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Prostate-Specific Antigen Levels Among Participants Receiving Annual Testing
Pickersgill, Nicholas A; Peré, Maria M; Vertosick, Emily A; Nalavenkata, Sunny; Vieira Lima Aguiar Melão, Bárbara; Vickers, Andrew J; Lilja, Hans; Eastham, James A; Carlsson, Sigrid V
IMPORTANCE/UNASSIGNED:Repeating a prostate-specific antigen (PSA) test after an elevated measurement is a guideline-recommended component of the prebiopsy workup. However, it is unclear whether certain patients can be exempted from repeat PSA testing and proceed directly to further workup. OBJECTIVE/UNASSIGNED:To determine yearly PSA variability and implications of repeating an elevated PSA in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This retrospective multicenter cohort study used data from men aged 54 to 75 years participating in the screening arm of the randomized PLCO trial who received PSA testing annually over 6 years (between 1995 and 2006) without a prostate cancer diagnosis. Data were analyzed from February 10, 2023, to May 23, 2025. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was the proportion of PSA measurements above 1 of the 3 biopsy thresholds of interest (2.5, 3.0, and 4.0 ng/mL) that decreased below the threshold at the subsequent yearly measurement. Analyses were conducted at both the PSA test and patient levels. RESULTS/UNASSIGNED:Among 11 176 eligible patients (median age 60 years, IQR, 57-65 years), 2700 patients were included at a threshold of 2.5 ng/mL, 1928 patients at 3.0 ng/mL, and 952 patients at 4.0 ng/mL at least once. Among PSA measurements greater than or equal to 2.5 ng/mL, 22% (95% CI, 21%-23%) decreased below 2.5 ng/mL the following year; rates were similar for thresholds of 3.0 ng/mL and 4.0 ng/mL. At the patient level, 54% (95% CI, 53%-56%) of men with at least 1 PSA greater than or equal to 2.5 ng/mL had a subsequent level below this threshold, with slightly greater rates for the higher thresholds. A predictive scoring system incorporating current and prior PSA levels showed that patients with PSA levels persistently above thresholds had a low (<10%) probability of PSA decreasing below the threshold. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this study, significant intra-individual variability in PSA levels was observed in this large screening cohort, with many elevated values falling below the threshold at the next yearly measurement. These findings suggest the utility of guideline recommendations to confirm elevated PSA results in most patients before performing further diagnostic evaluation and that patients with a prior PSA score above a given biopsy threshold, and no recent PSA scores below that threshold, could proceed to further diagnostic evaluation without repeat testing.
PMCID:12447284
PMID: 40965920
ISSN: 2374-2445
CID: 5954012
Rizedisben in Minimally Invasive Surgery: A Nonrandomized Clinical Trial [Comment]
Gold, Samuel A; Pere, Maria M; Assel, Melissa; Doudt, Alexander D; Durdin, Trey D; Silagy, Andrew W; Dean, Lucas W; Recabal, Pedro; Levine, Erica; Burke, Alan; Ragupathi, Govind; Marzabadi, Mohammad R; Yao, Zhong-Ke; Yang, Guangbin; Yang, Guangli; Ouerfelli, Ouathek; McCarter, Melissa; Chen, Xi; Tzatha, Efstathia; Coleman, Jonathan A; Goh, Alvin C; Smith, Robert C; Ehdaie, Behfar; Vickers, Andrew J; Scardino, Peter T; Eastham, James A; Laudone, Vincent P; Donahue, Timothy F
IMPORTANCE/UNASSIGNED:Fluorescence-guided surgery aims to improve intraoperative identification of vital structures. Rizedisben is a myelin-binding fluorophore that fluoresces in the blue light (370-425 nm) spectrum to improve intraoperative nerve identification. OBJECTIVE/UNASSIGNED:To determine the optimal safe and clinically effective dose of rizedisben for sustained intraoperative fluorescence of nerve structures. