Publications by authors named "Daniel A Barocas"

152 Publications

Association between pelvic nodal radiotherapy and patient-reported functional outcomes through 5 years among men undergoing external-beam radiotherapy for prostate cancer: An assessment of the comparative effectiveness analysis of surgery and radiation (CEASAR) cohort.

Urol Oncol 2021 Jun 18. Epub 2021 Jun 18.

Department of Radiation Oncology, The University of Texas MD Anderson Center, Houston, TX.

Background: The role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years.

Materials And Methods: We performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT).

Results: 587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue.

Conclusion: This prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.
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http://dx.doi.org/10.1016/j.urolonc.2021.04.035DOI Listing
June 2021

Differential effect of body mass index by gender on oncological outcomes in patients with renal cell carcinoma.

J Cancer Res Ther 2021 Apr-Jun;17(2):420-425

Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.

Objectives: To investigate the relationship between gender, body mass index (BMI), and prognosis in renal cell carcinoma (RCC) patients.

Materials And Methods: We retrospectively reviewed 1353 patients with RCC who underwent a partial or radical nephrectomy between 1988 and 2015. The association among sex, BMI, stage, grade, overall survival (OS), and recurrence-free survival (RFS) was analyzed.

Results: The median age of the patients was 59.4 ± 11.9 years. Female patients had proportionally lower grade tumors than male patients (Grade I-II in 75.5% vs. 69.3% in women and men, respectively, P = 0.022). There was no relationship between Fuhrman grade and BMI when substratified by gender (p > 0.05). There was a nonsignificant trend toward more localized disease in female patients (p = 0.058). There was no relationship between T stage and BMI when stratified by gender (p > 0.05). Patients with higher BMI had significantly better OS (p = 0.0004 and P = 0.0003) and RFS (P = 0.0209 and P =0.0082) whether broken out by lower 33 or 25 percentile. Male patients with higher BMI had significantly better OS and RFS rates. However, there was no relationship between BMI and OS or RFS for female patients (P > 0.05). Multivariate analysis of the entire cohort demonstrated that a BMI in the lower quartile independently predicts OS (hazard ratio 1.604 [95% confidence interval: 1.07-2.408], P = 0.022) but not RFS (P > 0.05). When stratified by gender, there was no relationship between BMI and either OS or RFS (P > 0.05).

Conclusions: Increasing BMI was associated with RCC prognosis. However, the clinical association between BMI and oncologic outcomes may be different between men and women.
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http://dx.doi.org/10.4103/jcrt.JCRT_546_18DOI Listing
June 2021

Sexual function outcomes of radiation and androgen deprivation therapy for localized prostate cancer in men with good baseline function.

Prostate Cancer Prostatic Dis 2021 Jun 9. Epub 2021 Jun 9.

Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA.

Background: Sexual dysfunction, including erectile dysfunction and loss of libido, are common among men undergoing treatment for localized prostate cancer. Both local treatments and systemic androgen deprivation therapy may contribute to these outcomes and are differentially indicated based on disease characteristics. We sought to compare sexual function through 5 years after radiation treatment with and without androgen deprivation therapy in men with good baseline sexual function to better understand long-term effects in this understudied subset of patients.

Methods: We retrospectively reviewed a prospectively assembled population-based cohort of men who underwent radiation with and without androgen deprivation therapy for intermediate or high-risk localized prostate cancer. Sexual function was assessed longitudinally over 5 years. Men with erections sufficient for intercourse at baseline were selected for inclusion.

Results: Out of 167 patients included, 73 underwent radiation alone and 94 received androgen deprivation therapy plus radiation (51 with intermediate and 43 with high-risk disease). Androgen deprivation therapy use was associated with worse sexual function through 1 year regardless of disease risk. This difference was no longer statistically significant at 3 years in the intermediate-risk group. Compared to radiation alone, androgen deprivation therapy in high-risk disease was associated with worse sexual function at 3 years (effect: -20.3 points, CI [-31.8, -8.8], p < 0.001) but not at 5 years (effect: -3.4, CI [-17.2, 10.5], p = 0.63).

Conclusions: Androgen deprivation therapy plus radiation is associated with worse sexual function through 3-years follow-up in men with high-risk prostate cancer compared to radiation alone. The addition of androgen deprivation therapy in the treatment of intermediate-risk disease does not appear to result in worse sexual function at 3 or 5-year follow-up compared to radiation alone.
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http://dx.doi.org/10.1038/s41391-021-00405-5DOI Listing
June 2021

Urinary-based tumor markers enhance microhematuria risk stratification according to baseline bladder cancer prevalence.

Urol Oncol 2021 Apr 12. Epub 2021 Apr 12.

Department of Urology, University of Texas Southwestern Medical Center Dallas, Dallas, TX. Electronic address:

Introduction: The 2020 AUA microhematuria (MH) guideline stratifies patients into low, intermediate and high-risk for urologic malignancy based on established risk-factors for urothelial carcinoma. Notably, urine-based tumor markers (UBTMs) were not included in the risk classification. We evaluated the impact of incorporating UBTMs (cytology and multiple commercially available UBTMs) into this risk stratification.

Methods: We performed a systematic review of performance characteristics of UBTMs for the detection of bladder cancer during hematuria evaluation, pooled the reported sensitivity and specificity, and calculated positive and negative likelihood ratios (LR). These were then applied to the estimated pre-test probability for the diagnosis for each AUA risk strata: low-risk 0.5%, intermediate-risk 1.0%, and high-risk (2%-3%) in order to calculate a post-test probability of bladder cancer in the event of a positive or negative test.

Results: The pooled sensitivity for urinary cytology and commercially available UBTMs was 68% and 58%-95%, respectively while the specificity was estimated at 91% and 34%-90%, respectively. The positive LRs of UBTMs ranged from 2.1-7.67 and negative LRs ranged from 0.07-0.48. A negative UBTM was associated with a post-test probability of cancer for low, intermediate, and high-risk patients of 0-0.2%, 0.2%-0.5%, and 0.4%-1.1%, respectively. In the setting of a positive UBTM, the post-test probability of cancer for low, intermediate, and high-risk patients was 1.1%-3.7%, 2.1%-7.8%, 4.2%-19.2%, respectively.

Conclusion: Pending prospective validation, UBTMs may be able to enhance risk stratification and inform shared decision-making over clinical factors alone and allow for re-classification of patients into higher or lower risk categories.
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http://dx.doi.org/10.1016/j.urolonc.2021.03.022DOI Listing
April 2021

Five-year outcomes from a prospective comparative effectiveness study evaluating external-beam radiotherapy with or without low-dose-rate brachytherapy boost for localized prostate cancer.

