First-in-human Evaluation of a Prostate-specific Membrane Antigen-targeted Near-infrared Fluorescent Small Molecule for Fluorescence-based Identification of Prostate Cancer in Patients with High-risk Prostate Cancer Undergoing Robotic-assisted Prostatectomy.

BACKGROUND: Men with high-risk prostate cancer undergoing surgery likely recur due to failure to completely excise regional and/or local disease. OBJECTIVE: The first-in-human evaluation of safety, pharmacokinetics, and exploratory efficacy of IS-002, a novel near-infrared prostate-specific membrane antigen (PSMA)-targeted fluorescence imaging agent, designed for intraoperative prostate cancer visualization. DESIGN, SETTING, AND PARTICIPANTS: A phase 1, single-center, dose-escalation study was conducted in 24 men with high-risk prostate cancer scheduled for robotic-assisted radical prostatectomy with (extended) pelvic lymph node dissection using the da Vinci surgical system. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Adverse events (AEs), vital signs, complete blood count, complete metabolic panel, urinalysis, and electrocardiogram were assessed over a 14-d period and compared with baseline. The pharmacokinetic profile of IS-002 was determined. Diagnostic accuracy was assessed for exploratory efficacy. RESULTS AND LIMITATIONS: AEs predominantly included discoloration of urine (n = 22/24; expected, related, grade 1). There were no grade ≥2 AEs. IS-002 Cmax and area under the curve increased with increasing dose. Plasma concentrations declined rapidly in a biphasic manner, with the median terminal half-lives ranging from 5.0 to 7.6 h, independent of dose and renal function. At 25 µg/kg, the exploratory efficacy readouts for the negative and positive predictive values were, 97% and 45% for lymph nodes, and 100% and 80% for residual/locoregional disease detection, respectively. CONCLUSIONS: IS-002 is safe and well tolerated, and has the potential to enable intraoperative tumor detection that could not be identified using standard imaging. PATIENT SUMMARY: IS-002 is a new imaging agent that specifically targets the prostate-specific membrane antigen receptor. In this study, we tested IS-002 for the first time in men with high-risk prostate cancer undergoing surgery and found that IS-002 is safe, is cleared from the body quickly, and potentially allows identification of prostate cancer in areas that would not be identified by conventional white light imaging.

The Long-term Incidence and Quality of Life Outcomes Associated With Treatment-Related Toxicities of External Beam Radiotherapy for Prostate Cancer.

OBJECTIVE: To assess the long-term incidence of treatment-related toxicities and quality of life (QOL) outcomes associated with toxicity after external beam radiotherapy (EBRT) for prostate cancer. METHODS: We identified all men who had EBRT between 1994 and 2017 from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a longitudinal, nationwide prostate cancer registry. CaPSURE was queried for patient-reported and International Classification of Diseases-9/10 and Current Procedural Terminology codes. The Medical Outcomes Studies Short Form 36 and the University of California, Los Angeles Prostate Cancer Index were used to provide measures of general health, sexual, urinary, and bowel function. Repeated measures mixed models were used to determine QOL change after onset of toxicity. RESULTS: From a total of 15,332, 1744 (11.4%) men had EBRT. The median follow-up was 7.9years (interquartile range [IQR] 4.3-12.7). The median time to onset of any toxicity including urinary pad usage in 265 (15.4% at 8years) men was 4.3years (IQR 1.8-8.0). The most frequent toxicity was hemorrhagic cystitis (104, 5.9% at 8years) after a median of 3.7years (1.3-7.8), gastrointestinal (48, 2.7% at 8years) after a median of 4.2years (IQR 1.3-7.8), followed by urethral stricture (47, 2.4% at 8years) after a median of 3.7years (IQR 1.9-9.1). Repeated measures mixed models found that onset of hemorrhagic cystitis was associated with change in general health over time. CONCLUSION: EBRT for prostate cancer is associated with distinct treatment-related toxicities which can occur many years after treatment and can affect QOL. These results may help men understand the long-term implications of treatment decisions.

PSA density does not improve predictive accuracy of the UCSF-CAPRA score.

