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Purpose:Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule prostate-specific membrane antigen–targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging.Experimental Design:Men with rising PSA ≥0.2 ng/mL after prostatectomy or ≥2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization between 18F-DCFPyL-PET/CT and a composite standard of truth (SOT). The SOT consisted of, in descending priority (i) histopathology, (ii) subsequent correlative imaging findings, or (iii) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval (CI) for CLR exceeded 20% for two of three 18F-DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety.Results:A total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2–98.4 ng/mL) underwent 18F-DCFPyL-PET/CT. The CLR was 84.8%–87.0% (lower bound of 95% CI: 77.8–80.4). A total of 63.9% of evaluable patients had a change in intended management after 18F-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers).Conclusions:Performance of 18F-DCFPyL-PET/CT achieved the study’s primary endpoint, demonstrating disease localization in the setting of negative standard imaging and providing clinically meaningful and actionable information. These data further support the utility of 18F-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer.See related commentary by True and Chen, p. 3512

The manuscript reports the results of a study that explored what facilitates and hinders local emergency management program pursuit of accreditation by the Emergency Management Accreditation Program (EMAP). This research question is of significance for several reasons, including, (1) leading national emergency management organizations have endorsed The Emergency Management Standard promulgated by EMAP; (2) very few programs are accredited; and, (3) there are only two studies related to accreditation in emergency management and neither examines accreditation in a local context. Analysis of semi-structured interview data from local emergency management program leaders representing some of the largest municipalities in the United States revealed a variety of key themes regarding what facilitates or hinders accreditation pursuit. The complexity of these themes and the context which produces them suggests that widespread accreditation at the local level is not likely in the near future even though many leaders valued the Standard and accreditation. This conclusion is discussed and a variety of avenues that might be pursued if more accreditation of local programs were the goal is offered.

Purpose: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule prostate-specific membrane antigen–targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging. Experimental Design: Men with rising PSA ≥0.2 ng/mL after prostatectomy or ≥2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization between 18F-DCFPyL-PET/CT and a composite standard of truth (SOT). The SOT consisted of, in descending priority (i) histopathology, (ii) subsequent correlative imaging findings, or (iii) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval (CI) for CLR exceeded 20% for two of three 18F-DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety. Results: A total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2–98.4 ng/mL) underwent 18F-DCFPyL-PET/CT. The CLR was 84.8%–87.0% (lower bound of 95% CI: 77.8–80.4). A total of 63.9% of evaluable patients had a change in intended management after 18F-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers). Conclusions: Performance of 18F-DCFPyL-PET/CT achieved the study’s primary endpoint, demonstrating disease localization in the setting of negative standard imaging and providing clinically meaningful and actionable information. These data further support the utility of 18F-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer. See related commentary by True and Chen, p. 3512

Summative assessment data are rarely adapted into instructional decision making. In this project, teachers and researchers work together to identify how teachers use diagnostic data (students’ deve...

The job placement of emergency management degree program graduates has been an enduring point of conversation for over a decade https://training.fema.gov/hiedu/readinglist.aspx, https://www.hsdl.org/?view&did=478470, https://doi.org/10.2202/1547-7355.1910, https://training.fema.gov/hiedu/readinglist.aspx, https://training.fema.gov/hiedu/readinglist.aspx, https://training.fema.gov/hiedu/latest/2018.aspx. Whether graduates are employable, whether they are getting jobs, and why some get jobs and others do not have been of concern. Yet, until recently, no empirical study had examined the extent to which emergency management degree holders who want emergency management jobs actually get them. Jensen and Kirkpatrick (2020), found that the majority of graduates who intended such jobs got them, while almost a third did not. Jensen and Kirkpatrick (2019), proposed a theoretical framework that might guide research on job outcomes of emergency management degree program graduates, including job placement. This manuscript reports the authors' efforts to utilize the theoretical framework to explore the difference between those graduates who wanted and secured an emergency management position post-graduation and those who wanted one but did not. Specifically, this manuscript reports initial findings and challenges related to this question in the context of a theoretical framework of job placement and the current state of emergency management higher education nationally.

Graduate job placement is an important issue for emergency management higher education programs, practitioners, and students. Yet, despite considerable discussion about the topic, no line of empirical research has emerged. This article begins to address this gap by reporting the findings of an exploratory study that examined the actual job placement of students who recently graduated with a bachelor’s degree in emergency management and the extent to which their placement was consistent with their intent. This study found that the vast majority of recent graduates are indeed securing jobs they want, but, for about half, the jobs they want are not emergency management. There is significant diversity in the career-paths and sectors being pursued by graduates. This article discusses the potential implications of these findings as well as the critical need for further research in this area.

Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR).Men with rising PSA ≥0.2 ng/mL after prostatectomy or ≥2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization betweenA total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2-98.4 ng/mL) underwentPerformance of

Introduction:Improved diagnostics are needed to better inform the treatment of men with biochemically recurrent (BCR) prostate cancer (PCa). 18F-DCFPyL is a novel PET agent that selectively binds w...