Cancer 2021 Jun 17;127(11):1912-1925. Epub 2021 Feb 17.

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Background: To inform patients who are in the process of selecting prostate cancer treatment, the authors compared disease-specific function after external-beam radiotherapy (EBRT) alone versus EBRT plus a low-dose-rate (LDR) brachytherapy boost (EBRT-LDR).

Methods: For this prospective study, men who had localized prostate cancer in 2011 and 2012 were enrolled. Assessments at baseline, 0.5, 1, 3, and 5 years included the patient-reported Expanded Prostate Index Composite, the 36-item Medical Outcomes Study Short-Form Health Survey, and treatment-related regret. Regression models were adjusted for baseline function and for patient and treatment characteristics. The minimum clinically important difference in scores on the Expanded Prostate Index Composite 26-item instrument was from 5 to 7 for urinary irritation and from 4 to 6 for bowel function.

Results: Six-hundred ninety-five men met inclusion criteria and received either EBRT (n = 583) or EBRT-LDR (n = 112). Patients in the EBRT-LDR group were younger (median age, 66 years [interquartile range [IQR], 60-71 years] vs 69 years [IQR, 64-74 years]; P < .001), were less likely to receive pelvic radiotherapy (10% vs 18%; P = .040), and had higher baseline 36-item Medical Outcomes Study Short-Form Health Survey physical function scores (median score, 95 [IQR, 86-100] vs 90 [IQR, 70-100]; P < .001). Over a 3-year period, compared with EBRT, EBRT-LDR was associated with worse urinary irritative scores (adjusted mean difference at 3 years, -5.4; 95% CI, -9.3, -1.6) and bowel function scores (-4.1; 95% CI, -7.6, -0.5). The differences were no longer clinically meaningful at 5 years (difference in urinary irritative scores: -4.5; 95% CI, -8.4, -0.5; difference in bowel function scores: -2.1; 95% CI, -5.7, -1.4). However, men who received EBRT-LDR were more likely to report moderate or big problems with urinary function bother (adjusted odds ratio, 3.5; 95% CI, 1.5-8.2) and frequent urination (adjusted odds ratio, 2.6; 95% CI, 1.2-5.6) through 5 years. There were no differences in survival or treatment-related regret between treatment groups.

Conclusions: Compared with EBRT alone, EBRT-LDR was associated with clinically meaningful worse urinary irritative and bowel function over 3 years after treatment and more urinary bother at 5 years.

Lay Summary: In men with prostate cancer who received external-beam radiation therapy (EBRT) with or without a brachytherapy boost (EBRT-LDR), EBRT-LDR was associated with clinically worse urinary irritation and bowel function through 3 years but resolved after 5 years. Men who received EBRT-LDR continued to report moderate-to-big problems with urinary function bother and frequent urination through 5 years. There was no difference in treatment-related regret or survival between patients who received EBRT and those who received EBRT-LDR. These intermediate-term estimates of function may facilitate counseling for men who are selecting treatment.
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http://dx.doi.org/10.1002/cncr.33388DOI Listing
June 2021

The prevention of extraction site incisional hernia after robotic-assisted radical prostatectomy.

J Robot Surg 2021 Apr 2;15(2):315-317. Epub 2021 Feb 2.

Department of Urologic Surgery, Vanderbilt University Medical Center, 1211 Medical Center Drive, Nashville, TN, USA.

Extraction site incisional hernia (IH) has been recognized as an important complication in minimally invasive procedures but has not been as well characterized following robotic-assisted laparoscopic prostatectomy (RALP). Approximately 29% of IH required surgical repair. A number of techniques have been utilized to reduce the rates of IH following minimally invasive procedures. First, off-midline extraction was investigated, this did not demonstrate a reduction in incisional hernia rates. Recently, supra-umbilical transverse incisions have been utilized to extract prostate specimen and this method decreased the extraction site IH rate compared to the vertical midline incision. In addition, the choice of fascial closure technique and choice of the suture may influence the incidence of extraction site IH. For example, studies showed that abdominal fascial closure using a nonabsorbable suture and a continuous running suture technique decreased IH rate from 32 to 17%. Finally, "the small bites technique" has been recommended to reduce hernia incidence after midline fascial closure following a randomized controlled trial (RCT) which demonstrated the superiority of the small-bite technique. In summary, a supra-umbilical transverse incision to extract the specimen was shown to decrease the rate of extraction site IH. In vertical midline incisional closure, the small bites technique with slowly- or non-absorbable suture, such as #0 or 2-0 PDS II with SH or CT-2 needle (26 mm arch length), reduces the IH rate. Urologists should consider this data to reduce the risk of IH following RALP.
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http://dx.doi.org/10.1007/s11701-021-01204-9DOI Listing
April 2021

Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria.

J Urol 2021 May 24;205(5):1387-1393. Epub 2020 Dec 24.

Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas.

Purpose: Microhematuria is a prevalent condition and the American Urological Association has developed a new risk-stratified approach for the evaluation of patients with microhematuria. Our objective was to provide the first evaluation of this important guideline.

Materials And Methods: This multinational cohort study combines contemporary patients from 5 clinical trials and 2 prospective registries who underwent urological evaluation for hematuria. Patients were stratified into American Urological Association risk strata (low, intermediate or high risk) based on sex, age, degree of hematuria, and smoking history. The primary end point was the incidence of bladder cancer within each risk stratum.

Results: A total of 15,779 patients were included in the analysis. Overall, 727 patients (4.6%) were classified as low risk, 1,863 patients (11.8%) were classified as intermediate risk, and 13,189 patients (83.6%) were classified as high risk. The predominance of high risk patients was consistent across all cohorts. A total of 857 bladder cancers were diagnosed with a bladder cancer incidence of 5.4%. Bladder cancer was more prevalent in men, smokers, older patients and patients with gross hematuria. The cancer incidence for low, intermediate and high risk groups was 0.4% (3 patients), 1.0% (18 patients) and 6.3% (836 patients), respectively.

Conclusions: The new risk stratification system separates hematuria patients into clinically meaningful categories with differing likelihoods of bladder cancer that would justify evaluating the low, intermediate and high risk groups with incremental intensity. Furthermore, it provides the relative incidence of bladder cancer in each risk group which should facilitate patient counseling regarding the risks and benefits of evaluation for bladder cancer.
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http://dx.doi.org/10.1097/JU.0000000000001550DOI Listing
May 2021

Patient-Reported Financial Toxicity Associated with Contemporary Treatment for Localized Prostate Cancer.