INTRODUCTION: The University of California, San Francisco Cancer of the Prostate Risk Assessment (CAPRA) score is a validated tool using factors at diagnosis to predict prostate cancer outcomes after radical prostatectomy (RP). This study evaluates whether substitution of prostate-specific antigen (PSA) density for serum PSA improves predictive performance of the clinical CAPRA model. METHODS: Participants were diagnosed in 2000-2019 with stage T1/T2 cancer, underwent RP, with at least a 6-month follow-up. We computed standard CAPRA score using diagnostic age, Gleason grade, percent positive cores, clinical T stage, and serum PSA, and an alternate score using similar variables but substituting PSA density for PSA. We reported CAPRA categories as low (0-2), intermediate (3-5), and high (6-10) risk. Recurrence was defined as two consecutive PSA ≥ 0.2 ng/mL or receipt of salvage treatment. Life table and Kaplan-Meier analysis evaluated recurrence-free survival after prostatectomy. Cox proportional hazards regression models tested associations of standard or alternate CAPRA variables with recurrence risk. Additional models tested associations between standard or alternate CAPRA score with recurrence risk. Cox log-likelihood ratio test (-2 LOG L) assessed model accuracy. RESULTS: A total of 2880 patients had median age 62 years, GG1 30% and GG2 31%, median PSA 6.5, and median PSA density 0.19. Median postoperative follow-up was 45 months. Alternate CAPRA model was associated with shifts in risk scores, with 16% of patients increasing and 7% decreasing (p < 0.01). Recurrence-free survival after RP was 75% at 5 years and 62% at 10 years. Both CAPRA component models were associated with recurrence risk after RP on Cox regression. Covariate fit statistics showed better fit for standard CAPRA model versus alternate (p < 0.01). Standard (hazard ratio [HR]: 1.55; 95% confidence interval [CI]: 1.50-1.61) and alternate (HR: 1.50; 95% CI: 1.44-1.55) CAPRA scores were associated with recurrence risk, with better fit for standard model (p < 0.01). CONCLUSIONS: In a 2880 patient cohort followed for median 45 months after RP, alternate CAPRA model using PSA density was associated with higher biochemical recurrence (BCR) risk, but performed inferior to standard CAPRA at predicting BCR. While PSA density is an established prognostic variable in prediagnostic settings and sub-stratifying low-risk disease, it does not improve BCR model predictive accuracy when applied across a range of cancer risk.

Stability of Prognostic Estimation Using the CAPRA Score Incorporating Imaging-based vs Physical Exam-based Staging.

PURPOSE: Although official T-staging criteria for prostate cancer are based on digital rectal examination findings, providers increasingly rely on transrectal US and MRI to define pragmatic clinical stage to guide management. We assessed the impact of incorporating imaging findings into T-staging on performance of a well-validated prognostic instrument. MATERIALS AND METHODS: Patients who underwent radical prostatectomy for prostate cancer diagnosed between 2000 and 2019 with stage ≤cT3a on both digital rectal examination and imaging (transrectal US/MRI) were included. The University of California, San Francisco CAPRA (Cancer of the Prostate Risk Assessment) score was computed 2 ways: (1) incorporating digital rectal examination-based T stage and (2) incorporating imaging-based T stage. We assessed for risk changes across the 2 methods and associations of CAPRA (by both methods) with biochemical recurrence, using unadjusted and adjusted Cox proportional hazards models. Model discrimination and net benefit were assessed with time-dependent area under the curve and decision curve analysis, respectively. RESULTS: Of 2,222 men included, 377 (17%) increased in CAPRA score with imaging-based staging (P < .01). Digital rectal examination-based (HR 1.54; 95% CI 1.48-1.61) and imaging-based (HR 1.52; 95% CI 1.46-1.58) CAPRA scores were comparably accurate for predicting recurrence with similar discrimination and decision curve analyses. On multivariable Cox regression, positive digital rectal examination at diagnosis (HR 1.29; 95% CI 1.09-1.53) and imaging-based clinical T3/4 disease (HR 1.72; 95% CI 1.43-2.07) were independently associated with biochemical recurrence. CONCLUSIONS: The CAPRA score remains accurate whether determined using imaging-based staging or digital rectal examination-based staging, with relatively minor discrepancies and similar associations with biochemical recurrence. Staging information from either modality can be used in the CAPRA score calculation and still reliably predict risk of biochemical recurrence.