Patients with metastatic or unresectable (advanced) pheochromocytoma and paraganglioma (PPGL) have poor prognoses and few treatment options. This multicenter, phase 2 trial evaluated the efficacy and safety of high-specific-activity 131I-meta-iodobenzylguanidine (HSA 131I-MIBG) in patients with advanced PPGL. Methods: In this open-label, single-arm study, 81 PPGL patients were screened for enrollment, and 74 received a treatment-planning dose of HSA 131I-MIBG. Of these patients, 68 received at least 1 therapeutic dose (∼18.5 GBq) of HSA 131I-MIBG intravenously. The primary endpoint was the proportion of patients with at least a 50% reduction in baseline antihypertensive medication use lasting at least 6 mo. Secondary endpoints included objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors version 1.0, biochemical tumor marker response, overall survival, and safety. Results: Of the 68 patients who received at least 1 therapeutic dose of HSA 131I-MIBG, 17 (25%; 95% confidence interval, 16%–37%) had a durable reduction in baseline antihypertensive medication use. Among 64 patients with evaluable disease, 59 (92%) had a partial response or stable disease as the best objective response within 12 mo. Decreases in elevated (≥1.5 times the upper limit of normal at baseline) serum chromogranin levels were observed, with confirmed complete and partial responses 12 mo after treatment in 19 of 28 patients (68%). The median overall survival was 36.7 mo (95% confidence interval, 29.9–49.1 mo). The most common treatment-emergent adverse events were nausea, myelosuppression, and fatigue. No patients had drug-related acute hypertensive events during or after the administration of HSA 131I-MIBG. Conclusion: HSA 131I-MIBG offers multiple benefits, including sustained blood pressure control and tumor response in PPGL patients.

Context No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States. Objective To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL. Design Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg. Setting Three centers. Patients Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity. Intervention Open-label use of high-specific-activity I-131 MIBG therapy. Main Outcome Measures Dose-limiting toxicities, adverse events, radiation absorbed dose estimates, radiographic tumor response, biochemical response, and survival. Results The MTD was determined to be 296 MBq/kg on the basis of two observed dose-limiting toxicities at the next dose level. The highest mean radiation absorbed dose estimates were in the thyroid and lower large intestinal wall (each 1.2 mGy/MBq). Response was evaluated by total administered activity: four patients (19%), all of whom received >18.5 GBq of study drug, had radiographic tumor responses of partial response by Response Evaluation Criteria in Solid Tumors. Best biochemical responses (complete or partial response) for serum chromogranin A and total metanephrines were observed in 80% and 64% of patients, respectively. Overall survival was 85.7% at 1 year and 61.9% at 2 years after treatment. The majority (84%) of adverse events were considered mild or moderate in severity. Conclusions These findings support further development of high-specific-activity I-131 MIBG for the treatment of metastatic and/or recurrent PPGL at an MTD of 296 MBq/kg.

Objective: As a distributed function, emergency management in higher education must involve students from outside the field. An introductory emergency management course was redesigned to be attractive and visible to nonmajors via approval for inclusion in the university’s core general education curriculum. Design: Pre- / post comparisons were made of enrollment data for two interventions intended to broaden the course’s audience. Later, a survey assessed why students took the course. Setting: A land grant research university serving over 14,000 undergraduate and graduate students. Participants: Participants were students taking the Department’s introductory course. Interventions: Two interventions involved the Department’s entry level course originally titled, “Introduction to Emergency Management” and numbered at the sophomore level. First, the Department retitled the course, “Emergencies, Disasters, and Catastrophes,” and renumbered the course at the freshman level. Second, the Department later requested and received approval to have the course accepted in the University’s general education curriculum. Main outcome measures: Interventions were assessed by examining the average, annual number of nonmajors in the course, as well as, the academic diversity present among nonmajors. Results: Both interventions, and especially the general education intervention, increased both enrollment measures. Conclusions: A rapid approval for the course’s inclusion in general education validated faculty’s acceptance of emergency management as an academic discipline while each intervention increased both the number and academic diversity of nonmajors. Long-term, the result should prepare nonemergency management leaders for emergency management as a distributed function.

INTRODUCTION AND OBJECTIVES:99mTc-MIP-1404 (1404) is a small molecule SPECT imaging agent that binds to prostate-specific membrane antigen (PSMA) allowing for the detection of prostate cancer (PCa)...

