Systemic and tumor-directed therapy for oligometastatic prostate cancer: study protocol for a phase II trial for veterans with de novo oligometastatic disease.

BACKGROUND: The treatment paradigm for metastatic hormone-sensitive prostate cancer (mHSPC) patients is evolving. PET/CT now offers improved sensitivity and accuracy in staging. Recent randomized trial data supports escalated hormone therapy, local primary tumor therapy, and metastasis-directed therapy. The impact of combining such therapies into a multimodal approach is unknown. This Phase II single-arm clinical trial sponsored and funded by Veterans Affairs combines local, metastasis-directed, and systemic therapies to durably render patients free of detectable disease off active therapy. METHODS: Patients with newly-diagnosed M1a/b prostate cancer (PSMA PET/CT staging is permitted) and 1-5 radiographically visible metastases (excluding pelvic lymph nodes) are undergoing local treatment with radical prostatectomy, limited duration systemic therapy for a total of six months (leuprolide, abiraterone acetate with prednisone, and apalutamide), metastasis-directed stereotactic body radiotherapy (SBRT), and post-operative fractionated radiotherapy if pT ≥ 3a, N1, or positive margins are present. The primary endpoint is the percent of patients achieving a serum PSA of < 0.05 ng/mL six months after recovery of serum testosterone ≥150 ng/dL. Secondary endpoints include time to biochemical progression, time to radiographic progression, time to initiation of alternative antineoplastic therapy, prostate cancer specific survival, health related quality-of-life, safety and tolerability. DISCUSSION: To our knowledge, this is the first trial that tests a comprehensive systemic and tumor directed therapeutic strategy for patients with newly diagnosed oligometastatic prostate cancer. This trial, and others like it, represent the critical first step towards curative intent therapy for a patient population where palliation has been the norm. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03298087 (registration date: September 29, 2017).

Correlation between the European System for Cardiac Operative Risk Evaluation and sexual function after coronary artery bypass graft surgery.

INTRODUCTION: The published studies discussing the prognostic factors for expected sexual function after coronary artery bypass graft (CABG) are still limited. AIM: Examining the correlation between the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and the abridged form of International Index of Erectile Function questionnaire (IIEF-5), as a quick and inexpensive tool for the cardiologist to predict the sexual function after CABG. MAIN OUTCOME MEASURES: Validated standardized questionnaire commonly used by cardiologists in identifying appropriate weight to various risk factors related to adult cardiac operations. METHODS: Preoperatively patients were evaluated as regards to the sexual function by (IIEF-5) and pharmaco-penile duplex ultrasound. Moreover all patients were evaluated bu EuroSCORE. Six months after surgery, the erectile function of all patients was revaluated according to the same preoperative procedures. The patients were categorized with EuroSCORE as follows: The low-risk group (EuroSCORE 0­2), the medium-risk group (EuroSCORE 3­5), and the high-risk group (EuroSCORE 6 plus). RESULTS: The EuroSCORE was negatively correlated with the IIEF-5 score (r = -0.224, P = 0.025 or rs = -0.259, P = 0.009). Moreover, low-risk patients had significantly higher IIEF-5 scores compared with medium-risk patients (mean standard deviation = 15.27 6.03 vs. 12.18 6.07, P < 0.05). CONCLUSIONS: There is an inverse correlation between the components of EuroSCORE and the IIEF-5 score. Patients with higher EuroSCORE had lower IIEF-5 scores and vice versa. The EuroSCORE is a useful, quick, and inexpensive tool that allows prediction of ED in those patients with coronary artery disease patients who are undergoing CABG.

Vascular risk factors as predictors of sexual function following coronary artery bypass graft.