The effect of preoperative membranous urethral length on likelihood of postoperative urinary incontinence after robot-assisted radical prostatectomy.

BACKGROUND: Urinary incontinence after radical prostatectomy affects many men. In addition to surgical and patient factors, longer preoperative membranous urethral length (MUL) has been suggested to be associated with improved postoperative urinary continence outcomes. Here, we assess the association of preoperative MUL and the risk of persistent postoperative urinary incontinence after robot-assisted radical prostatectomy (RARP) for prostate cancer on extended follow-up. METHODS: All participants underwent RARP at the University of California, San Francisco between 2000-2018. Patients were excluded if preoperative MRI-measured MUL was not performed by a radiologist. A single, blinded urologist remeasured MUL retrospectively. Logistic regression models examined associations between radiologist- and urologist-measured MUL and likelihood of persistent incontinence post-RARP by two definitions: strict incontinence (>0 pad/day) and social incontinence (>1 pad/day). RESULTS: In 251 men with a median follow-up of 42 months (IQR 29-76), the median MUL measurements were 14 mm ([IQR 12-17], radiologist) and 15 mm ([IQR 12-18], urologist) with poor agreement (interclass correlation coefficient 0.34). On logistic regression, urologist-measured longer MUL was associated with lower likelihood of strict incontinence within 6 months (odds ratio [OR] 0.87; 95% confidence interval [CI] 0.81-0.94) and 12 months (OR 0.90; 95% CI 0.82-0.98) and social incontinence within 6 months (OR 0.93; 95% CI 0.86-1.00) and 12 months (OR 0.84; 95% CI 0.74-0.95). Radiologist-measured longer MUL was associated with lower likelihood of strict incontinence within 6 months (OR 0.93; 95% CI 0.87-1.00) and social within 12 months (OR 0.87; 95% CI 0.77-1.00). MUL was not associated with likelihood of strict or social incontinence within 24 months. CONCLUSION: Preoperative MRI-measured MUL was not associated with urinary incontinence after 12 months post-RARP. Poor agreement between radiologists' and urologist's measurements supports standardizing MUL measurements to establish the likelihood of early incontinence.

The Natural History of Untreated Biopsy Grade Group Progression and Delayed Definitive Treatment for Men on Active Surveillance for Early-Stage Prostate Cancer.

PURPOSE: For men with clinically localized prostate cancer outcomes of continuing active surveillance (AS) after biopsy progression are not well understood. We aim to determine the impact of continuing AS and delayed definitive treatment after biopsy progression on oncologic outcomes. MATERIALS AND METHODS: Participants in our prospective AS cohort (1990-2018) diagnosed with grade group (GG) 1, localized prostate cancer, with prostate specific antigen <20 who were subsequently upgraded to ≥GG2, and underwent further surveillance (biopsy/imaging/prostate specific antigen) were identified. Patients were stratified by post-progression followup into 3 groups: continue AS untreated, pursue early radical prostatectomy (RP) ≤6 months, or undergo late RP within 6 months to 5 years of progression. Patients receiving other treatments were excluded. We compared characteristics between groups and examined the associations of early vs late RP with risk of adverse pathology (AP) at RP and recurrence-free survival (RFS) after RP. RESULTS: Of 531 patients with biopsy progression and further surveillance 214 (40%) remained untreated, 192 (36%) pursued early RP and 125 (24%) underwent late RP. Among patients who underwent early vs late RP, there was no difference in GG (p=0.15) or AP (55% vs 53%, p=0.74) rate at RP, or 3-year RFS (80% vs 87%, log-rank p=0.64) after RP. In multivariable models, only Cancer of Prostate Risk Assessment post-surgical score was associated with risk of RFS (HR=1.42 per point, 95% CI 1.24-1.64). CONCLUSIONS: Among patients continuing AS after biopsy progression, 60% underwent surgery within 5 years. Delayed surgery after progression was not associated with higher risk of AP or RFS. This suggests select patients may be able to safely delay treatment after progression.

Natural history of an immediately detectable PSA following radical prostatectomy in a contemporary cohort.

