Patient Demographics and Major Adverse Cardiovascular Events after Androgen Deprivation Therapy for Prostate Cancer.

Background: The association between patient demographics and CV events after ADT using real-world data was evaluated. In addition to encompassing >30 times more patients than all previous MACE studies, this is the first study, to the best of our knowledge, to include a comprehensive listing of many demographic factors from one large, recent US dataset over a long period of time.

Materials And Methods: The retrospective analysis of data in the Decision Resources Group (now Clarivate) Real World Evidence repository, representing >300M US patients from 1991 to 2020 across all US regions, was performed.

Subcutaneous in situ gel delivered leuprolide acetate's consistent and prolonged drug delivery maintains effective testosterone suppression independent of age and weight in men with prostate cancer.

Objectives: To assess the impact of patient age and weight on the pharmacokinetics (PK), testosterone (T) suppression and safety from four fixed dosing regimens (7.5, 22.5, 30, or 45 mg for 1-, 3-, 4-, or 6-months, respectively) of subcutaneous in situ gel delivered leuprolide acetate (Gel-LA) injected via the ATRIGEL Delivery System in patients with prostate cancer (PCa).

The Impact of Late Luteinizing Hormone-Releasing Hormone Agonist Dosing on Testosterone Suppression in Patients with Prostate Cancer: An Analysis of United States Clinical Data.

Purpose: We evaluated the timeliness of androgen deprivation therapy dosing, the impact of dosing nonadherence on testosterone, and the frequency of testosterone and prostate specific antigen testing in patients with prostate cancer.

Materials And Methods: We retrospectively analyzed the records of 22,860 patients with prostate cancer treated with luteinizing hormone-releasing hormone agonists. Analyses were done using 2 definitions of month, including a 28-day month (late dosing after day 28, 84, 112 or 168) and an extended month (late after day 32, 97, 128 or 194) for 1, 3, 4 and 6-month formulations, respectively.

Effectiveness of Subcutaneously Administered Leuprolide Acetate to Achieve Low Nadir Testosterone in Prostate Cancer Patients.

Evidence suggests lower nadir testosterone levels during the first year of androgen deprivation therapy improve advanced prostate cancer clinical outcomes. We evaluated pivotal trials for subcutaneously administered leuprolide acetate (1-, 3-, 4-, and 6-month doses) to determine nadir testosterone levels. Pooled analysis showed 99%, 97%, and 91% of patients reached nadir testosterone ≤20, ≤10, and ≤5 ng/dL respectively (median ≤3 ng/dL).

Cell-based high-throughput screening assay system for monitoring G protein-coupled receptor activation using beta-galactosidase enzyme complementation technology.

A novel cell-based functional assay to directly monitor G protein-coupled receptor (GPCR) activation in a high-throughput format, based on a common GPCR regulation mechanism, the interaction between beta-arrestin and ligand-activated GPCR, is described. A protein-protein interaction technology, the InteraX trade mark system, uses a pair of inactive beta-galactosidase (beta-gal) deletion mutants as fusion partners to the protein targets of interest. To monitor GPCR activation, stable cell lines expressing both GPCR- and beta-arrestin-beta-gal fusion proteins are generated.