J Urol 2021 03 30;205(3):761-768. Epub 2020 Nov 30.

Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.

Purpose: Contemporary treatment modalities for localized prostate cancer provide comparable overall and cancer-specific survival. However, the degree of financial burden imposed by treatment, the factors contributing to that burden, and how different treatments compare with regard to financial toxicity remain poorly understood.

Materials And Methods: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study enrolled men with localized prostate cancer from 2011 to 2012. Questionnaires were collected at 6, 12, 36, and 60 months after enrollment. Differences in patient-reported financial burden were compared between active surveillance, radical prostatectomy, and external beam radiotherapy using multivariable logistic regression.

Results: Among 2,121 patients meeting inclusion criteria, 15% reported large or very large burden of treatment costs within 6 months, declining to 3% by year 5. When controlling for age, education, income and other covariates, external beam radiotherapy was associated with greater financial burden than active surveillance and radical prostatectomy at 1 year (OR 2.2, 95% CI 1.2-4.1 and OR 1.5, 95% CI 1.0-2.3, respectively) and 3 years (OR 3.1 95% CI 1.1-8.8 and OR 2.1, 95% CI 1.2-3.7, respectively). Radical prostatectomy and active surveillance had similar rates of financial burden at all time points. Age, race, education, and D'Amico risk group were associated with financial burden.

Conclusions: External beam radiotherapy was associated with the highest financial burden, even when controlling for age, education and income. Prospective studies that directly measure out-of-pocket and indirect costs and account more thoroughly for baseline socioeconomic differences are warranted in order to identify those most at risk.
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http://dx.doi.org/10.1097/JU.0000000000001423DOI Listing
March 2021

Neoadjuvant chemotherapy plus radical cystectomy versus radical cystectomy alone in clinical T2 bladder cancer without hydronephrosis.

BJU Int 2021 Jul 21;128(1):79-87. Epub 2020 Nov 21.

Division of Urology, Department of Surgical Sciences, Torino School of Medicine, Torino, Italy.

Objectives: To assess the efficacy of neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) in a retrospective multicentre cohort of patients with cT2N0M0 bladder cancer (BCa) without preoperative hydronephrosis.

Patients And Methods: This was a propensity-based analysis of 619 patients. Of these, 316 were treated with NAC followed by RC and 303 with upfront RC. After multiple imputations, inverse probability of treatment weighting (IPTW) was used to account for potential selection bias. Multivariable logistic regression analysis was performed to evaluate the impact of NAC on pathological complete response and downstaging at RC, while IPTW-adjusted Kaplan-Meier curves and Cox regression models were built to evaluate the impact of NAC on overall survival (OS).

Results: After IPTW-adjusted analysis, standardised differences between groups were <15%. A complete response (pT0N0) at final pathology was achieved in 94 (30%) patients receiving NAC and nine (3%) undergoing upfront RC. Downstaging to non-muscle-invasive disease (
Conclusions: In patients with cT2N0 BCa and no preoperative hydronephrosis, NAC increased the rate of pathological complete response and downstaging.
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http://dx.doi.org/10.1111/bju.15289DOI Listing
July 2021

Comparative effectiveness of neoadjuvant chemotherapy in bladder and upper urinary tract urothelial carcinoma.

BJU Int 2021 May 14;127(5):528-537. Epub 2020 Oct 14.

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.

Objective: To assess the differential response to neoadjuvant chemotherapy (NAC) in patients with urothelial carcinoma of the bladder (UCB) compared to upper tract urothelial carcioma (UTUC) treated with radical surgery.

Patients And Methods: Data from 1299 patients with UCB and 276 with UTUC were obtained from multicentric collaborations. The association of disease location (UCB vs UTUC) with pathological complete response (pCR, defined as a post-treatment pathological stage ypT0N0) and pathological objective response (pOR, defined as ypT0-Ta-Tis-T1N0) after NAC was evaluated using logistic regression analyses. The association with overall (OS) and cancer-specific survival (CSS) was evaluated using Cox regression analyses.

Results: A pCR was found in 250 (19.2%) patients with UCB and in 23 (8.3%) with UTUC (P < 0.01). A pOR was found in 523 (40.3%) patients with UCB and in 133 (48.2%) with UTUC (P = 0.02). On multivariable logistic regression analysis, patients with UTUC were less likely to have a pCR (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.27-0.70; P < 0.01) and more likely to have a pOR (OR 1.57, 95% CI 1.89-2.08; P < 0.01). On univariable Cox regression analyses, UTUC was associated with better OS (hazard ratio [HR] 0.80, 95% CI 0.64-0.99, P = 0.04) and CSS (HR 0.63, 95% CI 0.49-0.83; P < 0.01). On multivariable Cox regression analyses, UTUC remained associated with CSS (HR 0.61, 95% CI 0.45-0.82; P < 0.01), but not with OS.

Conclusions: Our present findings suggest that the benefit of NAC in UTUC is similar to that found in UCB. These data can be used as a benchmark to contextualise survival outcomes and plan future trial design with NAC in urothelial cancer.
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http://dx.doi.org/10.1111/bju.15253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246716PMC
May 2021

The Impact of Hospital Volume on Short-term and Long-term Outcomes for Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma.

Urology 2021 Jan 4;147:135-142. Epub 2020 Sep 4.

Department of Urology, Vanderbilt University Medical Center, Nashville, TN. Electronic address:

Objectives: To examine the effect of hospital volume on short and long-term outcomes for radical nephroureterectomy (RNUx). Upper tract urothelial carcinoma is a rare malignancy that few surgeons have experience with. The hospital volume-outcome relationship has been well established for other cancers but not RNUx.

Methods: The National Cancer Database was queried for all cases of upper tract urothelial carcinoma that underwent RNUx from 2004 to 2016. Average annual hospital volume for radical nephroureterectomy was stratified into tertiles. The upper tertile, defined as 6 or more RNUx per year, was considered high volume while low volume was less than 6 RNUx per year. Kaplan-Meier and Cox proportional hazards regression were used to identify independent predictors of overall survival, and logistic regression was used to identify predictors of perioperative outcomes.

