A Real-World Evidence Study Using Alberta-Population-Based Data to Describe Treatment Patterns for Metastatic Castration-Sensitive Prostate Cancer Patients (AWARENESS).

Real-world Evidence on Baseline Characteristics and Treatment in Metastatic Hormone-sensitive Prostate Cancer: Findings from the PIONEER 2.0 Big Data Investigation Group

Studies have investigated the effects of androgen deprivation therapy (ADT) use on the incidence and clinical outcomes of coronavirus disease 2019 (COVID-19); however, the results have been inconsistent. We searched the PubMed, Medline, Cochrane, Scopus, and Web of Science databases from inception to March 2022; 13 studies covering 84 003 prostate cancer (PCa) patients with or without ADT met the eligibility criteria and were included in the meta-analysis. We calculated the pooled risk ratios (RRs) with 95% confidence intervals (CIs) to explore the association between ADT use and the infection risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and severity of COVID-19. After synthesizing the evidence, the pooled RR in the SARS-CoV-2 positive group was equal to 1.17, and the SARS-CoV-2 positive risk in PCa patients using ADT was not significantly different from that in those not using ADT (P = 0.544). Moreover, no significant results concerning the beneficial effect of ADT on the rate of intensive care unit admission (RR = 1.04, P = 0.872) or death risk (RR = 1.23, P = 0.53) were found. However, PCa patients with a history of ADT use had a markedly higher COVID-19 hospitalization rate (RR = 1.31, P = 0.015) than those with no history of ADT use. These findings indicate that ADT use by PCa patients is associated with a high risk of hospitalization during infection with SARS-CoV-2. A large number of high quality studies are needed to confirm these results.

5072 Background: Over the past 6 years, intensification of androgen deprivation therapy (ADT) with docetaxel (DOC) and novel hormonal therapies (NHT) [abiraterone, enzalutamide, and apalutamide], has been shown to improve survival outcomes in men with mCSPC. This study assessed the real-world utilization of effective combination therapies as 1L treatment in insured pts in the U.S. with mCSPC. Methods: This retrospective study used the Optum health insurance claims database, which includes pt claims data from both commercially insured and Medicare Advantage populations. Eligible pts were adult men with ≥1 claim with a metastatic International Classification of Diseases diagnostic code (first claim was index date) within 90 days (d) prior to, or any time after, a prostate cancer diagnosis between January 2014 and June 2019. Pts with evidence of systemic anticancer therapy during the 1-year pre-index baseline period were excluded, unless the first drug claim occurred within 90 d prior to the diagnosis of metastatic disease. The 1L treatments were identified as any treatment for mCSPC within 90 d pre-index, plus any other treatment received within 180 d of the first, and were grouped by regimen: ADT only; ADT + first-generation antiandrogens (AA); ADT + DOC; ADT + NHT; and ADT + NHT + DOC. Results: Of 4221 men with mCSPC, 2364 (56.0%) received ADT only; 892 (21.1%) ADT + AA; 577 (13.7%) ADT + NHT; 348 (8.2%) ADT + DOC; and 40 (0.9%) ADT + NHT + DOC. Pts who received ADT + DOC or ADT + DOC + NHT were generally younger than the other treatment groups (Table). By 2019, use of ADT only and ADT + AA had declined, while the use of ADT + NHT and ADT + NHT + DOC had increased (Table). However, in 2018 and 2019, the majority of men with mCSPC still received either ADT alone, or ADT + AA, including those with visceral metastases (Table). Survival analysis across treatment cohorts is ongoing. Conclusions: Despite level 1 evidence demonstrating improved survival with intensified treatment (ADT + DOC or NHT), this study shows its underutilization in pts with mCSPC. This is evident even in those with more aggressive disease (visceral metastases) as recently as 2019. These data highlight that a minority of pts with mCSPC received optimal life-prolonging therapies in a commercially insured and Medicare Advantage U.S. population. Further studies are needed to identify the reasons for this underutilization of intensified treatments.[Table: see text]

Treatments for Metastatic Hormone-sensitive Prostate Cancer: Systematic Review, Network Meta-analysis, and Benefit-harm assessment

