treatment (LT) regimens in management of these patients alongside systemic chemotherapy. MATERIALS AND METHODS: We identified 3,227 patients within the National Cancer Data Base who underwent multiagent systemic chemotherapy along with either high-intensity or conservative LT for primary cN+UCaB between 2004-2016. Patients who received no LT, TURBT alone, or <50 Gy radiation therapy to the bladder were included in the conservative group, while patients that received radical cystectomy with pelvic lymphadenectomy or ≥50 Gy radiation therapy with TURBT were included in the high-intensity group. Inverse probability of treatment weighting (IPTW) adjusted Kaplan-Meier and Cox regression analyses were used to assess overall survival (OS). Additionally, to assess whether the benefit of high-intensity LT differs by baseline mortality risk, we tested an interaction between 5-year predicted life-expectancy and the LT type. RESULTS: Overall, 784 (24.3%) and 2,443 (75.7%) cN+UCaB patients underwent high-intensity and conservative LT, respectively. IPTW-adjusted Kaplan-Meier analysis demonstrated OS to be significantly higher in the high-intensity group compared to the conservative group: 5-year OS 28.4% vs. 18.3%, respectively (Log-rank P<0.001). IPTW-adjusted multivariable Cox regression analysis confirmed the benefit of high-intensity LT in prolonging OS (HR 0.63, P<0.001). Interaction analysis showed that high-intensity LT approach was associated with longer OS in all patients regardless of their baseline 5-year life-expectancy (Pinteraction=0.79). CONCLUSION: Eligible patients with cN+UCaB should be considered for aggressive local treatment alongside multiagent systemic chemotherapy. Prospective trials are needed to validate these preliminary findings.

Managing Urology Consultations During COVID-19 Pandemic: Application of a Structured Care Pathway.

OBJECTIVE: To describe and evaluate a risk-stratified triage pathway for inpatient urology consultations during the SARS-CoV-2 (COVID-19) pandemic. This pathway seeks to outline a urology patient care strategy that reduces the transmission risk to both healthcare providers and patients, reduces the healthcare burden, and maintains appropriate patient care. MATERIALS AND METHODS: Consultations to the urology service during a 3-week period (March 16 to April 2, 2020) were triaged and managed via one of 3 pathways: Standard, Telemedicine, or High-Risk. Standard consults were in-person consults with non COVID-19 patients, High-Risk consults were in-person consults with COVID-19 positive/suspected patients, and Telemedicine consults were telephonic consults for low-acuity urologic issues in either group of patients. Patient demographics, consultation parameters and consultation outcomes were compared to consultations from the month of March 2019. Categorical variables were compared using Chi-square test and continuous variables using Mann-Whitney U test. A P value <.05 was considered significant. RESULTS: Between March 16 and April 2, 2020, 53 inpatient consultations were performed. By following our triage pathway, a total of 19/53 consultations (35.8%) were performed via Telemedicine with no in-person exposure, 10/53 consultations (18.9%) were High-Risk, in which we strictly controlled the urology team member in-person contact, and the remainder, 24/53 consultations (45.2%), were performed as Standard in-person encounters. COVID-19 associated consultations represented 18/53 (34.0%) of all consultations during this period, and of these, 8/18 (44.4%) were managed successfully via Telemedicine alone. No team member developed COVID-19 infection. CONCLUSION: During the COVID-19 pandemic, most urology consultations can be managed in a patient and physician safety-conscious manner, by implementing a novel triage pathway.

Ten-year disease progression and mortality rates in men who experience biochemical recurrence versus persistence after radical prostatectomy and undergo salvage radiation therapy: A post-hoc analysis of RTOG 9601 trial data.

PURPOSE: To compare local/metastatic disease progression and overall mortality rates in men with node-negative prostate cancer at radical prostatectomy (RP) that experience biochemical recurrence vs. persistence postoperatively and undergo salvage radiation therapy (sRT). MATERIALS AND METHODS: Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform. Patients were stratified into biochemical recurrence (nadir-PSA ≤0.4 ng/ml) or persistence (nadir-PSA >0.4 ng/ml) groups, based on the cut-off reported in the original trial. Inverse probability of treatment weighting (IPTW) methodology was utilized to minimize the baseline differences among groups. Competing-risk and Kaplan-Meier analyses estimated the impact of prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality in the IPTW-adjusted model; a 2-sided P < 0.05 was considered significant. RESULTS: All patients received sRT, and about 50% of the patients in either group received concomitant antiandrogen therapy (P = 0.951). The median follow-up was 12 years. After IPTW, the 2 groups were well-matched with standardized mean differences ∼10%. In the IPTW-adjusted cohort, the 10-year local and metastatic disease occurrence rates were 3.2% vs. 1.4% (Gray's P = 0.0001) and 28.6% vs. 10.1% (Gray's P < 0.0001) in patients with persistent vs. recurrent PSA, respectively. Similarly, the 10-year overall-mortality rates were 24.9% vs. 11.9% (Log-rank P = 0.029), respectively. CONCLUSIONS: Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use. These data may facilitate patient counseling and shared treatment selection.