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:A single-arm, open-label, phase 1 study was conducted in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP) at an urban academic cancer center in New York City between January 2023 and October 2024. Using a dose escalation design, increasing doses of rizedisben were administered after safety was assessed at each level until a clinically effective dose was determined. The obturator nerve served as the reference nerve for measuring fluorescence intensity. Eligible patients were 18 years old and older, diagnosed with prostate cancer, and scheduled for RALP. Patients were recruited in preoperative clinic visits once deemed eligible for the study. Those with prior pelvic surgery or radiation, known central or peripheral nervous system disease, current use of neurotoxic medications, recent exposure to phototoxic drugs, or serious kidney or liver dysfunction were excluded. INTERVENTIONS/UNASSIGNED:Rizedisben was intravenously administered intraoperatively 30 minutes prior to visualization of the obturator nerve. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Safety was assessed through 45 postoperative days. Fluorescence was measured via subjective intraoperative scoring and by post hoc objective image analysis. Clinically effective dose was defined as achieving sustained fluorescence of the obturator nerve in 3 or more of 5 patients in 2 consecutive cohorts, provided fewer than 20% of patients experienced grade 2 or greater toxicity. Sustained fluorescence was defined as moderate or better fluorescence for 90 minutes or longer. At the clinically effective dose, fluorescence assessments of the neurovascular bundles were included. RESULTS/UNASSIGNED:Thirty-eight patients (median [IQR] age, 61.5 [57.8-66.3] years) enrolled in and completed the trial. Dosing was escalated from 0.25 to 3.0 mg/kg. There was 1 grade 2 adverse event (rash) possibly attributable to rizedisben. Sustained fluorescence of the obturator nerve was achieved in all patients at 3.0 mg/kg. Prostate neurovascular bundles demonstrated evidence of fluorescence in 8 of 9 (89%) patients at 3.0 mg/kg. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this phase 1 trial of rizedisben, the 3.0-mg/kg dose was shown to be generally well tolerated and clinically effective. At this dose, there was excellent sustained fluorescence of the obturator nerves, and the neurovascular bundles were visualized in 8 of 9 patients. Based on these data, we are designing phase 2 studies with rizedisben for additional indications. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04983862.
PMID: 40601345
ISSN: 2168-6262
CID: 5954002
Association of health care policy and trends in cancer screening during the COVID-19 pandemic
Pelzman, Daniel L; Sharbaugh, Danielle; Yabes, Jonathan G; Lin, Jonathan; Pere, Maria; Vajravelu, Ravy; Wilson, David; Zuley, Margarita; Taylor, Sarah; Davies, Benjamin J; Sabik, Lindsay M; Jacobs, Bruce L
INTRODUCTION/BACKGROUND:Cancer screening trends and associations with statewide containment policies during the COVID-19 pandemic are not fully understood. We sought to examine trends in screening rates for prostate, breast, cervical, colon, and lung cancer from March to December 2020, and to examine whether statewide containment policies were associated with screening rates. METHODS:We performed a retrospective cohort studying using the Healthjump dataset, which comprises encounter-level data for more than 40 million patients across the United States. Individuals with at least one cancer screening test between 1/2016 and 12/2020 were included. Expected screenings during the pandemic were calculated using a seasonally-adjusted model and compared with observed values. The association with containment policies was estimated by comparing these ratios to statewide stringency indices measured by the Oxford COVID-19 Government Response Tracker. RESULTS:There was a negative, significant association between statewide stringency policies and observed-to-expected screening ratios for all cancers. In addition, there was a rapid decrease in the observed-to-expected screening ratios for all cancers in April 2020 followed by a rise in screening for all cancers in the latter half of 2020. Prostate, cervical, colon, and lung cancer screening increased beyond expected counts, while breast cancer screening approached expected counts. CONCLUSIONS:More stringent statewide containment policies were negatively associated with screening rates. These rates decreased during the early phase of the COVID-19 pandemic, but subsequently increased to normal or near-normal.