Results: We identified 37,479 RNUx performed across 1290 hospitals. There were no differences in baseline health or cancer staging between patients who presented at low- versus high-volume centers. Both peri-operative survival (30- and 90-day mortality) and long-term overall survival were improved in patients treated at high-volume centers. On multivariable survival analysis, treatment at a high-volume center was associated with improved hazards of survival. This relationship for long-term survival remained consistent on landmark analysis where patients who died within 90 days of surgery were removed.

Conclusions: Treatment at a high-volume hospital was associated not only with improved short-term perioperative outcomes but also with improved overall long-term survival. The mechanism behind this is likely multifactorial with surgeon volume, and ancillary support services all playing critical roles.
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http://dx.doi.org/10.1016/j.urology.2020.07.062DOI Listing
January 2021

Radiotherapy after radical prostatectomy: Effect of timing of postprostatectomy radiation on functional outcomes.

Urol Oncol 2020 12 29;38(12):930.e23-930.e32. Epub 2020 Jul 29.

Department of Urology, Vanderbilt University Medical Center, Nashville, TN. Electronic address:

Introduction And Objective: The timing of radiotherapy (RT) after prostatectomy is controversial, and its effect on sexual, urinary, and bowel function is unknown. This study seeks to compare patient-reported functional outcomes after radical prostatectomy (RP) and postprostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function.

Methods: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study of men with localized prostate cancer. Patient-reported sexual, urinary, and bowel functional outcomes were measured using the 26-item Expanded Prostate Index Composite at baseline and at 6, 12, 36, and 60 months after enrollment. Functional outcomes were compared among men undergoing RP alone, post-RP adjuvant radiation (RP + aRT), and post-RP salvage radiation (RP + sRT) using multivariable models controlling for baseline clinical, demographic, and functional characteristics.

Results: Among 1,482 CEASAR participants initially treated with RP for clinically localized prostate cancer, 11.5% (N = 170) received adjuvant (aRT, N = 57) or salvage (sRT, N = 113) radiation. Men who received post-RP RT had worse scores in all domains (sexual function [-9.0, 95% confidence interval {-14.5, -3.6}, P < 0.001], incontinence [-8.8, {-14.0, -3.6}, P < 0.001], irritative voiding [-5.9, {-9.0, -2.8}, P < 0.001], bowel irritative [-3.5, {-5.8, -1.2}, P = 0.002], and hormonal function [-4.5, {-7.2, -1.7}, P = 0.001]) compared to RP alone at 5 years of follow-up. Compared to men treated with RP alone in an adjusted linear model, sRT was associated with significantly worse scores in all functional domains. aRT was associated with significantly worse incontinence, urinary irritation, and hormonal function domain scores compared to RP alone at 5 years of follow-up. On multivariable modeling, RT administered approximately 24 months after RP was associated with the smallest decline in sexual domain score, with an adjusted mean decrease of 8.85 points (95% confidence interval [-19.8, 2.1]) from post-RP, pre-RT baseline.

Conclusions: In men with localized prostate cancer, post-RP RT was associated with significantly worse sexual, urinary, and bowel function domain scores at 5 years compared to RP alone. Radiation delayed for approximately 24 months after RP may be optimal for preserving erectile function compared to radiation administered closer to the time of RP.
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http://dx.doi.org/10.1016/j.urolonc.2020.06.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8095316PMC
December 2020

Microhematuria: AUA/SUFU Guideline.

J Urol 2020 10 23;204(4):778-786. Epub 2020 Jul 23.

University of California, San Francisco, California.

Purpose: Patients presenting with microhematuria represent a heterogeneous population with a broad spectrum of risk for genitourinary malignancy. Recognizing that patient-specific characteristics modify the risk of underlying malignant etiologies, this guideline sought to provide a personalized diagnostic testing strategy.

Materials And Methods: The systematic review incorporated evidence published from January 2010 through February 2019, with an updated literature search to include studies published up to December 2019. Evidence-based statements were developed by the expert Panel, with statement type linked to evidence strength, level of certainty, and the Panel's judgment regarding the balance between benefits and risks/burdens.

Results: Microhematuria should be defined as ≥ 3 red blood cells per high power field on microscopic evaluation of a single specimen. In patients diagnosed with gynecologic or non-malignant genitourinary sources of microhematuria, clinicians should repeat urinalysis following resolution of the gynecologic or non-malignant genitourinary cause. The Panel created a risk classification system for patients with microhematuria, stratified as low-, intermediate-, or high-risk for genitourinary malignancy. Risk groups were based on factors including age, sex, smoking and other urothelial cancer risk factors, degree and persistence of microhematuria, as well as prior gross hematuria. Diagnostic evaluation with cystoscopy and upper tract imaging was recommended according to patient risk and involving shared decision-making. Statements also inform follow-up after a negative microhematuria evaluation.

Conclusions: Patients with microhematuria should be classified based on their risk of genitourinary malignancy and evaluated with a risk-based strategy. Future high-quality studies are required to improve the care of these patients.
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http://dx.doi.org/10.1097/JU.0000000000001297DOI Listing
October 2020

Assessing the Quality of Surgical Care for Clinically Localized Prostate Cancer: Results from the CEASAR Study.

J Urol 2020 12 22;204(6):1236-1241. Epub 2020 Jun 22.

Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.

Purpose: Prior studies suggest that nationally endorsed quality measures for prostate cancer care are not linked closely with outcomes. Using a prospective, population based cohort we measured clinically relevant variation in structure, process and outcome measures in men undergoing radical prostatectomy.

Materials And Methods: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) Study enrolled men with clinically localized prostate cancer diagnosed from 2011 to 2012 with 1,069 meeting the final inclusion criteria. Quality of life was assessed using the Expanded Prostate Index Composite (EPIC-26) and clinical data by chart review. Six quality measures were assessed, including pelvic lymphadenectomy with risk of lymph node involvement 2% or greater, appropriate nerve sparing, negative surgical margins, urinary and sexual function, treatment by high volume surgeon, and 30-day and 1-year complications. Receipt of high quality care was compared across categories of race, age, surgeon volume and surgical approach via multivariable analysis.

Results: There were no significant differences in quality across race, age or surgeon volume strata, except for worse urinary incontinence in Black men. However, robotic surgery patients experienced fewer complications (3% vs 9.3% short-term and 11% vs 16% long-term), were more likely to be treated by a high volume surgeon (47% vs 25%) and demonstrated better sexual function.

