Abstract

e18561 Background: Prostate cancer is the second leading cause of cancer-related mortality among males in the United States after lung cancer. Among other factors, physical access to clinical trial site plays a pivotal role in the recruitment process and hence impact outcomes. We aim to study the geographical distribution of phase III and IV prostate cancer clinical trials in the United States. Methods: The United States Cancer Statistics Data Visualisation Tool was utilised to estimate the number of new cases of prostate cancer for the latest available years i.e., 2014-2018. An extensive search was carried out at ClinicalTrials.gov registry using advanced search fields – disease (prostate cancer), sex (male), study type (clinical trial), phase (III and IV), country (United States) and study start (from 01/01/2014 to12/31/2018). The trials which were terminated, withdrawn, or suspended were excluded from the study. Both these tools were further explored to provide state-wise distribution of new trials and cases. Results: Between 2014-2018 in the United States, 997, 454 new prostate cancer cases were reported and 59 phase III & IV clinical trials were made available across 51 states. The average number of new prostate cancer cases and trials per state was 19,558 and 17 (range 45-0) respectively. The states with maximum reported number of new cases were California, New York, Florida, and Texas. These accounted for 30.2% of total cases and only 15.5% of total trials. The states with least reported new cases were Alaska, Vermont, Wyoming, and North Dakota. These accounted for 0.84 % of total cases and 2% of total trials [Table]. The states with the minimum number of trials per case were Mississippi (0.00035), Texas (0.00041), Florida (0.00042), New York (0.00045) and California (0.00047) whereas the states with maximum number of trials per case were Alabama (0.2352), District of Colombia (0.0061), Alaska (0.0054) and Vermont (0.0024). Conclusions: Variation in the availability of phase III and IV clinical trials for newly diagnosed prostate cancer cases was noted across 51 states of the US during the study period from 2014-2018. The states with higher disease burden had a much lower ratio of trials available per case despite higher absolute number of clinical trials in comparison to the states with lower disease burden. This highlights the need for better geographical allocation of clinical trials in the future based on the cancer burden for efficient resource utilisation and improved healthcare delivery.[Table: see text]

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