INTRODUCTION: A strong association between cardiovascular risk factors and erectile dysfunction (ED) was suggested. Coronary artery bypass grafting (CABG) is the gold standard for surgical myocardial revascularization. AIM: We herein evaluate the impact of vascular risk factors on postoperative sexual functions in patients undergo CABG. MAIN OUTCOME MEASURES: ED severity by the International Index of Erectile Function (IIEF-5) and penile duplex study. METHODS: The present study included 100 patients who underwent CABG. The patients were evaluated by an abridged form of the IIEF-5 questionnaire, followed by CABG. Six months after surgery the erectile function of all patients was re-evaluated utilizing the IIEF-5. RESULTS: Number of risk factors was significantly associated with postoperative change in IIEF-5 score (P = 0.02). A post hoc analysis of the association revealed that patients with one risk factor were significantly more likely to have increased IIEF-5 scores (N = 18), whereas those with two or more risk factors were significantly more likely to have decreased IIEF-5 scores (N = 21, P < 0.05). Furthermore, those with no risk factors were significantly more likely to be stable (N = 8) compared with those with more than two risk factors, who were more likely to have decreased scores (P < 0.05). The hierarchical logistic regression results showed that when examining all risk factors simultaneously, because of multicollinearity, only hyperlipidemia was significantly associated with postoperative ED (odds ratio [OR] = 11.33, confidence interval [CI] = 1.25, 102.82). Frequency of intercourse was also significantly associated with postoperative ED after controlling for risk factors (OR = 0.71, CI = 0.52, 0.97). CONCLUSIONS: This data clearly shows that the number of cardiovascular risk factors is an essential predictive factor for sexual function following surgery. Only hyperlipidemia may play a predictive role for the future sexual function of patients undergo CABG.

The impact of on-pump coronary artery bypass surgery vs. off-pump coronary artery bypass surgery on sexual function.

INTRODUCTION: Erectile dysfunction and ischemic heart disease are common health problems that affect elderly individuals. Despite advances in treatment strategies, cardiopulmonary bypass (CPB) has been used for coronary artery bypass grafting (CABG) for over three decades for surgical myocardial revascularization. AIM: To discuss the difference between the on pump and the newer alternative-the off-pump CABG (OPCABG) surgery-on the sexual function. METHODS: This prospective study included 100 patients who underwent CABG. MAIN OUTCOME MEASURES: The patients were evaluated by an abridged form of International Index of Erectile Function questionnaire (IIEF-5), Pharmaco-Penile Duplex Ultrasound and finally by the European System for Cardiac Operative Risk Evaluation. The patients were underwent either on-pump CABG or OPCABG. Six months after surgery, the erectile function was revaluated according to the same preoperative measures. RESULTS: Patients included in the study were classified into two matched groups: group I-patients who underwent on-pump CABG (N = 50); and group II-patients who underwent OPCABG (N = 50). The frequency of intercourse was significantly higher in OPCABG (P < 0.05) after surgery. The mean +/- standard deviation of the IIEF-5 scores of the on-pump group postoperatively became 12.48 +/- 7.19 whereas it became 15.88 +/- 6.67 in the off-pump group (P < 0.05). Moreover, the number of patients who reported postoperative improvement of their IIEF-5 score was significantly higher in OPCABG group (N = 23) compared with the conventional on-pump CABG group (N = 13) (P < 0.05). There was no significant change in the duplex ultrasound after surgery between both groups. CONCLUSIONS: The OPCABG has a diminished impact on the sexual function of patients compared with the conventional on-pump CABG. Therefore, the type of operation can be considered a predictive factor of sexual function following CAB surgery.

Best practice policy statement on urologic surgery antimicrobial prophylaxis.

PURPOSE: Antimicrobial prophylaxis is the periprocedural systemic administration of an antimicrobial agent intended to reduce the risk of postprocedural local and systemic infections. The AUA convened a BPP Panel to formulate recommendations on the use of antimicrobial prophylaxis during urologic surgery. MATERIALS AND METHODS: Recommendations are based on a review of the literature and the Panel members' expert opinions. RESULTS: The potential benefit of antimicrobial prophylaxis is determined by patient factors, procedure factors, and the potential morbidity of infection. Antimicrobial prophylaxis is recommended only when the potential benefit outweighs the risks and anticipated costs (including expense of agent and administration, risk of allergic reactions or other adverse effects, and induction of bacterial resistance). The prophylactic agent should be effective against organisms characteristic of the operative site. Cost, convenience, and safety of the agent also should be considered. The duration of antimicrobial prophylaxis should extend throughout the period when bacterial invasion is facilitated and/or likely to establish an infection. Prophylaxis should begin within 60 minutes of the surgical incision (120 minutes for intravenous fluoroquinolines and vancomycin) and generally should be discontinued within 24 hours. The AHA no longer recommends antimicrobial prophylaxis for genitourinary surgery solely to prevent infectious endocarditis. Justifications and recommendations for specific antimicrobial prophylactic regimens for specific categories of urologic procedures are provided. CONCLUSIONS: The recommendations provided in this document, including specific indications and agents enumerated in the Tables, can assist urologists in the appropriate use of periprocedural antimicrobial prophylaxis.