BACKGROUND: A detectable prostate-specific antigen (PSA) following radical prostatectomy (RP) is an unfavorable prognostic factor. However, not all men with a detectable PSA experience recurrence. We describe the natural history and outcomes in men with a detectable PSA following RP in a contemporary cohort. METHODS: A retrospective analysis of men who underwent RP for non-metastatic prostate cancer at the University of California, San Francisco from 2000 to 2020 was performed. A detectable PSA was defined as PSA ≥ 0.03 ng/ml within 6 months of RP. Cox regression models tested the effect of detectable PSA on the development of metastasis, prostate cancer-specific mortality, and overall survival. RESULTS: We identified 2941 men who had RP with 408 (13.9%) with a detectable PSA within the first 6 months. The median follow-up was 4.42 years (interquartile range [IQR], 2.58-8.00). In total, 296 (72.5%) men with a detectable PSA had salvage treatment at a median of 6 months (IQR, 4-11). One hundred sixteen of these men had PSA failure after salvage treatment at a median of 2.0 years (IQR, 0.7-3.8). On multivariable Cox regression, the risk of development of metastasis (hazard ratio [HR], 1.05; 95% confidence interval [CI], 1.01-1.09; p = .01), prostate cancer-specific mortality (HR, 1.13; 95% CI, 1.05-1.21; p = .0005), and overall mortality (HR, 1.07; 95% CI, 1.03-1.12; p = .002) was associated with PSA velocity after salvage treatment in men with a detectable PSA. CONCLUSIONS: Men with a detectable PSA after RP may have excellent long-term outcomes. PSA velocity after salvage treatment may be an important predictor for the development of metastasis, prostate cancer-specific mortality, and overall mortality.

Residual Benign Prostate Glandular Tissue after Radical Prostatectomy is Not Associated with the Development of Detectable Postoperative Serum Prostate Specific Antigen.

PURPOSE: To determine if benign glandular tissue at the surgical margin (BGM) is associated with detectable prostate specific antigen (PSA) and/or biochemical recurrence (BCR) after radical prostatectomy (RP). MATERIALS AND METHODS: Participants underwent RP for localized prostate cancer between 2004 and 2018. Regression analysis was used to identify demographic, clinical and surgical factors associated with the likelihood of BGM presence on surgical pathology. Oncologic outcomes included detectable PSA (>0.03 ng/ml), BCR (≥0.2 ng/ml) and progression to BCR or salvage treatment after detectable PSA. Life tables and Cox proportional hazards regression models were used to determine the association of BGM and risk of oncologic outcomes. RESULTS: A total of 1,082 men underwent RP for localized prostate cancer with BGM reported on surgical pathology and an undetectable postoperative PSA. BGM was present on 249 (23%) specimens. Younger age, bilateral nerve sparing surgery and robotic approach were associated with presence of BGM while malignancy at the surgical margin (MSM) was not. At 7 years after RP, 29% experienced detectable PSA and 11% had BCR. In the subgroup of men who reached detectable PSA, 79% had progression within 7 years. On multivariate Cox proportional hazards regression, BGM status was not independently associated with detectable PSA, BCR and/or progression from detectable PSA to BCR or salvage treatment. CONCLUSIONS: The presence of BGM at RP was not associated with increased risk of MSM, detectable PSA, BCR or progression after detectable PSA.

A Comparison of Respiratory Outcomes after Treating Retinopathy of Prematurity with Laser Photocoagulation or Intravitreal Bevacizumab.