Introduction: Iobenguane scan positive cancers including pheochromocytoma/paraganglioma (PPGL), neuroblastoma, and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are heterogeneous tumors that arise from neuroendocrine cells. Recently, high-specific-activity I-131 meta-iodobenzylguanidine (HSA I-131 MIBG, AZEDRA®) was approved in the US for treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic PPGL. We present a pooled analysis of all available clinical trials to further assess the safety profile of HSA I-131 MIBG. Methods: 118 patients from four HSA I-131 MIBG clinical trials (NCT00339131; NCT00458952; NCT00874614; NCT00659984) were included in a pooled analysis for safety assessments. Adverse events (AEs), laboratory tests, number and quantity of HSA I-131 MIBG doses, hypertensive events, blood pressure (BP), heart rate, ECG, and AEs of special interest (AESI) were analyzed using descriptive statistics. Results: Gastrointestinal (GI) toxicities, especially nausea and vomiting, were the most common AEs associated with HSA I-131 MIBG. GI toxicities were not reported after dosimetry doses. GI, blood and lymphatic system, and vascular disorders were higher in PPGL than in neuroblastoma after therapeutic dose 1 when compared to therapeutic dose 2. The incidence of potentially clinically significant changes in BP was similar following dosimetric and therapeutic doses and are consistent with the underlying hypertension associated with PPGL. No spike in systolic and diastolic BP was observed within the first 4 hours of HSA I-131 MIBG administration, and there were no acute hypertensive crises following dosing. A possibly drug-related mild increase in BP within 48 hours of therapeutic dosing was observed in 1 subject with PPGL. Variations in heart rate (>20 beats/min) were higher after therapeutic dose 1 than after other doses. No clinically significant trends were seen in mean ECG results or mean changes from baseline. All patients received at least one concomitant medication. About 40% of patients received β-blockers, 39% α-blockers, and about 27% other peripheral vasodilators. 87.3% of patients reported an AESI, defined as AEs that are related to the acute and/or chronic effects of radiation toxicity seen any time post dosing. The most common AESIs were nausea (66.1%), thrombocytopenia (50.0%), fatigue (50.0%), neutropenia (42.4%), and diarrhea (22.9%). The incidence of most AESIs were similar after each therapeutic dose. Conclusions: HSA I-131 MIBG demonstrated a favorable safety profile in iobenguane scan positive cancers. AEs followed an expected pattern comparable to other radioactive therapeutic agents. Most cardiovascular events, including hypertensive events mostly commonly observed in PPGL, were not considered related to HSA I-131 MIBG.

INTRODUCTION AND OBJECTIVES:Prostate-specific membrane antigen (PSMA) is a transmembrane protein that is overexpressed by prostate cancer (PCa) cells and can be targeted using the novel PET radiotr...

Training or Educating Emergency Management practitioners and academics are crucial to disaster risk reduction. However, not much is known about higher education program development, specifically, degree program development in Emergency Management. This paper seeks to find factors that help and or hinder Emergency Management higher education program development. An interpretive constructionist perspective method was used to analyze data collected through purposive and snowball sampling. Nineteen emergency management scholars and practitioners who have been involved with Ghana’s efforts, and additional six faculty members who have been involved with developing other new degree programs in four Ghanaian universities were also selected through snowball sampling for the purposes of comparison. Data was collected through in-depth semi-structured face-to-face and telephone interviews. The results suggest six main factors explain why Ghana has not yet established an Emergency Management degree program. The factors include institutional support, partnership, advocacy, funding, program marketing, and cultural factors. In addition to laying theoretical foundation for studies in this area, the relative novelty of Disaster/Emergency Management degree programs, make findings of this study, a checklist for institutions looking into establishing Disaster or Emergency Management degree programs in future.

5023 Background: PSMA-targeted PET/CT is superior to conventional imaging modalities to localize biochemically recurrent (BCR) PCa after local therapy, particularly in pts with low PSA ( < 2 ng/mL). However, few studies have reported PSMA-targeted PET/CT accuracy compared to a pre-specified rigorous standard of truth (SOT) including histopathology, correlative imaging or treatment response in this population. Here, we report the CLR and PPV of PSMA-targeted 18F-DCFPyLPET/ CT, for each of the pre-defined SOT criteria for the CONDOR prospective phase 3 study. Methods: The study enrolled men with rising PSA after definitive therapy and negative or equivocal standard of care imaging (e.g., CT/MRI, bone scintigraphy, F-18 fluciclovine). A single 9 mCi (333 MBq) ± 20% dose of 18F-DCFPyL was injected, followed by PET/CT 1-2 hours later. Pts with positive 18F-DCFPyL-PET/CT scans based on local interpretation were scheduled for follow up within 60 days to verify suspected lesion(s) using a composite SOT. The primary endpoint was CLR defined as PPV with the requirement of anatomic lesion co-localization between 18F-DCFPyL-PET/CT and the SOT. The SOT consisted of, in descending priority: 1) histopathology, 2) subsequent correlative imaging findings determined by twocentral readers, or 3) post-radiation PSA response. The trial was successful if the lower bound of the 95% confidence interval for CLR exceeded 20% for at least two of three independent, blinded central 18F-DCFPyL-PET/CT reviewers. Results: 208 men (median PSA 0.8 ng/mL) underwent 18F-DCFPyL-PET/CT and the study achieved its primary endpoint: CLR was between 84.8% to 87.0% (lower bound of 95% CI: 77.8%-80.4%) among the three 18F-DCFPyL-PET/CT readers, against the composite SOT. The performance of 18F-DCFPyL-PET/CT by CLR (≥1 lesion co-localized) and PPV (≥1 lesion confirmed) was maintained through all 3 SOT categories. Histopathology (N = 31): 78.6-82.8% and 92.9-93.3% for CLR and PPV, respectively; correlative imaging (N = 100): 86.1-88.6% and 87.0-89.5% for CLR and PPV, respectively; and PSA response (N = 1): 100% for both CLR and PPV. Further analyses of the correlative imaging results showed CLR remained high across the different modalities used a) 18F-fluciclovine-PET/CT (N = 71): (86.8-90.9%); b) MRI (N = 23): (80.0-86.7%); and c) CT (n = 6): (80.0-100%). Conclusions: PSMA-targeted 18F-DCFPyL-PET/CT detected and localized metastatic lesions with high CLR and PPV regardless of which criterion defined CLR that was used, in men with BCR who had negative or equivocal baseline imaging. Clinicaltrials.gov: NCT03739684 Clinical trial information: NCT03739684.

