Faculty Bibliography

OBJECTIVE:To evaluate the relationship between the Global Budget Revenue (GBR) model and surgical outcomes. SUMMARY BACKGROUND DATA/BACKGROUND:Medicare tested GBR in Maryland, wherein hospitals received a fixed annual revenue to cover healthcare delivery for their population. The relationship between GBR implementation and outcomes after cancer surgery is unclear. METHODS:Observational difference-in-differences analysis using 100% national Medicare data to compare changes in outcomes between GBR hospitals and matched control hospitals before (2011-2013) and after (2014-2018) policy implementation in Traditional Medicare beneficiaries undergoing cystectomy, prostatectomy, or nephrectomy for cancer. The primary outcome was achievement of a textbook outcome, defined as the absence of in-hospital and 30-day mortality, postoperative complications, a prolonged length of stay (i.e., above the 75th percentile by procedure and year) and readmission within 30 days of discharge. The secondary outcome was Medicare inpatient spending. RESULTS:This study included 23 Maryland hospitals with 4,910 beneficiaries and 371 control hospitals with 57,456 beneficiaries. Textbook outcomes increased from 72.8% to 76.1% in GBR hospitals and from 70.2% to 70.5% in matched controls, a differential increase of 2.9 percentage points (95% CI, 0.5 to 5.3; P=0.02). The greater improvement at GBR hospitals was a result of reducing complications (-1.5 percentage points; 95% CI, -2.9 to -0.1) and limiting prolonged lengths of stay (-1.8 percentage points; 95% CI, -2.9 to -0.7). Medicare inpatient spending declined by $771 (95% CI, -$1,275 to -$267) more at GBR hospitals. CONCLUSIONS:The GBR was associated with improved surgical outcomes and lower Medicare inpatient spending.

PURPOSE/UNASSIGNED:Recent publications have renewed interest in prophylactic pelvic radiation therapy for higher-risk prostate cancer, as well as dose escalation for magnetic resonance imaging (MRI)-defined intraprostatic lesions. Here, we explore the use of pelvic nodal irradiation with a 3-fraction stereotactic body radiation therapy (SBRT) boost to the prostate and seminal vesicles, with a simultaneous MRI-directed focal intraprostatic lesion-ablative microboost (MIB). METHODS AND MATERIALS/UNASSIGNED:We evaluated an institutional registry of patients undergoing pelvic nodal radiation followed by an SBRT boost to the prostate and seminal vesicles from April 2021 to March 2023. The study was approved by the local institutional review board (study #00001269). All patients were treated with pelvic nodal irradiation followed by a 3-fraction SBRT boost. The prostate SBRT boost dose was primarily 2100 cGy in 3 fractions (an accommodated range of 1800-2100 cGy). A subgroup of 15 patients received an MIB to an additional dose of 2300 cGy in 3 fractions (range, 2100-2400 cGy). The distribution of adverse event grades for acute and late gastrointestinal (GI) and genitourinary (GU) toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. RESULTS/UNASSIGNED:Fifty-eight patients underwent pelvic nodal irradiation followed by an SBRT boost to the prostate, with the distribution of risk groups as follows: patients were either in the high (36.2%, n = 21) or very high (34.5% n = 20) risk groups, whereas those with known nodal disease (19.0%, n = 11) or intermediate risk (10.3%, n = 6) comprised the rest of the study population. Most patients received androgen-deprivation therapy. The prostate SBRT boost dose was primarily 2100 cGy in 3 fractions. Fifteen patients received an MIB to an additional dose of 2300 cGy in 3 fractions. A median follow-up of 8.7 months was used to document the incidence of GU and GI toxicity. The distribution of GI and GU toxicity showed no significant difference between the MIB and non-MIB subcohorts at either the acute (<90 days) or late (>90 days) time points. Two grade 3 toxicities were observed, both in the non-MIB cohort. Grade 2+ GI and GU toxicities were not significantly different between the 2 groups, as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. CONCLUSIONS/UNASSIGNED:In the early follow-up period, we observed no significant difference in GI or GU toxicity between those who underwent MIB and those who did not. These results suggest that MRI-directed SBRT MIB did not increase GI toxicity and may even reduce GU toxicity compared with standard treatment. Future research should explore long-term side effects, with attention to the Expanded Prostate Cancer Index Composite (EPIC) scores and oncologic outcomes of this novel method of dose escalation.