PURPOSE: To compare respiratory outcomes after treatment of retinopathy of prematurity (ROP) between infants treated with laser therapy under general anesthesia and infants treated with intravitreal bevacizumab under bedside sedation. DESIGN: Retrospective cohort study. PARTICIPANTS: One hundred thirty-eight consecutive infants treated for ROP from September 2010 through September 2018 at 1 institution. METHODS: Retrospective medical, procedural, and ophthalmologic data were collected, including preprocedure (baseline) and postprocedure (24 hours, 48 hours, 7 days, and 28 days) respiratory status, birth weight, gestational age, gender, ROP treatment method, postmenstrual age at treatment, and coincident nonocular procedures during anesthesia. Respiratory outcomes at 48 hours were compared between infants treated with laser therapy under general anesthesia and infants treated with intravitreal bevacizumab under local sedation using multivariate logistic regression analysis to control for potentially confounding factors. MAIN OUTCOME MEASURES: Proportion of infants who had returned to their respiratory baseline by 48 hours after ROP treatment. RESULTS: Return to respiratory baseline was significantly less common among 119 infants initially treated with laser therapy compared with 19 infants initially treated with bevacizumab at 24 hours (40% vs. 74%; P = 0.0115), 48 hours (53% vs. 79%; P = 0.0453), and 7 days (79% vs. 100%; P = 0.0242). In a multivariate logistic regression analysis, infants treated with laser therapy were less likely to return to respiratory baseline at 48 hours (odds ratio, 0.14; 95% confidence interval, 0.04-0.54). At 28 days, no difference was found between groups (laser, 97%; bevacizumab, 100%; P > 0.99). CONCLUSIONS: Infants treated with intravitreal bevacizumab using bedside sedation returned to their preprocedure respiratory baseline faster than infants treated with laser under general anesthesia, with the differences persisting at least to 7 days or more after the procedure.

WITHDRAWN: Quantification of changes in eyelid position in patients with dry eye syndrome: A randomized, placebo-controlled multicenter study of application of topical anesthetic.

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Slow-pathway visualization by using voltage-time relationship: A novel technique for identification and fluoroless ablation of atrioventricular nodal reentrant tachycardia.

BACKGROUND: Atrioventricular nodal reentrant tachycardia (AVNRT) is treatable by catheter ablation. Advances in mapping-system technology permit fluoroless workflow during ablations. As national practice trends toward fluoroless approaches, easily obtained, reproducible methods of slow-pathway identification, and ablation become increasingly important. We present a novel method of slow-pathway identification and initial ablation results from this method. METHODS AND RESULTS: We examined AVNRT ablations performed at our institution over a 12-month period. In these cases, the site of the slow pathway was predicted by latest activation in the inferior triangle of Koch during sinus rhythm. Ablation was performed in this region. Proximity of the predicted site to the successful ablation location, complication rates, and patient outcomes were recorded. Junctional rhythm was seen in 40/41 ablations (98%) at the predicted site (mean, 1.3 lesions and median, 1 lesion per case). One lesion was defined as 5 mm of ablation. The initial ablation was successful in 39/41 cases (95%); in two cases, greater or equal to 2 echo beats were detected after the initial ablation, necessitating further lesion expansion. In 8/41 cases (20%), greater than one lesion was placed during initial ablation before attempted reinduction. Complications included one transient heart block and one transient PR prolongation. During follow-up (median, day 51), one patient had lower-extremity deep-vein thrombosis and pulmonary embolus, and one had a lower-extremity superficial venous thrombosis. There was one tachycardia recurrence, which prompted a redo ablation. CONCLUSIONS: Mapping-system detection of late-activation, low-amplitude voltage during sinus rhythm provides an objective, and fluoroless means of identifying the slow pathway in typical AVNRT.

Percutaneous Biopsy Tract Seeding in a Patient with Muscle-invasive Bladder Cancer.

Percutaneous biopsy can be used for tissue diagnosis of bladder tumors when cystoscopy with transurethral resection is not possible. The largest known case series includes 15 patients with no reported complications and good concordance with surgical pathology. However, concern remains regarding exposure of nonurothelial surfaces to tumor cells, as there are rare documented cases of tumor seeding along nephrostomy and biopsy tracts in upper tract urothelial carcinoma (UC). We present the first documented human case of bladder cancer involvement of the omentum and peritoneum along a biopsy tract and review the use of percutaneous access for upper and lower tract UC.

Short-term retinal detachment risk after treatment of type 1 retinopathy of prematurity with laser photocoagulation versus intravitreal bevacizumab.