TPS5087 Background: Treatment options with minimal toxicity and novel mechanisms of action are urgently needed to improve clinical outcomes from mCRPC. Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) represents a new treatment for patients with PSMA-avid mCRPC. 177Lu-PNT2002 (also known as [Lu-177]-PSMA-I&T) is a PSMA-targeting agent and studies have shown demonstrable promising initial data. This trial seeks to prospectively evaluate the efficacy of 177Lu-PNT2002 for men with progressive mCRPC after androgen receptor axis-targeted (ARAT) therapy. Methods: This is a multi-center, open-label, phase III study. All patients must be at least 18 years of age, have documented progressive mCRPC at time of screening, high PSMA expression by PSMA PET/CT per blinded independent central review (BICR), chemotherapy naïve for CRPC and unfit or unwilling to receive chemotherapy. The study will commence with a 25-patient dosimetry lead-in. In the dosimetry phase, patients will receive up to four cycles of 177Lu-PNT2002 at 6.8 GBq every 8 weeks. In the randomization phase, approximately 390 patients will be randomized in a 2:1 ratio to receive 177Lu-PNT2002 (Arm A) versus enzalutamide or abiraterone (with prednisone or dexamethasone) (Arm B). Patients randomized to Arm B have an option to crossover to 177Lu-PNT2002 treatment after BICR-assessed radiologic progression. The primary endpoint is Radiological progression-free survival (rPFS) assessed by BICR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG3) (bone) criteria. Key secondary endpoints include objective response rate, duration of response, PSA response, and overall survival. The study is powered at 90% to test the alternative hypothesis of a hazard ratio (HR) ≤ 0.66 at an α of 0.025. ClinicalTrials.gov identifier: NCT04647526. Clinical trial information: NCT04647526.

Background: Treatment options with minimal toxicity and novel mechanisms of action are urgently needed to improve clinical outcomes from mCRPC. Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) represents a new treatment for patients with PSMA-avid mCRPC. 177Lu-PNT2002 (also known as [Lu-177]-PSMA-I&T) is a PSMA-targeting agent and studies have shown demonstrable promising initial data. This trial seeks to prospectively evaluate the efficacy of 177Lu-PNT2002 for men with progressive mCRPC after androgen receptor axis-targeted (ARAT) therapy. Methods: This is a multi-center, open-label, phase III study. All patients must be at least 18 years of age, have documented progressive mCRPC at time of screening, high PSMA expression by PSMA PET/CT per blinded independent central review (BICR), chemotherapy naïve for CRPC and unfit or unwilling to receive chemotherapy. The study will commence with a 25-patient dosimetry lead-in. In the dosimetry phase, patients will receive up to four cycles of 177Lu-PNT2002 at 6.8 GBq every 8 weeks. In the randomization phase, approximately 390 patients will be randomized in a 2:1 ratio to receive 177Lu-PNT2002 (Arm A) versus enzalutamide or abiraterone (with prednisone or dexamethasone) (Arm B). Patients randomized to Arm B have an option to crossover to 177Lu-PNT2002 treatment after BICR-assessed radiologic progression. The primary endpoint is Radiological progression-free survival (rPFS) assessed by BICR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG3) (bone) criteria. Key secondary endpoints include objective response rate, duration of response, PSA response, and overall survival. The study is powered at 90% to test the alternative hypothesis of a hazard ratio (HR) ≤ 0.66 at an α of 0.025. ClinicalTrials.gov identifier: NCT04647526. Citation Format: Kim N. Chi, Ur Metser, Johannes Czernin, Jeremie Calais, Vikas Prasad, Matthias Eiber, Neal Shore, Jessica Jensen, Neil Fleshner, Scott Tagawa, Oliver Sartor. Study evaluating metastatic castrate resistant prostate cancer (mCRPC) treatment using 177Lu-PNT2002 PSMA therapy after second-line hormonal treatment (SPLASH) - Trial in progress [abstract]. In: Proceedings of the AACR Virtual Special Conference on Radiation Science and Medicine; 2021 Mar 2-3. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(8_Suppl):Abstract nr PO-077.