PMID: 40460779
ISSN: 1877-783x
CID: 5953992
Assessment of postoperative practices and discharge recommendations after radical prostatectomy
Melão, Bárbara Vieira Lima Aguiar; Assel, Melissa; Pere, Maria; Nalavenkata, Sunny; Touijer, Karim A; Laudone, Vincent P; Lin, Daniel W; Rivas, Juan Gomez; Bjartell, Anders; Carlsson, Sigrid V
PURPOSE:Consistent, accurate postoperative guidance is crucial for early recovery and patient satisfaction in urology, especially for radical prostatectomy (RP) patients. However, patients often receive inconsistent information, highlighting the need for standardized, evidence-based postoperative care guidelines. MATERIALS AND METHODS:We conducted a comprehensive review and evaluation of current postoperative practices for RP. This involved (1) reviewing existing discharge information at Josie Robertson Surgery Center, Memorial Sloan Kettering Cancer Center to identify areas of improvement; (2) systematically evaluating inconsistencies in discharge instructions and their impact on patient care; (3) distributing an anonymous survey to urologists in the US and Europe via REDCap to gather insights into global postoperative care practices. The survey included questions on various aspects of postoperative care, such as catheter use, medication regimens, dietary restrictions, and physical activity guidelines. RESULTS:We received 247 survey responses. Despite some consensus on certain postoperative practices and recommendations, significant variability existed, underscoring the lack of standardized guidelines. Notable differences were observed between US and European cohorts, particularly in postoperative length of stay and discharge practices. Only 1.4% of US responders discharged patients 3 or more days postsurgery compared to 46% in Europe. Variability was also noted in recommendations for erectile function medications and postoperative activity restrictions. CONCLUSION:This study underscores the significant variability in postoperative care recommendations for RP and the urgent need for standardized, evidence-based guidelines. Implementing such guidelines will enhance patient recovery, satisfaction, and overall outcomes, improving postoperative care across various surgical procedures.
PMCID:12255528
PMID: 40307080
ISSN: 1873-2496
CID: 5954022
Factors influencing readmission patterns following radical cystectomy: An analysis of social determinants and discharge outcomes
Grajales, Valentina; Lin, Jonathan Y; Sharbaugh, Danielle; Pere, Maria; Sharbaugh, Adam; Miller, David T; Pelzman, Dan; Sun, ZhaoJun; Eom, Kirsten Y; Davies, Benjamin J; Yabes, Jonathan G; Sabik, Lindsay M; Jacobs, Bruce L
INTRODUCTION AND OBJECTIVES:Radical cystectomy readmission rates remain high, with around 25% of patients readmitted to index and nonindex hospitals in 30 days. Nonindex readmissions have been associated with poorer outcomes, including longer lengths of stay and higher mortality rates. This study aimed to examine the associations of social factors (e.g., sex, race, socioeconomic status, insurance type, and resident location) on readmission to index versus nonindex hospitals and discharge disposition. METHODS:We conducted a population-based retrospective study using the Pennsylvania Cancer Registry (PCR) to identify patients diagnosed with nonmetastatic muscle-invasive bladder cancer who underwent radical cystectomy in Pennsylvania between 2010 and 2018. Readmitted patients were identified using the Pennsylvania Health Care Cost Containment Council data (PHC4). The primary outcome was readmission location (i.e., index or nonindex hospital) following radical cystectomy. We used chi-square tests for categorical variables, Wilcoxon rank sum test for continuous variables, multivariable logistic regression model to assess predictors of being readmitted to an index hospital and calculating the predicted probability of being admitted to an index hospital depending on discharge disposition. RESULTS:A total of 517 patients were readmitted within 30-days after radical cystectomy. The majority of readmissions were index readmissions (83%). Median readmission hospital stay was 4 days (interquartile range [IQR] 4) for index and 5 days (IQR 7) for nonindex hospitals, P = 0.01. Patients readmitted to index hospitals had fewer comorbidities (median weighted Elixhauser Comorbidity Index 2 (IQR 2)) and lived in urban areas (89%). Discharge with home care was associated with a higher odds of index readmission (odds ratio, [OR] 2.40; 95% confidence interval, [CI] 1.25-4.52). CONCLUSIONS:Patients residing in urban areas and with fewer comorbidities were more likely to be readmitted to index hospitals than nonindex hospitals. Socioeconomic status and insurance type did not correlate with the type of readmission. Finally, being discharged with home health care was found to be a predictor of readmission to an index hospital.