A Proof-of-Concept Study of Transcutaneous Magnetic Spinal Cord Stimulation for Neurogenic Bladder.

Patients with chronic spinal cord injury (SCI) cannot urinate at will and must empty the bladder by self-catheterization. We tested the hypothesis that non-invasive, transcutaneous magnetic spinal cord stimulation (TMSCS) would improve bladder function in individuals with SCI. Five individuals with American Spinal Injury Association Impairment Scale A/B, chronic SCI and detrusor sphincter dyssynergia enrolled in this prospective, interventional study. After a two-week assessment to determine effective stimulation characteristics, each patient received sixteen weekly TMSCS treatments and then received "sham" weekly stimulation for six weeks while bladder function was monitored. Bladder function improved in all five subjects, but only during and after repeated weekly sessions of 1 Hz TMSCS. All subjects achieved volitional urination. The volume of urine produced voluntarily increased from 0 cc/day to 1120 cc/day (p = 0.03); self-catheterization frequency decreased from 6.6/day to 2.4/day (p = 0.04); the capacity of the bladder increased from 244 ml to 404 ml (p = 0.02); and the average quality of life ranking increased significantly (p = 0.007). Volitional bladder function was re-enabled in five individuals with SCI following intermittent, non-invasive TMSCS. We conclude that neuromodulation of spinal micturition circuitry by TMSCS may be used to ameliorate bladder function.

Advance Care Planning and Patient Preferences in a Feasibility Pilot Study to Improve End-of-Life Communication among Men with Metastatic Urological Malignancies.

INTRODUCTION: Rates of advance care planning for patients with cancer are poor despite efforts to enhance discussions regarding goals of care. Good patient-physician communication is critical to providing quality end-of-life care and, thus, it is important to identify effective interventions to improve systems through which patient preferences are addressed. METHODS: To improve rates of advance care planning as well as examine patient preferences regarding end-of-life care, we developed an integrated urology-palliative care clinic. All patients with a new diagnosis of a metastatic urological malignancy or castration resistant prostate cancer seen in a urology clinic within the Veterans Affairs Greater Los Angeles Healthcare System were offered a palliative care referral to be performed immediately after their urology appointment. The primary outcome was completion of an advance directive or POLST (Physician Orders for Life-Sustaining Treatment) form and the secondary outcome was patient preference regarding end-of-life care. RESULTS: A total of 59 patients were enrolled in the study between February 2012 and October 2016, and no patients were lost or excluded. There were 25 eligible patients who declined enrollment. Overall 85% of patients completed an advance directive or POLST form, and 98% chose to withhold cardiopulmonary resuscitation, advanced cardiac life support and artificially administered nutrition. CONCLUSIONS: High levels of advance care planning are achievable in an integrated urology-palliative care clinic and the majority of patients with a terminal illness are averse to aggressive end-of-life care.

Variations in payment patterns for surgical care in the centers for Medicare and Medicaid Services.

BACKGROUND: We investigated provider and regional variation in payments made to surgeons by the Centers for Medicare & Medicaid Services (CMS) by indexing payments to unique beneficiaries treated and examined the proportion of charges that resulted in payments. Understanding variation in care within CMS may prove actionable by identifying modifiable, and potentially unwarranted, variations. METHODS: We analyzed the Medicare Part B Provider Utilization and Payment Data released by CMS for 2012. We included Medicare B participants in the fee-for-service program. We calculated for each provider the ratio of number of services provided to individual beneficiaries, and the ratio of total submitted charges to total Medicare payments. We also categorized each provider into deciles of total Medicare payments, and calculated the means per decile of total Medicare payment for surgeons and urologists. To determine any associations with ratio of services to beneficiaries, we conducted multivariate linear regressions. RESULTS: The 20th, 40th, 60th, and 80th percentiles for the services-per-beneficiary ratios are 1.6, 2.2, 3.1, and 5.0, respectively (n = 83,376). Greater-earning surgeons offered more services per beneficiary, with a precipitous increase from the lowest decile to the highest. Charges were consistently greater than payments by a factor of 3. In our multivariate analysis of services per beneficiary ratio, female providers had lower ratios (P < .01), and we noted significant regional variation in the ratio of services per unique beneficiary (P < .001 for each of the 10 Standard Federal Regions). CONCLUSION: We found significant variation in patterns of payments for surgical care in CMS.

Engaging Physician Learners Through a Web-Based Platform: Individualized End-of-Life Education.