Conclusions: In this cohort we did not identify meaningful variation in quality of care across racial groups, age groups and surgeon volume strata, suggesting that men are receiving comparable quality of care across these strata. However, we did find variation between open and robotic surgery with fewer complications, improved sexual function and increased use of high volume surgeons in the robotic group, possibly reflecting differences in quality between approaches, differences in practice patterns and/or biases in patient selection.
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http://dx.doi.org/10.1097/JU.0000000000001198DOI Listing
December 2020

Comment on "Responsibilities and Expectations: Considerations of Disclosure of Overlapping Operations".

Ann Surg 2020 Jun 9. Epub 2020 Jun 9.

Department of Urology, Vanderbilt University Medical Center, Nashville, TN Department of Surgery, Division of Urology, Medical College of Georgia at Augusta University, Augusta, GA Georgia Cancer Center - Augusta University, Augusta, GA Department of Urology, Vanderbilt University Medical Center, Nashville, TN.

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http://dx.doi.org/10.1097/SLA.0000000000004016DOI Listing
June 2020

Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.

J Urol 2020 Sep 9;204(3):450-459. Epub 2020 Apr 9.

Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.

Purpose: We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer.

Materials And Methods: Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life.

Results: Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019).

Conclusions: Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.
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http://dx.doi.org/10.1097/JU.0000000000001029DOI Listing
September 2020

Development and Internal Validation of a Web-based Tool to Predict Sexual, Urinary, and Bowel Function Longitudinally After Radiation Therapy, Surgery, or Observation.

Eur Urol 2020 08 22;78(2):248-255. Epub 2020 Feb 22.

Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA.

Background: Shared decision making to guide treatment of localized prostate cancer requires delivery of the anticipated quality of life (QOL) outcomes of contemporary treatment options (including radical prostatectomy [RP], intensity-modulated radiation therapy [RT], and active surveillance [AS]). Predicting these QOL outcomes based on personalized features is necessary.

Objective: To create an easy-to-use tool to predict personalized sexual, urinary, bowel, and hormonal function outcomes after RP, RT, and AS.

Design, Setting, And Participants: A prospective, population-based cohort study was conducted utilizing US cancer registries of 2563 men diagnosed with localized prostate cancer in 2011-2012.

Intervention: Patient-reported urinary, sexual, and bowel function up to 5 yr after treatment.

Outcome Measurements And Statistical Analysis: Patient-reported urinary, sexual, bowel, and hormonal function through 5 yr after treatment were collected using the 26-item Expanded Prostate Index Composite (EPIC-26) questionnaire. Comprehensive models to predict domain scores were fit, which included age, race, D'Amico classification, body mass index, EPIC-26 baseline function, treatment, and standardized scores measuring comorbidity, general QOL, and psychosocial health. We reduced these models by removing the instrument scores and replacing D'Amico classification with prostate-specific antigen (PSA) and Gleason score. For the final model, we performed bootstrap internal validation to assess model calibration from which an easy-to-use web-based tool was developed.

Results And Limitations: The prediction models achieved bias-corrected R-squared values of 0.386, 0.232, 0.183, 0.214, and 0.309 for sexual function, urinary incontinence, urinary irritative, bowel, and hormonal domains, respectively. Differences in R-squared values between the comprehensive and parsimonious models were small in magnitude. Calibration was excellent. The web-based tool is available at https://statez.shinyapps.io/PCDSPred/.

Conclusions: Functional outcomes after treatment for localized prostate cancer can be predicted at the time of diagnosis based on age, race, PSA, biopsy grade, baseline function, and a general question regarding overall health. Providers and patients can use this prediction tool to inform shared decision making.

Patient Summary: In this report, we studied patient-reported sexual, urinary, hormonal, and bowel function through 5 yr after treatment with radical prostatectomy, radiation therapy, or active surveillance for localized prostate cancer. We developed a web-based predictive tool that can be used to predict one's outcomes after treatment based on age, race, prostate-specific antigen, biopsy grade, pretreatment baseline function, and a general question regarding overall health. We hope both patients and providers can use this tool to better understand expected outcomes after treatment, further enhancing shared decision making between providers and patients.
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http://dx.doi.org/10.1016/j.eururo.2020.02.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384934PMC
August 2020

Impact of sex on response to neoadjuvant chemotherapy in patients with bladder cancer.

Urol Oncol 2020 07 11;38(7):639.e1-639.e9. Epub 2020 Feb 11.

Department of Urology, The James Buchanan Brady Urological Institute, The Johns Hopkins School of Medicine, Baltimore, MD.

Objective: To assess the effect of patient's sex on response to neoadjuvant chemotherapy (NAC) in patients with clinically nonmetastatic muscle-invasive bladder cancer (MIBC).

Methods: Complete pathologic response, defined as ypT0N0 at radical cystectomy, and downstaging were evaluated using sex-adjusted univariable and multivariable logistic regression modeling. We used interaction terms to account for age of menopause and smoking status. The association of sex with overall survival and cancer-specific survival was evaluated using Cox regression analyses.

Results: A total of 1,031 patients were included in the analysis, 227 (22%) of whom were female. Female patients had a higher rate of extravesical disease extension (P = 0.01). After the administration of NAC, ypT stage was equally distributed between sexes (P = 0.39). On multivariable logistic regression analyses, there was no difference between the sexes or age of menopause with regards to ypT0N0 rates or downstaging (all P > 0.5). On Cox regression analyses, sex was associated with neither overall survival (hazard ratio 1.04, 95% confidence interval 0.75-1.45, P = 0.81) nor cancer-specific survival (hazard ratio 1.06, 95% confidence interval 0.71-1.58, P = 0.77).

Conclusion: Our study generates the hypothesis that NAC equalizes the preoperative disparity in pathologic stage between males and females suggesting a possible differential response between sexes. This might be the explanation underlying the comparable survival outcomes between sexes despite females presenting with more advanced tumor stage.
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http://dx.doi.org/10.1016/j.urolonc.2020.01.010DOI Listing
July 2020

Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer.

JAMA 2020 01;323(2):149-163

Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.

Importance: Understanding adverse effects of contemporary treatment approaches for men with favorable-risk and unfavorable-risk localized prostate cancer could inform treatment selection.

Objective: To compare functional outcomes associated with prostate cancer treatments over 5 years after treatment.

Design, Setting, And Participants: Prospective, population-based cohort study of 1386 men with favorable-risk (clinical stage cT1 to cT2bN0M0, prostate-specific antigen [PSA] ≤20 ng/mL, and Grade Group 1-2) prostate cancer and 619 men with unfavorable-risk (clinical stage cT2cN0M0, PSA of 20-50 ng/mL, or Grade Group 3-5) prostate cancer diagnosed in 2011 through 2012, accrued from 5 Surveillance, Epidemiology and End Results Program sites and a US prostate cancer registry, with surveys through September 2017.