PURPOSE/OBJECTIVE:Both MRI and PSMA PET/CT are often utilized for staging of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). Recent studies found that PSMA PET/CT was superior to MRI in correctly identifying final pathological tumor stage, dominant nodule, extraprostatic extension (EPE), and small areas of clinically significant PCa. We sought to determine if PSMA PET/CT was superior to MRI in both locoregional staging of PCa and potential focal therapy planning. METHODS:We retrospectively analyzed our prospectively collected, IRB-approved database of all patients who underwent prostatectomy at one institution between 10/1/2019-2/29/2024. Patients were excluded if they did not pre-operatively undergo both MRI and PSMA PET/CT. 2 × 2 tables were used to compare each modality to the "gold standard" of prostatectomy specimen in both the proper detection of laterality and presence of EPE. Sensitivities and specificities were compared using a chi-squared test. HR v. IR groups were compared using a Wilcoxon rank sum test for continuous variables and Fisher's exact test for categorical variables. Results were considered significant at p < 0.05. RESULTS:580 patients underwent prostatectomy within the specified timeframe. 78 patients met inclusion criteria. MRI was more sensitive in the detection of EPE than PSMA PET/CT (23.5% v. 7.8%, p = 0.0294). MRI and PSMA PET/CT were similar in the specificity of EPE detection. In the identification of laterality, MRI was more specific (86.7% v. 56.7%, p = 0.0099), while sensitivities were similar between the modalities. CONCLUSIONS:MRI was superior to PSMA PET/CT in the proper detection of both EPE and laterality in patients with IR and HR PCa.

PURPOSE/OBJECTIVE:Pelvic nodal irradiation is often used for high-risk prostate adenocarcinoma. A commonly used alternative to low dose rate (LDR) brachytherapy, a 3-fraction SBRT boost with fiducial tracking may allow for better coverage of extracapsular extension and macroscopic seminal vesicle invasion. This study evaluates the practical impact of prior pelvic nodal irradiation on fiducial tracking during a subsequent 3-fraction robotic stereotactic body radiation therapy (SBRT) boost for high-risk prostate cancer and compares these outcomes to a cohort of patients undergoing definitive 5-fraction SBRT. METHODS:In this institutional analysis, we prospectively collected fiducial tracking data for patients receiving a 3-fraction boost to the prostate and seminal vesicles after conventional nodal radiation. We also identified patients treated with 5-fraction SBRT with a low risk of nodal involvement. Monte Carlo estimates of the Fisher's Exact Test assessed fiducial tracking loss. Continuous variables within the 5- and 3-fraction cohorts were compared using the Mann-Whitney Test. Changes in fiducial tracking and their association with pre-treatment factors were analyzed through the Kruskal-Wallis test and Monte Carlo for tracking patterns, and Spearman Correlation Coefficient and Mann-Whitney Test for deviations in tracking over 5 fractions. RESULTS:A total of 405 patients were treated from April 2021 to September 2023 with: (1) 5-fraction SBRT (n = 309, 76%), and (2) 3-fraction boost after nodal irradiation (n = 96, 24%). There was no significant fiducial tracking loss over the three-fraction boost treatment regimen that proceeded nodal treatment (p = 0.63). However, there was a significant (p < 0.001) loss of fiducial tracking fidelity as demonstrated by progressive loss of one tracked fiducial over 5-fractions. There was significantly more volatility observed in the 5-fraction versus 3-fraction boost treatment (median volatility 2.4 vs. 0.0, p < 0.001). There were no significant associations between fiducial tracking, independently for 3- or 5-fractions, using either analysis method or volatility for ADT, time from fiducial placement to SBRT, CTV, and QOD vs. daily SBRT. CONCLUSIONS:Pelvic nodal treatment does not affect the quantity/quality of fiducial tracking in 3-fraction treatments. However, 5-fraction treatments showed a progressive loss and increased volatility in fiducial tracking over time. No pre-treatment factors significantly influenced fiducial tracking changes in either cohort, though ADT use trended towards increased volatility in the 5-fraction group. With a minimum of 4 fiducials placed for treatment, the loss/volatility of a single fiducial had no clinical impact on the tracking system.