The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study.

OBJECTIVE: This study aimed to develop a preclinical model of prostate cancer (CaP) for studying focal/hemiablation of the prostate (IDEAL stage 0), and to use the information from the stage 0 investigation to design a novel focal surgical treatment approach-the precision prostatectomy (IDEAL stage 1/2a). METHODS: The IDEAL stage 0 study included simulation of focal/hemiablation in whole-mount prostate specimens obtained from 100 men who had undergone radical prostatectomies, but met the criteria for focal/hemiablation. The IDEAL stage 1/2a was a prospective, single-arm, Institutional Review Board-approved study of precision prostatectomy undertaken in eight men, who met the predetermined criteria. Criteria for both stages included (1) prostate-specific antigen (PSA) ≤15 ng/mL, (2) stage ≤cT2, (3) dominant unilateral lesion with Gleason ≤4+3 with any number of cores or % cores involved ipsilaterally on transrectal biopsy, (4) no primary Gleason ≥4 contralaterally on transrectal biopsy, and (5) preoperative erectile function score (International Index of Erectile Function (IIEF)-5) of ≥17 (out of 25) without PDE-5i (applicable only to the stage 1/2a study participants). Feasibility and safety of the precision prostatectomy technique, and short-term urinary, sexual and oncological outcomes were studied. RESULTS: Analysis of whole-mount specimens in the 100 men showed an index lesion (>1 cm in diameter) in all. Ninety-eight men had satellite lesions smaller than 0.5 cm∧3 in volume-46 on the side of the dominant lesions and 52 in the contralateral lobe. If the men in this modeling cohort had undergone focal ablation with a 5-10 mm untreated margin, all except one would have had at least Gleason 6 residual cancer. If they had undergone hemiablation with no untreated tissue on the ablated side, 56 men would have had residual cancer on the contralateral side, of whom 21 would have had clinically significant cancer (Gleason 7 or higher). If these men had undergone precision prostatectomy, with preservation of 5-10 mm of tissue on the non-dominant side, 10% and 4% would have had Gleason 3+4 and Gleason 4+3 disease left behind, respectively. For the stage 1/2a study, the median (IQR) age, PSA and IIEF-5 scores at the time of surgery were 54 (52-57) years, 4.4 (3.8-6.1) ng/mL and 24 (23-25), respectively. All eight patients were continent and sexually active at 12 months with a median IIEF-5 score of 21 (out of 25). At 24-30 months from surgery, the median PSA was 0.2 (range 0.1-0.7) ng/mL. Six men had undergone follow-up protocol biopsies, two, with undetectable PSA, had refused. Two men had residual Gleason 3+3 cancer, with PSA of 0.7 and 0.4 ng/mL, and remain on active surveillance. No man has undergone secondary whole-gland therapy. CONCLUSIONS: Examination of whole-mount radical prostatectomy specimens in men who fit the conventional criteria of focal/hemiablation showed that approximately 21%-68% of men would have clinically significant CaP in the untreated tissue. In a small development cohort, precision prostatectomy was technically feasible, with excellent postoperative functional recovery. At 30 months of follow-up, no patient had clinically significant residual cancer or required secondary treatment. Pending long-term follow-up, a risk-stratified surgical approach may avoid whole-gland therapy and preserve erectile function in the majority of men with intermediate-risk CaP.

Initial robotic assistance in the surgical management of renal cell carcinoma with level 4 cavoatrial thrombus.

We report a case of left-sided renal cell carcinoma (RCC) with level 4 cavoatrial tumor thrombus where robotic assistance was used to achieve hemostasis around the kidney in order to minimize coagulopathic hemorrhage from the nephrectomy bed during subsequent open completion nephrectomy and cavoatrial thrombectomy under extracorporeal circulation and hypothermic circulatory arrest. Robotic assistance allowed for meticulous dissection and ligation of parasitic and arterial vessels to the kidney, release of renal attachments, and exposure of the inferior vena cava. The kidney was mobilized while leaving the renal vein attached and tumor thrombus undisturbed using a "minimal touch" technique. Open completion nephrectomy and cavoatrial thrombectomy was then performed. An experienced cardiac anesthesia team performed intraoperative cardiac monitoring, including trans-esophageal echocardiography. A cardiothoracic surgeon was immediately available throughout the case. Cardiopulmonary bypass was initiated within 60 min of open incision with a total duration a circulatory arrest time of 25 min. There was no bleeding from the nephrectomy bed during bypass despite heparinization and hypothermia. A left RCC with level 4 thrombus may be approached with initial robotic assistance to achieve hemostasis of the nephrectomy bed for subsequent open completion nephrectomy and cavoatrial thrombectomy under extracorporeal circulation and hypothermic circulatory arrest.