32 Background: Conventional imaging and bone scintigraphy are suboptimal modalities for identifying PCa. PSMA-based imaging is highly promising for PCa detection. 18F-DCFPyL is a novel PSMA-targeted radiopharmaceutical for positron emission tomography (PET) that may be useful in staging of PCa. The diagnostic performance, detection rate, and potential impact of 18F-DCFPyL on staging of pts with high- risk PCa have been previously reported. Here we report on the impact of 18F-DCFPyL on staging of pts with PCa recurrence or metastases on conventional imaging. Methods: 18F-DCFPyL-PET/CT was evaluated in 117 men with radiologic evidence of local recurrence or metastatic disease on baseline anatomical imaging (CT, MRI) or whole-body bone scintigraphy and in whom at least one lesion was deemed amenable to biopsy. A single dose of 9 mCi (333 MBq) of 18F-DCFPyL was administered via intravenous injection, followed by PET/CT acquisition 1 to 2 hours thereafter. Based on TNM staging: prostatic (T), pelvic LN (N), extra-pelvic LN (M1a), bone (M1b) and other visceral organs/soft tissue (M1c), 18F-DCFPyL-PET/CT detection rates including lesion counts were systematically analyzed. Three central, blinded, and independent readers evaluated the 18F-DCFPyL scans. Results: In this study, 82 (70%) patients had baseline radiographic M1 stage disease (14 patients with M1a, 50 patients with M1b, 18 patients with M1c) and 33 (28%) patients were M0 stage at baseline by central conventional imaging review; two patients were unevaluable. 18F-DCFPyL-PET/CT up-staged 58% (19/33) of pts from M0 to M1, of whom 91% (10/11) who underwent an extra-pelvic biopsy were confirmed to have M1 disease by pathology, including 9 patients with M1b and 1 patient with M1a. Of the patients who were staged M1 at baseline, 18F-DCFPyL-PET/CT upstaged 16% (10/64; M1a to M1b or M1c: n = 4; M1b to M1c: n = 6) of pts to a higher M1 sub-stage and down-staged 22% (18/82) to M0. Conclusions: 18F-DCFPyL-PET/CT identified M1 disease in the majority of patients examined who otherwise had locoregional disease. These data suggest that 18F-DCFPyL-PET/CT may be a useful tool in properly staging men with both metastatic and nonmetastatic relapsed disease, which could lead to superior treatment paradigms than currently exist using conventional imaging. Clinical trial information: NCT02981368.

Herein we describe a new method to rapidly determine the n-6/n-3 fatty acid ratios in cereal grains and forages (hydroponically-grown cereal sprouts and haylage) using 1H nuclear magnetic resonance (NMR) spectroscopy. This NMR method was found to be consistent with more established but time-consuming gas chromatographic methods (R = 0.994).

In this study, the influence of feeding system on the fatty acid (FA) profile of suckler beef (SB), moderate grain-fed (MG), and grass-fed (GF) beef was compared. It was found that total saturated FA content was not affected; however, greater 14:0, total polyunsaturated FA content, and lower n-6/n-3 ratio suggest some transmittance of milk FA in SB calves (P

5501 Background: Current imaging modalities are inadequate for localizing and characterizing occult disease in men with BCR PCa, particularly in pts with low PSAs (18F-DCFPyL (PyL) is a novel PET imaging agent that binds selectively with high affinity to PSMA, which is overexpressed in PCa cells. Methods: Men ≥18 years- with rising PSA after definitive therapy and negative or equivocal standard of care imaging (e.g., CT/MRI, bone scintigraphy) were enrolled. A single 9 mCi (333 MBq) ± 20% dose of PyL was injected, followed by PET/CT 1-2 hours later. Primary endpoint was correct localization rate (CLR), defined as percentage of pts with a 1:1 correspondence between at least one lesion identified by PyL-PET/CT and the composite standard of truth: pathology, correlative imaging, or PSA response. The trial was successful if the lower bound of the 95% confidence interval (LLCI) for CLR exceeded 20% for two of three independent, blinded central PyL-PET/CT reviewers. The secondary endpoint, impact of PyL-PET/CT on clinical management of pts was based on the treating physician’s documented clinical plans before and after PyL-PET/CT. Results: 208 men (median PSA 0.8 [0.2 - 98.4] ng/mL) underwent PyL PET/CT. The study achieved its primary endpoint: CLR of 84.8% to 87.0% among the three PyL-PET/CT readers; the LLCI for CLR by all three reviewers was >77%. Here we report the clinical impact. Based on local radiology assessment, PSMA-avid lesion(s) were identified in 69.3% (142/208) of pts. 63.9% (131/205) had a change in intended management after PyL-PET/CT, of which 78.6% (103/131) were attributable to positive PyL finding(s) and 21.4% (28/131) to negative PyL scans. Changes included: salvage local therapy to systemic therapy (n=58); observation before initiating therapy (n=49); noncurative systemic therapy to salvage local therapy (n=43); and planned treatment to observation (n=9). PyL was well tolerated with one drug-related SAE (hypersensitivity) and the most common AE being headache (n=4; 1.9%). Conclusions: PSMA-targeted PyL-PET/CT detected and localized occult disease in most men with BCR presenting with negative or equivocal conventional imaging. PyL-PET/CT led to changed management plans in the majority of pts, thus providing evidence that clinicians find PSMA PET imaging useful in men with recurrent or suspected metastatic PCa. Clinical trial information: NCT03739684 .