5067 Background: Previous studies suggested that androgen deprivation therapy (ADT) may reduce severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infectivity. However, it is unknown whether there is an association between ADT and a higher survival in prostate cancer patients with COVID-19. Methods: We performed a retrospective analysis of prostate cancer (PC) patients hospitalized to treat COVID-19 in Brazil’s public health system. We compared patients with the active use of ADT versus those with non-active ADT, past use. We constructed propensity score models of patients in active versus non-active use of ADT. All variables were used to derive propensity score estimation, and for the outcome analysis we performed a multivariate backward elimination process to select variables to add to the propensity score model. Results: We analyzed 109 PC patients with COVID-19 that presented past or current use of ADT. In total, 52.8% of our patients were less than 75 years old, 44.0% (48/109) were in active ADT, and most were using a GnRH analog (73%, 35/48). Also, 63.3% of our cohort died from COVID-19. ADT active use were protective factor in our logistic regression model (OR 0.28, 95% CI 0.12–0.66, P = 0.0036). We noticed a significant imbalance in the propensity score of patients in active and those in non-active ADT. Then, when we performed a propensity score-based inverse weight double robust estimation model, we observed that ADT remained statistically associated with improved overall survival (average treatment effect [ATE] -0.26, 95% CI -0.45 to -0.08, P = 0.0058). Conclusions: The active use of ADT was associated with a reduced risk of death in patients with COVID-19.

e15093 Background: Androgen Deprivation Therapy (ADT) is commonly used in the treatment of prostate cancer. However, little is known about patients' information needs regarding ADT. This area is important as it may directly impact on patients' clinical care, adherence to therapy, and satisfaction with treatment. Methods: A cross-sectional survey was distributed to 83 patients who visited the prostate clinic at the Princess Margaret Hospital, Toronto, Ontario. Eligible men included those who spoke English and were on ADT adjuvant to radiation therapy or radical prostatectomy or for biochemical relapse. Three cohorts of men were recruited based on duration of ADT use: men who were on ADT for < 6 months (n=22), between 6 to 18 months (n=25), and 18 months to 4 years (n=36). For patients on adjuvant ADT, patients' quantitative perceptions of their own prognosis with and without ADT were obtained by eliciting survival probabilities at 5-, 10-, and 15-years. Patients' reported understanding of side effects with ADT was analyzed using thematic analyses. Patients on ADT for <6 months were asked about education by their physician at the time of ADT initiation. Analyses were primarily descriptive for the overall cohort and based on duration of ADT use. Results: Mean patient age was 70.5 years (range 46-85). The mean perceived/reported increase in survival with ADT was 5.0%, 8.5%, and 9.9% at 5, 10, and 15-year intervals. Hot flashes were the most reported side effect of ADT in all three cohorts (59%-81%). Other cited side effects included decreased libido, fatigue, and weight gain. 27.2% of patients in cohort 1 felt that their physician spent too little time discussing ADT and 54.5% felt that they were only able to ask half or less of the questions they had about ADT. The vast majority of patients believed that receiving written information on ADT would be helpful both before and after the initiation of ADT (97.6% and 96.4%, respectively, in all patients). Conclusions: Hot flashes are the most common side effect for patients on ADT. Information needs of patients on ADT can be better addressed by allocating more time at the initial patient visit, discussing side effect profiles during follow-up visits, as well as making written information available in the clinic at initial and subsequent visits. No significant financial relationships to disclose.

The objective of this study was to investigate the impact of the biologically equivalent dose (BED) on treatment outcomes after iodine‐125 low‐dose‐rate brachytherapy (LDR‐BT) with or without supplemental external beam radiotherapy (EBRT) and androgen deprivation therapy (ADT) for intermediate‐risk prostate cancer (PCa). We retrospectively evaluated 292 Japanese patients. The impact of the BED and ADT on treatment outcomes was investigated. Cox proportional hazard models were used for univariate and multivariate analysis with biological progression‐free survival (bPFS) and clinical progression‐free survival (cPFS) as the primary outcome measures. The median follow‐up was 66 months. The bPFS and cPFS rates at 5‐/7‐years were 91.6/87.7% and 95.9/94.0%, respectively. When stratified by BED levels, the bPFS rates at 5‐/7‐years were 92.1/89.3% for <178.0 Gy2, and 91.2/86.0% for ≥178.0 Gy2, respectively (P > 0.05). Based on ADT duration, the bPFS rates at 5‐/7‐years were 89.8/83.5%, 89.7/89.7%, and 97.5/97.5% for none, 1–3 months, and 4–12 months, respectively (P = 0.03). For the univariate analysis, the use of ADT and its duration were significant predictors for bPFS, whereas BED was not significant. A multivariate analysis did not indicate the use of ADT itself was significant, however, when covariates were accounted for by the duration of ADT, the longer use of ADT was found to significantly improve bPFS. Although cPFS was associated neither with the BED levels nor ADT duration (P > 0.05), ADT duration had a trend of improving cPFS (P = 0.053). The higher levels of BED did not significantly impact bPFS for intermediate‐risk PCa after LDR‐BT with or without supplemental EBRT and ADT. The longer duration of ADT could provide an additional benefit in the context of high‐dose irradiation generated by LDR‐BT.