PMCID:11583962
PMID: 39153890
ISSN: 1873-2496
CID: 5944822
A Multipronged Intervention to Reduce Readmissions and Readmission Intensity After Radical Cystectomy
Gul, Zeynep G; Wu, Shan; Raver, Michael; Vasan, Robin; Mihalo, Jennifer; Myrga, John M; Miller, David T; Pere, Maria P; Jones, Cameron A; Sharbaugh, Danielle R; Yabes, Jonathan G; Jacobs, Bruce L; Davies, Benjamin J
OBJECTIVE:To develop a multipronged, evidence-based protocol to reduce readmission risk and readmission intensity, as represented by the duration of the index readmission, after radical cystectomy. MATERIALS AND METHODS:A per-protocol study was performed. The protocol included preoperative nutritional supplementation, early stent removal, and a follow-up phone call within 4-5days of discharge. The preprotocol period was from February 1, 2020 to July 31, 2021 and the postprotocol period was from December 1, 2020 to November 31, 2021. Using multivariate regression models, we compared outcomes among patients treated with radical cystectomy before and after protocol initiation. RESULTS:We identified 70 preprotocol patients and 126 postprotocol patients. After adjusting for age, sex, BMI, and frailty score, there was a significant reduction in 90-day readmission intensity (7 vs 5days; P = .048) among postprotocol patients. CONCLUSION:After implementation of an evidence-based protocol for patients undergoing radical 90-day readmission intensity decreased significantly. This protocol may move the needle forward on reducing readmissions, but a larger randomized trial is needed.
PMID: 37666330
ISSN: 1527-9995
CID: 5944812
Discharge Opioids are Unnecessary Following Radical Cystectomy
Myrga, J M; Wu, S; Gul, Z G; Yu, M; Sharbaugh, D R; Mihalo, J; Patnaik, S; Vasan, R V; Miller, D T; Pere, M P; Yabes, J G; Jacobs, B L; Davies, B J
OBJECTIVE:To show that zero-opioid discharges after both open and robotic cystectomy are feasible and to examine the impact of zero-opioid discharges on patient interaction with the physician's office. MATERIALS AND METHODS:One hundred seven patients who underwent either open or robotic radical cystectomy from March 1, 2020 to December 30, 2020 were identified. Patient demographics, perioperative data, and 30 day pain related outcomes including phone calls, office visits, requests for pain medication, emergency department visits, and readmissions were abstracted from the chart. We then examined variables associated with a zero-opioid discharge. RESULTS:Thirty-two patients were discharged with an opioid prescription (Median Oral Morphine Equivalents Prescribed = 90) and 75 were discharged without an opioid prescription. On regression analysis, age (OR 1.07, 95% CI [1.02-1.12]) and pathology (OR 0.36, 95% CI[0.14-0.9]) remained significantly associated with post-operative opioid prescriptions. There were no differences in the percent of patients presenting to the emergency department, being readmitted, calling the office, calling the office regarding pain, or requesting opioid prescriptions within 30 days of discharge, or the number of post-operative office visits (P >.05 for all). CONCLUSION:Patients can safely be discharged home without opioids following cystectomy, regardless of robotic or open approach. Age and pathology are predictors of the need for an opioid prescription on discharge. These patients did not have increased follow-up visits, phone calls, or requests for pain medication.
PMID: 36055420
ISSN: 1527-9995
CID: 5944792
Outcomes of Vesicourethral Anastomotic Stenosis and Bladder Neck Contracture With Direct Visual Internal Urethrotomy With Mitomycin-C After Prostate Cancer Treatment
Hacker, Emily C; Maganty, Avinash; Pere, Maria M; Rusilko, Paul J
OBJECTIVE:To examine the use of Direct Visual Internal Urethrotomy with Mitomycin-C (DVIU-MMC) for bladder neck contracture and vesicourethral anastomotic stenosis in men who have undergone treatment for prostate cancer with radical prostatectomy and/or radiation therapy. METHODS:Retrospective chart review of patients at a tertiary care center who underwent DVIU-MMC for recurrent bladder neck contracture/vesicourethral anastomotic stenosis between 2012 and 2020. Patients with complete urethral obliteration, prior bladder neck reconstruction, or less than 3 months of follow-up were excluded. Patients were sorted into three groups based on prostate cancer treatment history: radical prostatectomy (RP), RP with subsequent external beam radiation therapy (RP-EBRT), and radiation therapy (RT). RESULTS:Fifty-one patients with a median follow up of 32 months were included. Twenty-nine percent had pre-operative suprapubic tube (SPT), Foley, or required clean intermittent catheterization. Overall success after initial DVIU-MMC was 45%. In all patients with up to four procedures, cumulative overall success was 84%. There was no significant difference in relative success rates between groups. However, the interval to recurrence after initial DVIU-MMC was shortest for RP-EBRT group (P = .018). Three patients required SPT, all were in the RP-EBRT group. There was no statistical difference in recurrence after any number of procedures between patients in radiation (RP-EBRT and RT) and non-radiation (RP) groups. CONCLUSION:There was no significant difference in success rates between patients who had undergone RP-EBRT, RT, or RP. However, our data suggests that RP-EBRT patients experience poorer outcomes given that their interval to recurrence was more rapid and all patients requiring SPT placement were in this group.