This article discusses the “uncoordinated” critique of the disaster recovery process and the current attempt to address the issue through the National Disaster Recovery Framework (NDRF). Scholars have identified that the topic of coordination in disaster recovery is one that needs policy attention and it is laudable that the federal government has provided such focused attention by way of the NDRF. Yet, it is also important to critically examine whether the NDRF’s proposed recovery coordination vision – the local disaster recovery manager – is a reasonable foundation upon which to address the issues of recovery processes nationwide. This article examines this issue by discussing the extent to which the NDRF recovery manager role is consistent with what the literature would suggest, the extent to which the NDRF role is needed, and the extent to which it is possible that the NDRF-depicted local role be fulfilled across the country. Implications for the vision set out in the NDRF and recommendations for future research are discussed in light of this analysis.

Nuclear magnetic resonance (NMR) spectroscopy was employed to determine the conjugated linoleic acid (CLA) content in beef muscle tissue. NMR is an inviting and greener alternative to traditional methods such as gas chromatography (GC), which can require time-consuming sample derivatization and use of large quantities of solvents. In this work, a new rapid and reliable lipid extraction protocol was combined with simple, non-destructive 1 H NMR spectroscopic analysis to measure the total CLA content in 41 Canadian beef ribeye steaks purchased in western Canada. The total CLA concentrations (mg/100 g meat) obtained using the new extraction and analysis methods were consistent with amounts found using the traditional lipid extraction and GC analysis (correlation coefficient of 0.961).

This study explored the pre-disaster integration of Community Emergency Response Teams (CERTs) within local emergency management systems through semi-structured telephone interviews with 21 CERT program coordinators. It was found that the integration of CERTs varied significantly from not integrated at all to highly integrated. This paper reports the findings related to why this variation occurred. Specifically, it was found that integration seemed to covary with the resources available to the team, the opportunity within the local emergency management system for the CERT to play a role, the team’s leadership, the formality of the team’s structure, and the acceptance of CERT within the local emergency management system.

This paper explains the perceived implementation behaviour of counties in the United States with respect to the National Incident Management System (NIMS). The system represents a massive and historic policy mandate designed to restructure, standardise and thereby unify the efforts of a wide variety of emergency management entities. Specifically, this study examined variables identified in the NIMS and policy literature that might influence the behavioural intentions and actual behaviour of counties. It found that three key factors limit or promote how counties intend to implement NIMS and how they actually implement the system: policy characteristics related to NIMS, implementer views and a measure of local capacity. One additional variable-inter-organisational characteristics-was found to influence only actual behaviour. This study's findings suggest that the purpose underlying NIMS may not be fulfilled and confirm what disaster research has long suggested: the potential for standardisation in emergency management is limited.

Objective: The objective of this study was to explore how local county emergency managers conceptualize sustainability and apply the concept within their jobs. Design: Qualitative, semistructured telephone and face-to-face interviews were used to collect data from a purposive and convenience sample of local county emergency managers. Setting: Interviews were conducted with Florida and North Dakota emergency managers. Subjects, Participants: Twenty-five local county emergency managers participated in this study. Results: The study demonstrated that there is a lack of definitional clarity in emergency manager conceptualizations of sustainability. Nevertheless, emergency managers apply the concept to their jobs in important ways. Conclusions: Emergency management has the opportunity to further define its role vis-a-vis sustainability and how it does so will have implications for the communities it serves, the professionals who will be tasked with it, and the educators who will support the development of future generations of emergency management professionals.

For decades emergency management has presented itself as an emerging profession devoted to coordinating activities related to mitigation, preparedness, response, and recovery. However, there has been little research to assess the extent to which it is, in fact, engaged in the coordination of activities in all of these areas. This study addresses this research gap by reporting the results of interviews with 54 county level emergency managers from eleven states regarding their role in disaster recovery. The results suggest that recovery is subordinate to other functional areas (e.g., preparedness, response, mitigation) within the work lives of the county emergency managers who participated in this research.

In the wake of the 11 September 2001 terrorist attacks in the United States, organizations involved in emergency management at the local, state and federal level were mandated to utilize the Incident Command System (ICS) to structure on-scene response efforts. The system is currently relied upon as an organizing mechanism for response in the United States, and its widespread use outside of the United States is being advocated. Yet, there is little evidence that the system is consistently used as designed or a salve to common response problems. This paper reviews the evolution of ICS in practice and the available research on its use and effectiveness. The review makes clear that more research on the system is urgently needed.