INTRODUCTION/BACKGROUND:High-volume (≥ 50 %) biopsy core involvement (HVCI) is an independent risk factor for unfavorable intermediate-risk prostate cancer by NCCN guidelines. The studies demonstrating increased recurrence in high-volume disease were conducted in an era of conventional fractionation, often without dose-escalation. In the SBRT era, we explore the value of this pathologic criteria in intermediate-risk disease. METHODS:A large institutional database was reviewed to identify patients diagnosed with localized intermediate-risk (Gleason Grade [GG] 2 and 3) disease, who were treated with definitive five-fraction SBRT without ADT. HVCI was analyzed (1) traditionally with all positive cores given equal weight as well as weighted with a positive core of GG1 to GG3 given (2) linearly and (3) exponentially increased weight. Oncologic outcomes were analyzed using Cox and linear regression analysis. RESULTS:From 2009 to 2018, 888 patients with intermediate-risk prostate cancer were treated with five-fraction SBRT monotherapy to a median dose of 3500 cGy. The majority (68 %) had GG2 disease. HVCI was present in the 22 % and was inversely related to prostate volume and directly related to T-stage. Biochemical disease-free survival (BDFS) was not significantly associated with HVCI in the cohort (p = 0.47) nor in the GG2 (p = 0.85) and GG3 (p = 0.26) sub-cohorts. Similarly, when linear or exponential weight was given to a core with higher-grade disease, there was no association with BDFS. Finally, PSA nadir was not associated with HVCI; however, time to PSA nadir (TTN) was negatively associated with HVCI in the GG3 sub-cohort (p = 0.04). CONCLUSION/CONCLUSIONS:With a median follow-up of 4.1 years, HVCI was not associated with BDFS following SBRT monotherapy, particularly in patients with otherwise favorable intermediate-risk disease (GG2). TTN analysis suggests that HVCI may remain prognostic in GG3 disease (by definition unfavorable intermediate-risk). Further work should prospectively confirm whether HVCI is unnecessary in risk-stratifying GG2 disease in the SBRT era.

BACKGROUND/UNASSIGNED:Phosphodiesterase type 5 (PDE5) inhibitors are used to treat erectile dysfunction, but their cost can limit access. AIM/UNASSIGNED:This study examines PDE5 inhibitors pricing and demographic data across rural and urban New York State (NYS) counties, as well as small, large, and online pharmacies. METHODS/UNASSIGNED:-tests, Wilcoxon rank-sum, and Kruskal-Wallis tests were performed using R Version 4.4.1 (2024-06-14). OUTCOMES/UNASSIGNED:The cash price of the PDE5 inhibitors across various pharmacy chain types and county types. RESULTS/UNASSIGNED: = .177). CLINICAL TRANSLATION/UNASSIGNED:This study aims to highlight the pricing variability of PDE5 inhibitors to help patients identify cost-effective options to circumvent potential financial barriers. STRENGTHS AND LIMITATIONS/UNASSIGNED:This study was the first to examine PDE5 inhibitors pricing specifically within rural populations while also providing a comparative analysis of pricing differences between small and large pharmacy chains serving these communities. The study's limitations include a relatively small sample size of rural and small chain pharmacies resulting in power levels of 75% and 69%, respectively, which may impact the generalizability of the findings. CONCLUSION/UNASSIGNED:Enhancing drug price transparency for PDE5 inhibitors is vital for increasing access and pricing flexibility.