BACKGROUND: Web-based modules provide a convenient and low-cost education platform, yet should be carefully designed to ensure that learners are actively engaged. In order to improve attitudes and knowledge in end-of-life (EOL) care, we developed a web-based educational module that employed hyperlinks to allow users access to auxiliary resources: clinical guidelines and seminal research papers. METHODS: Participants took pre-test evaluations of attitudes and knowledge regarding EOL care prior to accessing the educational module, and a post-test evaluation following the module intervention. We recorded the type of hyperlinks (guideline or paper) accessed by learners, and stratified participants into groups based on link type accessed (none, either, or both). We used demographic and educational data to develop a multivariate mixed-effects regression analysis to develop adjusted predictions of attitudes and knowledge. RESULTS: 114 individuals participated. The majority had some professional exposure to EOL care (prior instruction 62%; EOL referral 53%; EOL discussion 56%), though most had no family (68%) or personal experience (51%). On bivariate analysis, non-partnered (p = .04), medical student training level (p = .03), prior palliative care referral (p = .02), having a family member (p = .02) and personal experience of EOL care (p < .01) were all associated with linking to auxiliary resources via hyperlinks. When adjusting for confounders, ß coefficient estimates and least squares estimation demonstrated that participants clicking on both hyperlink types were more likely to score higher on all knowledge and attitude items, and demonstrate increased score improvements. CONCLUSION: Auxiliary resources accessible by hyperlink are an effective adjunct to web-based learning in end-of-life care.

Community-Partnered Collaboration to Build an Integrated Palliative Care Clinic: The View From Urology.

BACKGROUND: We partnered with patients, families, and palliative care clinicians to develop an integrated urology-palliative care clinic for patients with metastatic cancer. We assessed clinician satisfaction with a multidisciplinary palliative care clinic model. METHODS: We conducted semi-structured interviews with 18 clinicians who practice in our integrated clinic. We analyzed transcripts using a multistage, cutting-and-sorting technique in an inductive approach based on grounded theory analysis. Finally, we administered a validated physician job satisfaction survey. RESULTS: Clinicians found that referring a patient to palliative care in the urology clinic was feasible and appropriate. Patients were receptive to supportive care, and clinicians perceived that quality of care improved following the intervention. CONCLUSION: An integrated, patient-centered model for individuals with advanced urologic malignancies is feasible and well received by practitioners.

Emergency department revisits for patients with kidney stones in California.

OBJECTIVES: Kidney stones affect nearly one in 11 persons in the United States, and among those experiencing symptoms, emergency care is common. In this population, little is known about the incidence of and factors associated with repeat emergency department (ED) visits. The objective was to identify associations between potentially mutable factors and the risk of an ED revisit for patients with kidney stones in a large, all-payer cohort. METHODS: This was a retrospective cohort study of all patients in California initially treated and released from EDs for kidney stones between February 2008 and November 2009. A multivariable regression model was created to identify associations between patient-level characteristics, area health care resources, processes of care, and the risk of repeat ED visits. The primary outcome was a second ED visit within 30 days of the initial discharge from emergent care. RESULTS: Among 128,564 patients discharged from emergent care, 13,684 (11%) had at least one additional emergent visit for treatment of their kidney stone. In these patients, nearly one in three required hospitalization or an urgent temporizing procedure at the second visit. On multivariable analysis, the risk of an ED revisit was associated with insurance status (e.g., Medicaid vs. private insurance; odds ratio [OR] = 1.52, 95% confidence interval [CI] = 1.43 to 1.61; p < 0.001). Greater access to urologic care was associated with lower odds of an ED revisit (highest quartile OR = 0.88, 95% CI = 0.80 to 0.97; p < 0.01 vs. lowest quartile). In exploratory models, performance of a complete blood count was associated with a decreased odds of revisit (OR = 0.86, 95% CI = 0.75 to 0.97; p = 0.02). CONCLUSIONS: Repeat high-acuity care affects one in nine patients discharged from initial emergent evaluations for kidney stones. Access to urologic care and processes of care are associated with lower risk of repeat emergent encounters. Efforts are indicated to identify preventable causes of ED revisits for kidney stone patients and design interventions to reduce the risk of high-cost, high-acuity, repeat care.

A Scalable Web-Based Module for Improving Surgical and Medical Practitioner Knowledge and Attitudes about Palliative and End-of-Life Care.