4108 Background: PPGL, rare neuroendocrine tumors with a 5-yr survival rate as low as 12%, have a high unmet need for effective treatment options. AZEDRA, a high-specific-activity iodine-131 meta-iodobenzylguanidine (HSA I-131-MIBG), is the first and only FDA- approved therapeutic radiopharmaceutical agent indicated for the treatment of adult and pediatric pts with iobenguane scan positive, unresectable, locally advanced or metastatic PPGL who require systemic anticancer therapy. Methods: Pts with advanced disease who were heavily pre-treated and were ineligible for curative surgery or chemotherapy received a dosimetric dose followed by up to two therapeutic doses (each at 296 MBq/kg to a max of 18.5 GBq). The primary endpoint, defined as the proportion of pts with at least 50% reduction of all antihypertensive medication(s) lasting ≥6 months, was met and previously reported. Updated secondary endpoints including overall survival (OS) and safety are reported. Results: A dosimetric dose of HSA I-131-MIBG was administered to 74 pts. Of those, 68 pts received one therapeutic dose and 50 received two doses of HSA I-131-MIBG. Clinical benefit rates (objective tumor responses defined by RECIST 1.0 and stable disease) were observed in 71.4% and 98.0% of pts receiving one and two therapeutic doses, respectively. As of Jan 25, 2019, median OS for all pts was 41.1 months (95% CI 31.1, 91.2). Median OS was 17.5 months (95% CI 4.0, 31.5) and 48.7 months (95% CI 33.2, 91.2) in pts receiving one and two doses, respectively. A tail of survival was observed, with OS of 73.1% at 2 yrs and 44.2% at 4 yrs. The most common (≥50%) adverse events were nausea, fatigue, and myelosuppression. Myelosuppressive events resolved within 4-8 wks without requiring stem cell transplantation. Late radiation toxicity included 8 pts with secondary malignancies (myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), colon cancer, and lung carcinoma) of which MDS, ALL and AML were considered related to I-131 radiotherapy. Conclusions: Updated results from this pivotal phase 2 study suggest that HSA I-131-MIBG is an efficacious and safe treatment for advanced PPGL. Clinical trial information: NCT00874614.

TPS5093 Background: Early and accurate detection of recurrent or metastatic prostate cancer remains an unmet diagnostic need for patient management. While agents for positron emission tomography (PET), such as 11C-choline and 18F-fluciclovine, have emerged as options for imaging recurrent prostate cancer, these agents are not specific for the disease. 18F-DCFPyL is a novel, low-molecular weight, PET radiopharmaceutical that binds selectively to prostate-specific membrane antigen with high affinity. In prior studies, 18F-DCFPyL PET/CT has shown reliable diagnostic performance in detecting metastatic or recurrent prostate cancer (Rowe Mol Imaging Biol 2016 18:411-19; Gorin J Urol 2018 1999:126-32). Methods: CONDOR is a phase 3, multicenter, open-label study designed to assess the diagnostic performance and clinical impact of 18F-DCFPyL PET/CT in men with suspected recurrent or metastatic prostate cancer. Approximately 200 patients are planned to be enrolled across 15 centers in the United States and Canada. Eligible patients ≥18 years of age must have histologically confirmed prostate adenocarcinoma, have rising PSA after definitive therapy, and negative or equivocal conventional imaging. A single 9 mCi (333 MBq) dose of 18F-DCFPyL is administered, followed by whole body PET/CT scan 1 hour later. The primary objective is to assess the correct localization rate (percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and the composite truth standard, defined as either evaluable histopathology, informative correlative imaging, or PSA response after radiation therapy). Additional study objectives include safety and tolerability of 18F-DCFPyL, impact on intended treatment plans, detection rates and PPV of 18F-DCFPyL by region, and detection rates by baseline PSA. 18F-DCFPyL PET/CT results are centrally reviewed by independent readers blinded to all clinical and other imaging information. As of February 9, 2019, a total of 36 patients have been dosed in the study. Clinical trial information: NCT03739684.

5012 Background: Accurate detection of prostate cancer is imperative to patient management, yet standard imaging methods perform poorly in accurately detecting mPC. 18F-DCFPyL is a novel PET imaging agent that selectively binds to prostate-specific membrane antigen, a recognized target for prostate cancer. OSPREY was a prospective, multicenter study in pts with either newly diagnosed high-risk prostate cancer (cohort A), or known or suspected mPC (cohort B). Here we focus on Cohort B. Methods: 117 men planned for biopsy of recurrent or mPC received 18F-DCFPyL. Pts underwent image-guided biopsy. Sensitivity, positive predictive value (PPV), and safety of 18F-DCFPyL PET/CT were the key endpoints for Cohort B. 18F-DCFPyL PET/CT scans were evaluated by three independent, blinded central readers; and results were compared to histopathology as the truth standard. Results: The sensitivity and PPV of 18F-DCFPyL PET/CT as compared to histopathology ranged from 92.9-98.6% (lower bound of 95% CI: 84.0-91.6%) and 81.2-87.8%, respectively. Diagnostic performance by anatomic location showed high sensitivity and high PPV in all sites of disease (Table). Only two (1.7%) cohort B pts experienced ≥1 drug-related AE (dysgeusia and generalized rash), both were mild (Grade 1) in severity. Conclusions: 18F-DCFPyL PET/CT was well tolerated and demonstrated high sensitivity and PPV in accurately detecting nodal, bone, and visceral/soft tissue metastases. A positive 18F-DCFPyL PET/CT scan is highly likely to represent pathologically proven distant disease, demonstrating the potential of 18F-DCFPyL as a PET imaging agent to favorably influence treatment planning. Clinical trial information: NCT02981368. [Table: see text]

