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  string(2197) "Background

Abiraterone acetate (AA) is a steroid that is transported into cells through solute carrier organic anions (SLCOs) and may vary in the population by intracellular concentration [1].  Adverse events of special interests (AESI), particularly hypokalemia and hypomagnesemia, represent on target inhibitory effects of adrenal steroid metabolism by AA. One potential explanation for differences in variations in AESI may be due to differences in intracellular concentrations of AA in the adrenal gland, which may also correlate with intracellular concentrations of AA within tumor cells. Therefore, AESI may correlate with greater tumor concentrations of abiraterone and impact patient outcomes. In the AbiRace study, AESI were correlated with improved radiographic progression free survival (rPFS) with a trend towards improved time to PSA progression and overall survival (OS) [2]. Black men were noted to have higher rates of AESI than white men in this study.

Objective

To determine if AESI predict response to AA

Study Design

A retrospective cohort study of patients treated with AA on the COU-AA-301 and COU-AA-302 trials.

Participants

All patients treated on the COU-AA-301 and COU-AA-302 trials.

Main Outcome Measures

Frequency of AESI

Severity of AESI

Response to AA (rPFS, time to PSA progression, OS)

Statistical Analysis

To determine if treatment with abiraterone is correlated with frequency and/or severity of AESI, we will use the Wilcoxon rank sum test to check whether the frequency or severity of AESI is same between two treatment groups. To investigate if the frequency and/or severity of AESI differ by race, we will use the Wilcoxon rank sum test to check whether the frequency or severity of AESI is same between two races. Lastly, to delineate if the presence of AESI correlates with response to AA (PSA progression, rPFS, OS), we will use the logrank test to check whether each time-to-event outcome is same between patients with AESI and patients without AESI. In addition, Kaplan-Meier curves will be plotted to visually compare two groups for these time-to-event outcomes."
  ["project_brief_bg"]=>
  string(1439) "Abiraterone acetate (AA) is a steroid that is transported into cells through solute carrier organic anions (SLCOs) and may vary in the population by intracellular concentration.[1] Adverse events of special interests (AESI), particularly hypokalemia and hypomagnesemia, represent on target inhibitory effects of adrenal steroid metabolism by AA. One potential explanation for differences in variations in AESI may be due to differences in intracellular concentrations of AA in the adrenal gland, which may also correlate with intracellular concentrations of AA within tumor cells. Therefore, AESI may correlate with greater tumor concentrations of abiraterone and impact patient outcomes. In the AbiRace study, AESI were correlated with improved radiographic progression free survival (rPFS) with a trend towards improved time to PSA progression and overall survival (OS).[2] Black men were noted to have higher rates of AESI than white men in this study (34% vs 22%). We propose a retrospective analysis of the patients treated with AA in the COU-AA-301 and COU-AA-302 trials to determine if AESI predict response to AA. In addition, we would compare differences in AESI by race. This work could reveal that the presence of AESI may serve as a biomarker for response to AA, and if so, may predict which patients would benefit combination therapy to ensure disease control. This work would also further analyze differences in AESI by race."
  ["project_specific_aims"]=>
  string(295) "Aim 1: Determine if treatment with abiraterone is correlated with frequency and/or severity of AESI

Aim 2: Determine if the frequency and/or severity of AESI differ by race

Aim 3: Determine if the presence of AESI correlates with response to abiraterone (PSA progression, rPFS, OS)"
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  ["project_research_methods"]=>
  string(267) "Data source  ? COU-AA-301 and COU-AA-302 via the YODA Project

Inclusion/Exclusion Criteria

Inclusion: Patients treated in the COU-AA-301 and COU-AA-302 trials who have adverse events reported

Exclusion: As per the COU-AA-301 and COU-AA-302 trials"
  ["project_main_outcome_measure"]=>
  string(162) "Correlation between AESI and response to AA with response defined in terms of radiograph progression free survival, time to PSA progression, and overall survival."
  ["project_main_predictor_indep"]=>
  string(51) "The presence of AESI ? particularly, hypokalemia (K"
  ["project_other_variables_interest"]=>
  string(18) "Self-reported race"
  ["project_stat_analysis_plan"]=>
  string(767) "To determine if treatment with abiraterone is correlated with frequency and/or severity of AESI, we will use the Wilcoxon rank sum test to check whether the frequency or severity of AESI is same between two treatment groups. To investigate if the frequency and/or severity of AESI differ by race, we will use the Wilcoxon rank sum test to check whether the frequency or severity of AESI is same between two races. Lastly, to delineate if the presence of AESI correlates with response to AA (PSA progression, rPFS, OS), we will use the logrank test to check whether each time-to-event outcome is same between patients with AESI and patients without AESI. In addition, Kaplan-Meier curves will be plotted to visually compare two groups for these time-to-event outcomes."
  ["project_timeline"]=>
  string(260) "Project start date ? Nov 31, 2021. Analysis of the data by Jan 20, 2021. Abstract completion by Feb 17, 2022 for submission to ASCO. Manuscript drafted and submitted for publication by June 30, 2022. Data results reported back to YODA Project by June 30, 2022."
  ["project_dissemination_plan"]=>
  string(152) "Submission to ASCO 2022. Suitable journals including Journal of Clinical Oncology; Prostate Cancer and Prostatic Diseases; Clinical Genitourinary Cancer"
  ["project_bibliography"]=>
  string(548) "
1. Mostaghel EA, Eunpi C, Zhang A, et al. Association of Tissue Abiraterone Levels and SLCO Genotype with Intraprostatic Steroids and Pathologic Response in Men with High-Risk Localized Prostate Cancer Clin Cancer Res; 23(16); 4592?601. 2017 AACR.

2. George DJ, Heath EI, Sartor AO, et al. Abi Race: A prospective, multicenter study of black (B) and white (W) patients (pts) with metastatic castrate resistant prostate cancer (mCRPC) treated with abiraterone acetate and prednisone (AAP). Journal of Clinical Oncology 36, no. 18_suppl
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