30-day adverse event rates following penile prosthesis surgery: an American College of Surgeons National Surgical Quality Improvement Program based evaluation.

BACKGROUND: Commonly utilized as a third-line therapy for erectile dysfunction (ED) management, the penile prostheses have become a staple treatment for ED refractory to pharmacological interventions. There is however a paucity of data in the literature pertaining to short-term adverse outcomes following penile prosthesis surgery. We thus sought to leverage the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) to evaluate such outcomes within 30 days of surgery in these patients. We hypothesized that such data will lead to a more informed patient-physician consultation. METHODS: Relying on the ACS-NSQIP database [2005-2013], patients undergoing penile prosthesis placement were identified utilizing the Current Procedural Terminology (CPT) codes: 54400, 54401, 54405, 54406, 54407, 54408, 54410, 54411, 54416 and 54417. Outcomes assessed included system-wise categorized complications, length-of-stay (LOS), and re-intervention, readmission and 30-day mortality rates. Descriptive statistics were used to analyze available data. Multivariate analysis could not be performed due to small sample size. RESULTS: Overall, 98 cases of patients who underwent surgery for penile prosthesis placements between the years 2005 and 2013 were reported by the ACS-NSQIP affiliated hospitals. The median age was 65 years (interquartile range, 58-70 years). The overall 30-day complication rate was 11.3% (n=11); 5 of the 11 complications were infectious in etiology, and three were a postoperative blood transfusion event. The median LOS was 1 day. One (1.0%) patient needed to return to the operating room, two patients (2.6%) were readmitted and there was one (1.0%) death within 30 days of the original surgery. CONCLUSIONS: Surgery for penile prosthesis appears to be a safe operation despite the routinely advanced age of the patients requiring it. Complications in the immediate postoperative setting are usually infectious. This data can be used in the clinical setting for a more informed patient-physician discussion and patient expectation management.

Emergency Department Utilization in Patients With Neurogenic Bladder: Contemporary Burden and National Trends in Prevalence, Inpatient Admission, and Associated Charges, 2006-2011.

OBJECTIVE: To quantify the national burden of neurogenic bladder disease, a chronic debilitating condition associated with frequent hospital visits, in the contemporary emergency care setting. METHODS: Relying on the Nationwide Emergency Department Sample, 2006-2011, we abstracted patients presenting to the emergency department (ED) with neurogenic bladder utilizing International Classification of Diseases, Ninth Revision (ICD-9) codes. National trends in ED presentation, subsequent inpatient admission vs discharge, and associated charges were examined using the estimated annual percent change methodology. RESULTS: Over the study period, a total of 875,066 patients with neurogenic bladder were seen in the ED, of which 538,532 (61.5%) were admitted. Total and median ED charges increased at an annual rate of 36.66% (P <.001) and 13.24% (P <.001), respectively, with total ED charges amounting to 87.48 million USD in the year 2011. Annual ED utilization also increased, although at a slower rate, 1.89% (P = .017). Inpatient admissions decreased at an annual rate of 3.67% (P <.001), whereas the use of long-term care facilities increased at 11.82% (P = .005). CONCLUSION: Total ED charges are increasing at a dramatic rate, driven by the increasing utilization of the ED as an entry point to health care as well as the increasing per-visit charges. Encouragingly, the rates of inpatient admission are decreasing, likely secondary to improved triaging in the ED and increased utilization of long-term care facilities. It remains to be seen, however, whether the increased spending in the ED for better triaging and investment in long-term care facilities will translate into an overall economic benefit by reducing inpatient charges or not.

Understanding the Economic Impact of Neurogenic Lower Urinary Tract Dysfunction.

Neurogenic bladder is a chronic and disabling condition associated with multiple comorbidities and a widespread economic impact. Literature on cost of care and resource utilization is sparse and heterogeneous. Nonstandardized approaches, impact perspectives, and types of costs are used to describe the economic implications of neurogenic bladder. The financial toll is difficult to ascertain due to indirect and intangible costs exacerbated by the underlying disability. Health resource utilization based on clinical manifestations of neurogenic bladder may serve as an alternative measure. Understanding the multifold economic implications and health resource utilization patterns of neurogenic bladder may guide improvement of treatment strategies.