PURPOSE: To perform a stratified comparison of the short-term risk of retinal detachment after treatment of type 1 retinopathy of prematurity treated with panretinal photocoagulation laser versus intravitreal bevacizumab. METHODS: The medical records of consecutive infants treated for type 1 ROP between 2010 and 2018 were retrospectively reviewed. An a priori decision was made to divide infants into two groups, those treated before postmenstrual age (PMA) of 36 0/7 weeks and those treated at or after PMA of 36 0/7 weeks. The primary outcome was presence of any retinal detachment (stage 4A, 4B, or 5) during the 8 weeks following treatment. RESULTS: A total of 222 eyes of 115 infants were included. In eyes treated before 36 0/7 weeks' PMA, retinal detachment occurred in 0 of 34 eyes treated initially with bevacizumab compared with 9 of 56 (16%) treated with laser (P = 0.0112); in eyes treated at or after 36 0/7 weeks, in 0 of 2 eyes treated with bevacizumab and 1 of 130 eyes (0.8%) treated with laser. CONCLUSIONS: The short-term risk of retinal detachment among infants requiring treatment for type 1 ROP prior to 36 0/7 weeks' PMA was lower in eyes treated with intravitreal bevacizumab than in eyes treated with laser, presumably due to the faster effect of bevacizumab in eyes that have more aggressive ROP.

An Isolated Ureteropelvic Junction Injury Following a Low-impact Mechanical Fall.

OBJECTIVE: To describe the presentation of a rare isolated ureteropelvic junction injury resulting from a mechanical fall on ice. MATERIALS AND METHODS: A 71-year-old previously healthy man presented to the emergency department at the University of Massachusetts Medical School 3 hours following falling on ice with complaints of gross hematuria and flank pain. Patient records were accessed via the institution's electronic medical records system between March 22, 2018 and April 22, 2018. RESULTS: Abdominal imaging revealed urinary extravasation without evidence of accompanying injury to surrounding structures, confirming an isolated left ureteropelvic junction injury. CONCLUSION: Isolated ureteral injury following low-impact blunt abdominal trauma is exceedingly rare. Furthermore, this patient's presentation challenges the accepted conventions for both mechanism of injury and accompanying clinical factors in ureteral trauma.

Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial.

The growing need for symptomatic treatment of post-traumatic neuropathic pain (PTNP) continues to be unmet. Studies evaluating the efficacy of pregabalin for reducing neuropathic pain following trauma and surgery yielded positive results over ≤ 8-week treatment. To assess the efficacy and tolerability of pregabalin over 3 months in patients with PTNP, a randomized, double-blind, placebo-controlled, parallel-group trial evaluated patients with PTNP at 101 centers in 11 countries-the longest, largest such trial. Adults diagnosed with PTNP were randomly assigned (1:1) to 15 weeks of pregabalin (flexibly dosed 150-600 mg/day) or matching placebo. Primary efficacy analysis was by mixed-model repeated measures comparing change from baseline to week 15 in weekly mean pain scores between active and placebo groups. Evaluable patients included 274 in the pregabalin group and 265 in the placebo group. Trauma was surgical in 49.6% of patients, non-surgical in the remainder. The primary efficacy analysis showed no statistically significant difference between pregabalin and placebo groups in the change from baseline to week 15 [mean difference, - 0.22 points (95% confidence interval, 0.54-0.10); p = 0.1823]. However, comparisons for key secondary outcome measures yielded p values < 0.05 favoring pregabalin. Consistent with the known safety profile of pregabalin, the most common adverse events were dizziness and somnolence (14.6 and 9.9% of patients, respectively) with pregabalin (vs 4.2 and 3.4% with placebo). These findings demonstrate the feasibility of conducting a large, phase 3 registration trial in the heterogeneous PTNP study population.ClinicalTrials.gov NCT01701362.

Transitions Clinic Network: Challenges And Lessons In Primary Care For People Released From Prison.

Low-income and minority communities are disproportionately affected by incarceration, which exacerbates health disparities. Through enhanced primary care, the Transitions Clinic Network (TCN) seeks to improve the health of people with chronic conditions who return to their communities from prison. Using TCN data, we assessed the impact of early engagement in primary care and referral from correctional systems to TCN on the use of acute care (emergency department visits and hospitalizations) and recidivism. Of 751 patients, 29.8 percent were referred by correctional partners, and 52.7 percent were engaged in TCN care within one month after release. In the twelve months after release, patients referred by correctional partners had fewer acute care visits, compared to those referred by community-based partners, while early engagement was associated with more acute care visits. Neither referral by correctional partners nor early engagement was significantly associated with recidivism. Our findings suggest that health equity for this vulnerable population could be achieved through improved coordination between correctional and community health care systems.