OBJECTIVES/UNASSIGNED:To evaluate the incidence and degree of rectal wall infiltration (RWI) of spacer gel used during prostate radiotherapy among two practitioners experienced in using rectal spacers. MATERIALS AND METHODS/UNASSIGNED:Consecutive patients with prostate cancer who received prostate radiotherapy after hydrogel rectal spacer insertion in August 2023-August 2024 by two experienced practitioners were retrospectively included. Post-implant magnetic resonance imaging examinations were evaluated by two radiologists for RWI: 0 (no abnormality), 1 (rectal wall edema), 2 (superficial RWI), and 3 (deep RWI). Scores 2-3 were considered positive for RWI and their location and degree of RWI (radial, longitudinal, and circumferential) were also categorized. Inter-reader agreement was assessed with Cohen's Kappa. RESULTS/UNASSIGNED:215 men were included. Agreement was substantial between the radiologists for RWI scores (Kappa, 0.697; 95% confidence interval, 0.594-0.800). RWI scores were 0 in 80.5% (173/215), 1 in 7.9% (17/215), 2 in 10.7% (23/215), and, 3 in 0.9% (2/215) of the men. Altogether, RWI was present (scores 2-3) in 11.6% (25/215), most commonly in the mid-gland and apex with median radial, longitudinal, and circumferential involvement of 3.2 mm, 8.6 mm, and 11.5%. None of these patients demonstrated any significant rectal toxicity. CONCLUSION/UNASSIGNED:RWI was very uncommon for experienced practitioners. The degree of RWI was focal and not associated with increased complications.

BACKGROUND:to date, no standardized, evidence-based follow-up schemes exist for the monitoring of patients who underwent focal therapy (FT) and expert centers rely mainly on their own experience and/or institutional protocols. We aimed to perform a comprehensive review of the most advantageous follow-up strategies and their rationale after FT for prostate cancer (PCa). METHODS:a narrative review of the literature was conducted to investigate different follow-up protocols of FT for PCa. Outcomes of interest were post-ablation oncological and functional outcomes and complications. RESULTS:Oncological success after FT was generally defined as the biopsy-confirmed absence of clinically significant PCa in the treated zone. De novo PCa in the untreated area usually reflects an inaccurate patient selection and should be treated as primary PCa. During follow-up, oncological outcomes should be evaluated with periodic PSA, multiparametric MRI and prostate biopsy. The use of PSA derivatives and new biomarkers is still controversial and therefore not recommended. The first MRI after FT should be performed between 6-12 months to avoid ablation-related artifacts and diagnostic delay in case of FT failure. Other imaging modalities, such as PSMA PET/CT scan, are promising but still need to be validated in the post-FT setting. A 12-month "for-protocol" prostate biopsy, including targeted and systematic biopsy, was generally considered the preferred biopsy method to rule out tumor persistence/recurrence. Subsequent mpMRIs and biopsies should follow a risk-adapted approach depending on the clinical scenario. Functional outcomes should be periodically assessed using validated questionnaires within the first year, when typically recover to a new baseline. Complications, despite uncommon, should be strictly monitored mainly in the first month. CONCLUSIONS:FT follow-up is a multifaceted process involving clinical, radiological, and histological assessment. Studies evaluating the impact of different follow-up strategies and ideal timings are needed to produce standardized protocols following FT.

Androgen deprivation therapy (ADT) is a mainstay treatment for metastatic prostate cancer, improving progression-free survival. ADT suppresses the production of testosterone and reduces circulating levels of the hormone. Luteinizing hormone-releasing hormone (LH-RH) agonists are the most commonly used ADT modality. They can be given alone or in combination with androgen synthesis inhibitors or androgen receptor antagonists. An estimated 40% of prostate cancer patients will receive ADT as part of their therapy during their lifetime. However, ADT has numerous adverse effects, including an increased cardiovascular risk that impacts quality of life. Relugolix is an alternative form of ADT. It is the only oral gonadotropin-releasing hormone antagonist, circumventing injection site reactions, making it easier for patients to take, and thus increasing compliance. Testosterone suppression with relugolix is excellent and testosterone recovery after discontinuation is rapid. This paper reviews the ADT and anti-androgen treatment options for men with prostate cancer and the cardiovascular effects of these therapies. There is accumulating evidence that cardiovascular risk with relugolix is lower than with other ADT medications and also lower than with androgen synthesis inhibitors and androgen receptor antagonists. This paper provides insight into the use of different ADT regimens based on the cardiovascular status and circumstances. It explores strategies to mitigate negative cardiovascular consequences and highlights the need for further study.