Stroke and Thromboembolic Events in Men with Prostate Cancer Treated with Definitive Radiation Therapy with or without Androgen Deprivation Therapy

The Effect of Androgen Deprivation Therapy on Periodontal Disease in Men With Prostate Cancer

Persistent Testosterone Suppression After Cessation of Androgen Deprivation Therapy for Localized Prostate Cancer

Androgen deprivation therapy (ADT), either by surgical or chemical castration, is the standard treatment for metastatic prostate cancer (PCa). ADT induces osteoporosis and increases the risk of osteoporotic fractures, such as hip fractures. However, the effect of castration on overall survival (OS) after hip fracture is unclear. The aim of this study was to evaluate the association between ADT and OS among PCa patients with surgically treated low-energy hip fractures. Male patients with surgically treated low-energy hip fractures (ICD-10 codes S72.0, S72.1, and S72.2) were retrospectively identified from the databases of Pirkanmaa Hospital District during the years 2002-2018. Patients with pathological hip fractures were excluded from the analysis. Patients with prior PCa were identified (n = 323) and categorized into three groups according to therapy that affects testosterone levels: no hormonal therapy (n = 94), ADT (n = 212), and nonsteroidal antiandrogen (NSAA) (n = 17) at the time of the fracture. The primary outcome was OS after hip fracture surgery. Postoperative OS was analyzed using the Kaplan-Meier method, and the difference in OS between groups was analyzed using Cox regression in univariable, age-adjusted, and multivariable-adjusted models. Kaplan-Meier survival analysis suggested that patients under ADT had shorter OS after hip fracture surgery (p = 0.006). After adjustment for potential confounders in Cox regression models, no clear association was observed between ADT (hazard ratio (HR) 1.19, 95% confidence interval (CI) 0.90-1.58) or NSAA (HR 1.02 (0.59-1.78)) and OS when compared to patients with PCa not undergoing hormonal therapy. Higher age and comorbidities, rather than ADT, appeared to be associated with poorer OS. In the cohort of patients with PCa, who underwent surgery for low-energy hip fracture, ADT or NSAA utilization was not associated with OS. Wide CIs allow for both modest benefit and potential harm, and the findings should therefore be considered inconclusive.

Who Should Receive Androgen Deprivation Therapy?

MP11-15 REAL-WORLD EVIDENCE OF 18F-FLUCICLOVINE PET/CT UTILIZATION FOR RECURRENT PROSTATE CANCER IN THE VETERAN AFFAIRS HEALTH SYSTEM

Since its introduction more than 70 years ago, the use of androgen deprivation therapy (ADT) for prostate cancer has evolved to become part of a multimodal management approach. In this presentation from the NCCN 21st Annual Conference, James L. Mohler, MD, reviewed data that inform these strategies and gave his bottom-line recommendations on issues such as ADT plus radiotherapy, continuous versus intermittent ADT, ADT for positive nodes, and ADT plus docetaxel. He suggested that ADT plus radiation therapy should be used in patients at high risk, intermittent ADT is more appropriate for most patients than continuous ADT, and docetaxel should be given with ADT for high-volume metastatic disease.

PD37-03 ANDROGEN DEPRIVATION THERAPY AND THE INCIDENCE OF AUTOIMMUNE DISEASES IN 17,168 PATIENTS WITH PROSTATE CANCER