Exposures: Treatment with active surveillance (n = 363), nerve-sparing prostatectomy (n = 675), external beam radiation therapy (EBRT; n = 261), or low-dose-rate brachytherapy (n = 87) for men with favorable-risk disease and treatment with prostatectomy (n = 402) or EBRT with androgen deprivation therapy (n = 217) for men with unfavorable-risk disease.

Main Outcomes And Measures: Patient-reported function, based on the 26-item Expanded Prostate Index Composite (range, 0-100), 5 years after treatment. Regression models were adjusted for baseline function and patient and tumor characteristics. Minimum clinically important difference was 10 to 12 for sexual function, 6 to 9 for urinary incontinence, 5 to 7 for urinary irritative symptoms, and 4 to 6 for bowel and hormonal function.

Results: A total of 2005 men met inclusion criteria and completed the baseline and at least 1 postbaseline survey (median [interquartile range] age, 64 [59-70] years; 1529 of 1993 participants [77%] were non-Hispanic white). For men with favorable-risk prostate cancer, nerve-sparing prostatectomy was associated with worse urinary incontinence at 5 years (adjusted mean difference, -10.9 [95% CI, -14.2 to -7.6]) and sexual function at 3 years (adjusted mean difference, -15.2 [95% CI, -18.8 to -11.5]) compared with active surveillance. Low-dose-rate brachytherapy was associated with worse urinary irritative (adjusted mean difference, -7.0 [95% CI, -10.1 to -3.9]), sexual (adjusted mean difference, -10.1 [95% CI, -14.6 to -5.7]), and bowel (adjusted mean difference, -5.0 [95% CI, -7.6 to -2.4]) function at 1 year compared with active surveillance. EBRT was associated with urinary, sexual, and bowel function changes not clinically different from active surveillance at any time point through 5 years. For men with unfavorable-risk disease, EBRT with ADT was associated with lower hormonal function at 6 months (adjusted mean difference, -5.3 [95% CI, -8.2 to -2.4]) and bowel function at 1 year (adjusted mean difference, -4.1 [95% CI, -6.3 to -1.9]), but better sexual function at 5 years (adjusted mean difference, 12.5 [95% CI, 6.2-18.7]) and incontinence at each time point through 5 years (adjusted mean difference, 23.2 [95% CI, 17.7-28.7]), than prostatectomy.

Conclusions And Relevance: In this cohort of men with localized prostate cancer, most functional differences associated with contemporary management options attenuated by 5 years. However, men undergoing prostatectomy reported clinically meaningful worse incontinence through 5 years compared with all other options, and men undergoing prostatectomy for unfavorable-risk disease reported worse sexual function at 5 years compared with men who underwent EBRT with ADT.
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http://dx.doi.org/10.1001/jama.2019.20675DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990712PMC
January 2020

Microscopic Hematuria: Diagnosis Is Only Half the Battle.

Eur Urol 2020 05 20;77(5):599-600. Epub 2019 Dec 20.

Department of Urology, Mayo Clinic, Rochester, MN, USA. Electronic address:

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http://dx.doi.org/10.1016/j.eururo.2019.12.011DOI Listing
May 2020

The prognostic value of the neutrophil-to-lymphocyte ratio in patients with muscle-invasive bladder cancer treated with neoadjuvant chemotherapy and radical cystectomy.

Urol Oncol 2020 01 31;38(1):3.e17-3.e27. Epub 2019 Oct 31.

Cross Cancer Institute, Edmonton, AB, Canada; Department of Oncology, University of Alberta, AB, Canada.

Introduction: The neutrophil-to-lymphocyte ratio (NLR) is an attractive marker because it is derived from routine bloodwork. NLR has shown promise as a prognostic factor in muscle invasive bladder cancer (MIBC) but its value in patients receiving neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) is not yet established. Since NLR is related to an oncogenic environment and poor antitumor host response, we hypothesized that a high NLR would be associated with a poor response to NAC and would remain a poor prognostic indicator in patients receiving NAC.

Methods: A retrospective analysis was performed on patients with nonmetastatic MIBC (cT2-4aN0M0) who received NAC prior to RC between 2000 and 2013 at 1 of 19 centers across Europe and North America. The pre-NAC NLR was used to split patients into a low (NLR ≤ 3) and high (NLR > 3) group. Demographic and clinical parameters were compared between the groups using Student's t test, chi-squared, or Fisher's exact test. Putative risk factors for disease-specific and overall survival were analyzed using Cox regression, while predictors of response to NAC (defined as absence of MIBC in RC specimen) were investigated using logistic regression.

Results: Data were available for 340 patients (199 NLR ≤ 3, 141 NLR > 3). Other than age and rate of lymphovascular invasion, demographic and pretreatment characteristics did not differ significantly. More patients in the NLR > 3 group had residual MIBC after NAC than the NLR ≤ 3 group (70.8% vs. 58.3%, P = 0.049). NLR was the only significant predictor of response (odds ratio: 0.36, P = 0.003) in logistic regression. NLR was a significant risk factor for both disease-specific (hazard ratio (HR): 2.4, P = 0.006) and overall survival (HR:1.8, P = 0.02).

Conclusion: NLR > 3 was associated with a decreased response to NAC and shorter disease-specific and overall survival. This suggests that NLR is a simple tool that can aid in MIBC risk stratification in clinical practice.
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http://dx.doi.org/10.1016/j.urolonc.2019.09.023DOI Listing
January 2020

Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup.

J Urol 2020 03 24;203(3):522-529. Epub 2019 Sep 24.

Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.

Purpose: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival.

Materials And Methods: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis.

Results: Estimated progression-free survival at 36 months was 68.4% (95% CI 60.1-75.3) and 65.4% (95% CI 56.8-72.7) in the robotic and open groups, respectively (p=0.600). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome.

Conclusions: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.
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http://dx.doi.org/10.1097/JU.0000000000000565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487279PMC
March 2020

Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes?

J Urol 2019 12 19;202(6):1150-1158. Epub 2019 Jun 19.

Department of Urology, Patient Advocacy Program, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.

Purpose: The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question.

Materials And Methods: Using data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result.

Results: For every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80.

Conclusions: Our findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.
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http://dx.doi.org/10.1097/JU.0000000000000392DOI Listing
December 2019

The Harms of Hematuria Evaluation: Modeling the Risk-Benefit of Using Split Bolus Computerized Tomography Urography to Reduce Radiation Exposure in a Theoretical Cohort.