PMID: 35167882
ISSN: 1527-9995
CID: 5944782
Defining 24-hour urine parameters and kidney stone risk of student athletes
Theisen, Katherine M; Ayyash, Omar; Pere, Maria; Ferroni, Matthew; Riley, Julie; Averch, Timothy D; Semins, Michelle J
PURPOSE/OBJECTIVE:Dehydration is a risk factor for kidney stone formation. Studying populations that may experience dehydration without a known increased incidence of stone formation may help understand stone formation and prevention. High-caliber athletes represent such a population. We characterized the urinary environment of high-caliber athletes utilizing 24-hour urine collections with comparison to non-athlete controls. MATERIALS AND METHODS/METHODS:After Institutional Review Board (IRB) and National Collegiate Athletic Association (NCAA) compliance officer approval, 74 college-student athletes and 20 non-athletes were enrolled. Demographics, medical history, and sport of participation were recorded. Participants were asked to provide 24-hour urine collections as well as diet and activity logs at the time of urine collection. Standard stone risk parameters were assessed and compared to litholink reference standards. RESULTS:34 athletes and 10 non-athletes provided at least one 24-hour urine specimen for evaluation. Athletes had a high prevalence of urinary risks for stone formation including low volume (median 1.46 L), low citrate, high sodium, high calcium (females), and high uric acid (males). However, athletes also had a high prevalence of known stone-protective factors such as high urine magnesium. Athletes had a lower urine pH but high supersaturation of uric acid and calcium oxalate compared to non-athletes. CONCLUSION/CONCLUSIONS:Student athletes appear to have a high prevalence of urinary risk factors for stone formation such as dehydration, high calcium, high uric acid, high sodium, and low citrate. Overall stone risk in this population may be offset by increased levels of stone-protective factors such as magnesium. Further study of this population may help generate hypotheses for effective stone prevention strategies in the general population.
PMID: 34784999
ISSN: 0301-0430
CID: 5944772
Large Variation in International Prescribing Rates of Opioids After Robotic Prostatectomy
Hacker, Emily C; Pere, Maria M; Yu, Michelle; Gul, Zeynep G; Jacobs, Bruce L; Davies, Benjamin J
OBJECTIVE:To compare international opioid prescribing patterns for patients undergoing robotic assisted laparoscopic prostatectomy. To our knowledge, this is the first study to assess international opioid prescribing trends among urologists. METHODS:An anonymous Web-based survey assessing the frequency and quantity of opioid prescriptions for robotic assisted laparoscopic prostatectomy was designed using Qualtrics software. The survey was distributed to urologists internationally via Twitter and email in early 2021. Prescribing patterns were analyzed based on country of practice in three groups: United States, Canada, and all other countries. RESULTS:160 participants from 26 countries completed the survey including the United States (51%), Greece (19%), Canada (9%), Israel (3.1%). The percentage of providers prescribing post-discharge opioids significantly differed between Canada, the United States, and other countries (86%, 63%, and 11%, respectively, P <.0001). There was a significant difference between years of experience in those who provide opioids compared to those who do not (8 years vs 5 years, P = .0004). The average morphine milligram equivalents (MME) provided in those who did prescribe opioids was greatest in the United States but was not significantly different between groups (mean MME: United States 58 mg, Canada 46 mg, all others 54 mg; P = .63). Attending physicians prescribed more MME than trainees (residents, fellows) on average (attending mean MME = 75 mg, trainee mean MME = 40 mg, P = .017). CONCLUSION:Opioid prescriptions after robotic assisted prostatectomy are common in North America and used sparingly in the rest of the world.
PMID: 34678308
ISSN: 1527-9995
CID: 5944762