BACKGROUND: We built a web-based, interactive, self-directed learning module about end-of-life care. OBJECTIVE: The study objective was to develop an online module about end-of-life care targeted at surgeons, and to assess the effect of the module on attitudes towards and knowledge about end-of-life care. METHODS: Informed by a panel of experts in supportive care and educational assessment, we developed an instrument that required approximately 15 minutes to complete. The module targets surgeons, but is applicable to other practitioners as well. We recruited general surgeons, surgical subspecialists, and medical practitioners and subspecialists from UCLA and the GLA-VA (N=114). We compared pre- and post-intervention scores for attitude and knowledge, then used ANOVA to compare the pre- and postmodule means for each level of the covariate. We performed bivariable analyses to assess the association of subject characteristic and change in score over time. We ran separate analyses to assess baseline and change scores based on the covariates we had selected a priori. RESULTS: Subjects improved meaningfully in all five domains of attitude and in each of the six knowledge items. Individuals younger than 30 years of age had the greatest change in attitudes about addressing pain, addressing end-of-life goals, and being actively involved as death approached; they also had the most marked improvement in total knowledge score. Having a family member die of cancer within the last five years or a personal experience with palliative care or hospice were associated with higher change scores. CONCLUSIONS: A web-based education module improved surgical and medical provider attitudes and knowledge about end-of-life care.

Exclusion of the uniform tetraploid cells significantly improves specificity of the urine FISH assay.

The urine fluorescence in situ hybridization (FISH) assay (UroVysion™), with the current scoring criteria, has a higher sensitivity than routine cytopathology but a lower specificity. Among 215 urine FISH tests we performed, 45 had associated histopathology and clinical follow up. In this study, a cell with four signals for each probe was classified as a uniform tetraploid cell (UTC); a presumed reparative cell which is currently classified as an abnormal cell in the FDA approved assay. By using the existing criteria, the tests were scored as positive or negative before and after exclusion of the UTCs. Before the exclusion, 24 positive, 13 negative, seven false positive, and one false negative result were obtained with 96% sensitivity and 65% specificity. After the exclusion, the results changed to 22 positive, 19 negative, one false positive, and three false negatives resulting in a 88% sensitivity of 88% and a 95% specificity; a significant improvement in the specificity. We conclude that exclusion of the UTCs as abnormal cells would result in a more solid performance of the FISH assay.

Urologist attitudes toward end-of-life care.

OBJECTIVE: To examine urology trainees' views about the quality and current practices of end-of-life care and to explore strategies for improving integration and quality of care. METHODS: We conducted semi-structured interviews with 20 trainees from 4 institutions in different regions of the United States. Open-ended questions allowed participants to express themselves independently, and follow-up discussions explored their perception of current end-of-life practices, as well as avenues for future integration and improvement. We analyzed transcripts using a multistage, cutting-and-sorting technique in an inductive approach based on grounded theory analysis. RESULTS: Clinicians agreed that their patients do not currently receive ideal care and were interested in joining a team geared towards improving care at the end of life. They expressed a preference for a multidisciplinary team, although the precise role each wanted to play within the team varied. Better identification of depression, pain, and patient-centered goals to allow value-congruent care were high in priorities for improvement. Trainees cited the lack of an educational curriculum on end-of-life care as a barrier to improving care and expressed a desire for formal education on this topic. CONCLUSION: Urology trainees believe that end-of-life care can be improved and are interested in participating as part of a multidisciplinary team to better care for these individuals. There was consensus that end-of-life care should be formally taught to all intern and resident physicians and care at the end of life should be integrated to pursue value-congruent care for each patient.

Carcinoma of the prostate presenting as a painful parotid mass with mandibular invasion: a case report.

Prostate cancer metastatic to the parotid gland is exceedingly rare, as only 10 cases have been previously reported in the literature. Symptoms may mimic a parotid infection or suggest a primary parotid tumor. We report a new case of carcinoma of the prostate metastatic to the parotid. The tumor was painful and had invaded the mandible. Fine-needle aspiration of the mass and immunohistochemical staining for prostate-specific antigen confirmed the diagnosis. The patient died 1 month later of an unrelated cause.

Supraclavicular lymph node: incidence of unsuspected metastatic prostate cancer.

An uncommon presentation of prostate carcinoma to the supraclavicular lymph nodes is herein reviewed. With prompt diagnosis and treatment, patient survival can be extended. A high index of suspicion is necessary to make the diagnosis. The clinical features of four cases involving metastatic prostate carcinoma will be discussed.