J Urol 2019 11 9;202(5):899-904. Epub 2019 Oct 9.

Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.

Purpose: Computerized tomography urography is used to evaluate patients with gross or microscopic hematuria. Computerized tomography urography is a high radiation dose scan and, thus, it confers a higher risk of secondary malignancy. A computerized tomography urography split bolus protocol reduces radiation exposure but it may reduce sensitivity. In this study we used a theoretical cohort of patients with hematuria in which to model the risk of missing malignancies against the benefit of averting secondary malignancies.

Materials And Methods: We calculated the prevalence of renal cell carcinoma and upper tract urothelial carcinoma in patients with hematuria by pooled analysis of cohort studies, which in conjunction with split bolus sensitivity allows for the estimation of missed malignancies. The number of prevented secondary malignancies was calculated from lifetime attributable risk estimates. Sensitivity analyses were run to determine the minimum sensitivity required for a net population benefit.

Results: Estimates of split bolus computerized tomography urography sensitivity ranged from 80% to 100% (mean 95.2%). At the low estimate of 80% sensitivity split bolus computerized tomography urography was beneficial in men and women with microscopic hematuria at ages less than 50 and less than 60 years, respectively. An increase in sensitivity to 90% improved the benefit 1 decade in each gender, representing 68.8% of patients with microscopic hematuria. The overall population of patients with microscopic hematuria benefited from split bolus computerized tomography urography at 91.1% sensitivity. However, in patients with gross hematuria the threshold for an overall population benefit was high at 98.4% sensitivity.

Conclusions: Exposure to ionizing radiation risks causing secondary malignancy. These data indicate that split bolus computerized tomography urography may be performed safely in 70% of the population of patients with microscopic hematuria. However, it is not currently advisable in patients with gross hematuria or in other patients at high risk.
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http://dx.doi.org/10.1097/JU.0000000000000387DOI Listing
November 2019

Cost-Effectiveness of Active Surveillance, Radical Prostatectomy and External Beam Radiotherapy for Localized Prostate Cancer: An Analysis of the ProtecT Trial.

J Urol 2019 11 9;202(5):964-972. Epub 2019 Oct 9.

Department of Urology, Mayo Clinic, Rochester, Minnesota.

Purpose: Despite increasing emphasis on value based care, to our knowledge the cost-effectiveness of prostate cancer management options has not been compared using prospective clinical trial data. The ProtecT (Prostate Testing for Cancer and Treatment) trial demonstrated no difference in survival in patients randomized to active surveillance, external beam radiotherapy or radical prostatectomy. We compared cost-effectiveness among the arms of ProtecT.

Materials And Methods: Using a Markov model we compared the cost-effectiveness of active surveillance, radical prostatectomy and external beam radiotherapy based on ProtecT outcomes, specifically 6-year quality of life data and 10-year oncologic data. Costs were based on 2017 Medicare reimbursement while utility values were assigned using the literature. Univariable and multivariable sensitivity analyses were performed.

Results: Six years after randomization the mean costs per patient were $12,143 for active surveillance, $17,781 for radical prostatectomy and $29,238 for external beam radiotherapy. The incremental cost-effectiveness ratio relative to active surveillance was $127,752/QALY for radical prostatectomy and $381,894/QALY for external beam radiotherapy. Ten years after randomization radical prostatectomy ($5,627/QALY) and external beam radiotherapy ($78,291/QALY) were more cost-effective than active surveillance. The model was sensitive to the metastasis rate on active surveillance with a threshold of 2.4% at 10 years, below which active surveillance was more cost-effective than radical prostatectomy. On multivariable sensitivity analysis at 10 years using a willingness to pay threshold of $100,000/QALY the most cost-effective strategy was radical prostatectomy in 45% of model microsimulations, external beam radiotherapy in 30% and active surveillance in 25%.

Conclusions: Although active surveillance represents a cost-effective strategy to manage localized prostate cancer during the initial several years after diagnosis, the relative cost-effectiveness of treatment emerges with extended followup.
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http://dx.doi.org/10.1097/JU.0000000000000345DOI Listing
November 2019

Staging the Host: Personalizing Risk Assessment for Radical Cystectomy Patients.

Eur Urol Oncol 2018 09 19;1(4):292-304. Epub 2018 Jun 19.

Department of Urology, Mayo Clinic, Rochester, MN, USA.

Context: Perioperative and long-term functional and oncologic outcomes following radical cystectomy (RC) for localized bladder cancer remain unchanged despite advances in technique and perioperative management, as well as neoadjuvant and adjuvant therapy. Accurate assessment of a patient's perioperative risk is critical to inform preoperative counseling and determine a patient's fitness for RC.

Objective: To review and synthesize conventional and novel objective patient-specific risk assessment tools that may be incorporated into clinical practice for perioperative risk prognostication with respect to both postoperative complications and long-term oncologic outcomes, patient counseling, and decision-making when RC is being considered.

Evidence Acquisition: A collaborative review was performed to synthesize currently available evidence on comorbidity, age, body composition, nutrition, frailty, and geriatric assessments for patients undergoing RC.

Evidence Synthesis: Current guidelines recommend that pre-RC risk assessment should take into account age, performance status, and comorbidity. However, conventional comorbidity indices perform inconsistently in accurate assessment of the risk of perioperative complications, prolonged rehabilitation, and long-term oncologic outcomes. Novel metrics including standardized assessments of dependency, comorbidity severity, sarcopenia, malnutrition, physical and cognitive frailty, and comprehensive geriatric assessments may offer more precise estimates of physiologic age and relative vulnerability to adverse outcomes following RC.

Conclusions: Perioperative risk assessment before RC should incorporate objective measures of physiologic age, physical function, nutrition, lean muscularity, and frailty. The use of standardized multidimensional instruments should be encouraged for patients undergoing consideration for RC to identify potentially modifiable risk factors that can be targeted with prehabilitation interventions. Future work is needed to validate the performance of these metrics with respect to predicting perioperative complications and oncologic outcomes and to define and assess the effectiveness of specific prehabilitation interventions to optimize patients before surgery.

Patient Summary: We review several metrics that doctors can use to measure the risks associated with bladder removal, a major surgical procedure. Moving beyond evaluating a patient's age, the burden of other health problems, and surgeon intuition, these tools may be used to counsel patients regarding their surgical risk, to predict oncologic outcomes, and to help identify potential interventions to improve surgical readiness.
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http://dx.doi.org/10.1016/j.euo.2018.05.010DOI Listing
September 2018

Functional Recovery Following Primary Treatment for Prostate Cancer: Update from the CEASAR Study.