388 Background: Iobenguane scan positive cancers include pheochromocytoma and paraganglioma (PPGL), neuroblastoma, and gastroenteropancreatic neuroendocrine tumors. A pooled analysis was conducted to assess the safety profile of high-specific-activity I-131 metaiodobenzylguanidine (HSA I-131 MIBG [AZEDRA]) in PPGL and neuroblastoma. Methods: Safety data were pooled from four clinical studies with 118 subjects who received HSA I-131 MIBG. Adverse events (AEs) were described by age, gender, race, number of HSA I-131 MIBG doses, temporal association of AEs within 12 weeks after therapeutic dose 1, vital signs, laboratory values, hematological events of Grade 3/4 or serious AEs, and changes in mean hematology values over a period of 12 months. Results: Out of 118 subjects, mean age was 47.0 ± 18.9 years (range 3-76); 57.6% were males and 74.6% were white. A total of 102 (86.4%) subjects had at least one AE assessed as treatment-related. The incidences of most AEs were similar among both genders and all racial groups. The most common toxicities associated with HSA I-131 MIBG were gastrointestinal disorders, with nausea the most prevalent. The incidences of nausea and salivary gland pain showed decreasing trends with age while dyspnea, asthenia, and peripheral edema showed increasing trends. The second most common toxicities were hematologic. Following each therapeutic dose, mean hemoglobin, leukocytes, neutrophils, and platelets decreased. Most hematological AEs resolved within 12 weeks, and recovery to pre-therapeutic dose values was apparent 6 months after each therapeutic dose. After therapeutic dose 1, higher percentages of subjects experienced AEs in the first 2 weeks, and the incidence decreased beyond 6 weeks. No notable changes were observed in clinical chemistry tests. The incidence of Grade 3/4 AEs was similar following each therapeutic dose. Conclusions: HSA I-131 MIBG was safe and well-tolerated among subjects with iobenguane scan positive cancers. No trends were discerned between baseline characteristics and AEs. Hematology results reflected toxicity profile expected in a population of subjects administered a radiopharmaceutical. Clinical trial information: Pooled Safety.

Introduction. In 2011, following heavy winter snowfall, two cities bordering two rivers in North Dakota, USA faced major flood threats. Flooding was foreseeable and predictable although the extent of risk was uncertain. One community, Fargo, situated in a shallow river basin, successfully mitigated and prevented flooding. For the other community, Minot, located in a deep river valley, prevention was not possible and downtown businesses and one-quarter of the homes were inundated, in the city’s worst flood on record. We aimed at contrasting the respective hazards, vulnerabilities, stressors, psychological risk factors, psychosocial consequences, and disaster risk reduction strategies under conditions where flood prevention was, and was not, possible.Methods. We applied the “trauma signature analysis” (TSIG) approach to compare the hazard profiles, identify salient disaster stressors, document the key components of disaster risk reduction response, and examine indicators of community resilience.Results. Two...

4005Background: AZEDRA, a high-specific-activity iodine-131 meta-iodobenzylguanidine (HSA I-131 MIBG), has been developed for the treatment of iobenguane-avid malignant (metastatic) or recurrent or...

TPS5092Background: Accurate localization of sites of disease is essential for delivering optimal care to patients with prostate cancer. This is especially true for patients who may have distant dis...

Research was conducted on how rural emergency managers at the local level understand and employ the National Incident Management System in 2007. This article focuses on research findings from face-to-face interviews with county emergency managers in three states. The data revealed that the majority of emergency managers interviewed interpret NIMS in a generally positive manner; however, they do so with considerable qualification. Emergency managers recognized that their interpretation of NIMS plays a role in how they comply with and implement NIMS; however, it was discovered that it is not the emergency managers’ interpretation that determines compliance and implementation as much as it is factors related to local reality. The unique amalgamation of emergency manager interpretations and local reality produced large variation in NIMS compliance and implementation—no two emergency managers and no two counties were exactly alike. Therefore, though the federal government mandated its expectations and standards for emergency management through NIMS, both people and aspects of place dictate the mandate's interpretation and implementation. Based on findings from the research, implications of findings for emergency management are discussed and suggestions are made for future research.