Eur Urol Focus 2020 03 7;6(2):205-207. Epub 2019 May 7.

Vanderbilt University Medical Center, Nashville, TN, USA.

The CEASAR study uses patient-reported outcomes to provide actionable quality-of-life data for shared-decision making for patients with localized prostate cancer.
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http://dx.doi.org/10.1016/j.euf.2019.04.001DOI Listing
March 2020

Contemporary prostate cancer radiation therapy in the United States: Patterns of care and compliance with quality measures.

Pract Radiat Oncol 2018 Sep - Oct;8(5):307-316

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Purpose: Quality measures represent the standards of appropriate treatment agreed upon by experts in the field and often supported by data. The extent to which providers in the community adhere to quality measures in radiation therapy (RT) is unknown.

Methods And Materials: The Comparative Effectiveness Analysis of Surgery and Radiation study enrolled men with clinically localized prostate cancer in 2011 and 2012. Patients completed surveys and medical records were reviewed. Patients were risk-stratified according to D'Amico classification criteria. Patterns of care and compliance with 8 quality measures as endorsed by national consortia as of 2011 were assessed.

Results: Overall, 926 men underwent definitive RT (69% external beam radiation therapy [EBRT]), 17% brachytherapy (BT), and 14% combined EBRT and BT with considerable variation in radiation techniques across risk groups. Most men who received EBRT had dose-escalated EBRT (>75 Gy; 93%) delivered with conventional fractionation (<2 Gy; 95%), intensity modulated RT (76%), and image guided RT (85%). Most men treated with BT received I125 (77%). Overall, 73% of the men received EBRT that was compliant with the quality measures (dose-escalation, image-guidance, appropriate use of androgen deprivation therapy, and appropriate treatment target) but only 60% of men received BT that was compliant with quality measures (postimplant dosimetry and appropriate dose). African-American men (64%) and other minorities (62%) were less likely than white men (77%) to receive EBRT that was compliant with quality measures.

Conclusions: Most men who received RT for localized prostate cancer were treated with an appropriately high dose and received image guidance and intensity modulated RT. However, compliance with some nationally recognized quality measures was relatively low and varied by race. There are significant opportunities to improve the delivery of RT and especially for men of a minority race.
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http://dx.doi.org/10.1016/j.prro.2018.04.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492101PMC
November 2018

Comparison of Patient-reported Outcomes After External Beam Radiation Therapy and Combined External Beam With Low-dose-rate Brachytherapy Boost in Men With Localized Prostate Cancer.

Int J Radiat Oncol Biol Phys 2018 09 1;102(1):116-126. Epub 2018 Jun 1.

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Purpose: To compare patient-reported disease-specific functional outcomes after external beam radiation therapy (EBRT) and EBRT combined with low-dose-rate brachytherapy prostate boost (EB-LDR) among men with localized prostate cancer.

Methods And Materials: The prospective, population-based Comparative Effectiveness Analysis of Surgery and Radiation study enrolled men with localized prostate cancer in 2011 to 2012. The 26-item Expanded Prostate Cancer Index Composite measured patient-reported disease-specific function at baseline and at 6, 12, and 36 months. Higher domain scores indicate better function. Minimal clinically important difference was defined as 6 for urinary incontinence, 5 for urinary irritative function, 4 for bowel function, 12 for sexual function, and 4 for hormonal function. Multivariable linear and logistic regression models were fit to estimate the effect of treatment on patient-reported outcomes.

Results: Five-hundred seventy-eight men received EBRT and 109 received EB-LDR. Median patient age was 69 years, and 70% had intermediate- or high-risk disease. Men in the EB-LDR group were younger (P < .001) and less likely to receive androgen deprivation therapy (P < .001). Baseline urinary, bowel, sexual, and hormonal function was similar between treatment groups (P > .05). On multivariable analyses, men receiving EB-LDR reported worse urinary irritative function at 6 months (adjusted mean difference [AMD] -14.4, P < .001), 12 months (AMD -12.9, P < .001), and 36 months (AMD -4.7, P = .034) than men receiving EBRT. At 12 months, men receiving EB-LDR reported worse bowel function (AMD -5.8, P = .002), but these differences were not seen at 36 months. There were no significant differences in sexual or hormone function between treatment groups.

Conclusions: Men treated with EB-LDR report worse bowel function at 1 year and worse urinary irritative function through 3 years compared with men treated with EBRT alone. These side effect profiles should be discussed with patients when considering EB-LDR versus EBRT treatment.
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http://dx.doi.org/10.1016/j.ijrobp.2018.05.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492102PMC
September 2018

Racial variation in receipt of quality radiation therapy for prostate cancer.

Cancer Causes Control 2018 Oct 11;29(10):895-899. Epub 2018 Aug 11.

Department of Radiation Oncology, MD Anderson Cancer Center, Houston, TX, USA.

Purpose: Racial disparities are apparent in the management and outcomes for prostate cancer; however, disparities in compliance to quality measures for radiation therapy for prostate cancer have not been previously studied. Therefore, the goal of the study was to characterize disparities in the compliance rates with quality measures.

Methods: The comparative effectiveness analysis of radiation therapy and surgery study is a population-based, prospective cohort study that enrolled 3708 men with clinically localized prostate cancer from 2011 to 2012. Compliance with 5 radiation-specific quality measures endorsed by national consortia as of 2011 was assessed, and compliance was compared by race using logistic regression.

Results: Overall, 604 men received definitive external beam radiation therapy (EBRT) of which 20% were self-reported black, 74% non-Hispanic white, and 6% Hispanic. Less than two-thirds of black and Hispanic men received EBRT that was compliant with all available quality measures (p = 0.012). Compared to white men, black men were less likely to receive dose-escalated EBRT (95% vs. 87%, p = 0.011) and less likely to avoid unnecessary pelvic radiation for low-risk disease (99% vs. 20%, p < 0.001). Compared to white men, Hispanic men were less likely to undergo image guidance (87% vs. 71%, p = 0.04). Black and Hispanic men were more likely to receive EBRT from low-quality providers than white men.

Conclusions: Addressing disparities in access to providers that meet quality guidelines, and improving adherence to evidence-based processes of care may decrease racial/ethnic disparities in prostate cancer outcomes.
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http://dx.doi.org/10.1007/s10552-018-1065-5DOI Listing
October 2018
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