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  ["project_date_type"]=>
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  ["property_scientific_abstract"]=>
  string(2507) "Background: Prostate cancer (PCa) is the second leading cause of male death; over 260,000 men are diagnosed and 35,000 die each year. 1 Patients receive first generation androgen deprivation therapy (ADT). PCa patients are at increased risk of therapy-related adverse events (AEs), including cardiovascular disease (CVD) outcomes. The introduction of androgen receptor targeted (ART) drugs to ADT may increase therapy-related AE and CVD risk. There is no recommendation in clinical guidelines to choose one drug over the other, and the choice of treatment options complicates clinical decision-making. This trial will offer a comparison of ABI and ENZ to improve clinician decision-making and enhance patient care. Is there a difference in outcomes according to patient type based on drug received?

Objective: To compare the safety of enzalutamide and abiraterone for mCRPC.

Study design: Individual participant data (IPD) systematic review and meta-analysis of randomized controlled trials and single-arm trials, according to PRISMA-IPD best practices. 12 Trials identified in trial repositories.

Participants: mCRPC patients

Main Outcome Measures: 1. Therapy-related adverse events 2. Time to radiographic progression or death from any cause, which ever occurred first. 3. Time to PSA progression. 4. Overall survival.

Statistical Analysis: We will conduct IPD meta-analysis utilizing a two-stage approach as discussed by Walker et al13 and espoused by the Cochrane Individual Participant Data Meta-analysis Methods Group. 14 Stage one will include a summary of each individual trial. Stage two will involve a meta-regression stratified by study type using mixed effects modeling techniques with structures that account for the relative similarity (i.e., correlation) of observations within the same study by random effects when we generalize effect estimation and inference across studies by fixed effects comparing the exposure of interest (the independent variable, abiraterone and enzalutamide). This methodology will also serve to maintain the overall structure of the individual studies, as they will not be treated as an overall aggregate and analyzed as though they were drawn from a single study and ostensibly independent and identically distributed (iid) observations. The dichotomous outcome effects will be estimated by odds ratios (OR) with 95% credible intervals (CI). The time-to-event outcome effects will be estimated by hazard ratios (HR) with 95% CI."
  ["project_brief_bg"]=>
  string(1805) "Prostate cancer (PCa) is the most common cancer and second leading cause of death among men; over 260,000 men are diagnosed yearly and nearly 35,000 will die from the disease. 1 Patients receive first generation androgen deprivation therapy (ADT). ADT blocks the secretion of testosterone and other androgens and is first-line therapy. PCa patients are at increased risk of therapy-related adverse events (TRAEs), including cardiovascular disease (CVD) outcomes. ADT works to decrease the growth of the prostate tumors by decreasing androgen. The introduction of newer agents called androgen receptor targeted (ART) drugs to ADT may further increase therapy-related AE and CVD risk. ARTs work in two ways, either by blocking the site on the tumor so it cannot receive androgens depriving the tumor of androgens or by stopping androgen production; both means decrease a tumor?s ability to grow. TRAEs vary between drugs; enzalutamide (ENZ) has increased hypertension while abiraterone (ABI) has shown increased CVD risk. 2-7 Currently, there is no clear recommendation in clinical guidelines to utilize one drug over the other, and the choice of treatment options complicates clinical decision-making. In this study, we seek to compare the safety and efficacy of alternative ARTs for mCRPC in order to inform decision-making. We will identify, appraise, and synthesize data from clinical trials of two current therapies for mCRPC with two-stage meta-analysis incorporating individual participant data in line with PRISMA-IPD best practices.12 Increasing guidance to clinician decision-making enhances patient care. The question to answer: is there a difference in outcomes according to patient type based on drug received? Alternatively, are the outcomes similar for all patients regardless of drug choice?"
  ["project_specific_aims"]=>
  string(311) "Aim: To compare the therapy-related AE outcomes of enzalutamide and abiraterone for metastatic castration-resistant prostate cancer through individual participant data (IPD) meta-analysis of clinical trial data.

Hypothesis: Enzalutamide will have lower AE and CVD risk than abiraterone in mCRPC patients."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_study_design_exp"]=>
  string(0) ""
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  }
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  string(0) ""
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  ["project_research_methods"]=>
  string(905) "Eligibility for trials

Study designs: RCTs or single-arm trials.

Participants: included mCRPC patients.

Interventions: enzalutamide or abiraterone in combination with ADT.

Comparators: any comparators or single-arm trials with no comparator.

Outcomes: reported efficacy and safety outcomes. The main outcome measure is time to and frequency of grade 3 or 4 therapy-related adverse events.

Timing and setting: median duration of follow-up more than 12 months; any setting.

Language and year: English language; year since 2011- abiraterone was approved in 2011, enzalutamide in 2012.

Enzalutamide RCTs (NCT02384382, NCT02215096, NCT01664923, NCT01212991, NCT02485691) to be requested from Vivli (Request ID# 8688) and analysis to be conducted under Vivli-YODA agreement at Vivli secure platform. See attachment for description of enzalutamide studies."
  ["project_main_outcome_measure"]=>
  string(316) "1. Primary outcome: time to and frequency of grade 3 or 4 therapy-related adverse events.

2. Secondary outcome: time to composite of four cardiovascular risk and mortality outcomes: acute myocardial infarction events, heart failure events, cardiovascular related deaths, and non-cardiovascular related deaths."
  ["project_main_predictor_indep"]=>
  string(65) "Drug category: abiraterone, enzalutamide, or placebo/no treatment"
  ["project_other_variables_interest"]=>
  string(508) "Composite of four cardiovascular risk and mortality outcomes (dichotomous); acute myocardial infarction events (count), heart failure events (count), cardiovascular related deaths (dichotomous), and non-cardiovascular related deaths (dichotomous);

Age (continuous), race (categorical),  prostate specific antigen (PSA) level (continuous), PSA density (continuous), PSA doubling time (continuous), Gleason category (categorical), previous therapy for PCa (categorical), performance status (categorical)"
  ["project_stat_analysis_plan"]=>
  string(2904) "Eligibility for trials

Study designs: RCTs or single-arm trials. Phase I trials, cross-over trials, cluster RCTs, or quasi-randomized trials will be excluded.

Participants: included mCRPC patients.

Interventions: enzalutamide or abiraterone in combination with ADT.

Comparators: any comparators or single-arm trials with no comparator.

Outcomes: reported efficacy and safety outcomes. The main outcome measure is time to and frequency of grade 3 or 4 therapy-related adverse events.

Timing and setting: median duration of follow-up more than 12 months; any setting.

Language and year: English language; year since 2011- abiraterone was approved in 2011, enzalutamide in 2012.

Ways to handle missing data:

We will contact principle investigators for missing data. And in case where missing data were not because of the reporting of trial results but because of loss-to-follow up or data collection issues, we will use multiple imputation to address missing data in covariates and outcomes.

Ways to handle differences in outcome measures: we specified our primary and secondary outcomes based on a preliminary search and review of eligible trials. We selected outcomes that are consistently reported across trials.

Ways to handle the differences in study designs: we limited eligible trials to randomized controlled trials and single-arm trials with at least 12 months of median follow-up time. As the drug dosage and regimen are established for the drug therapies of interest, we expect little variation in terms of the administration of intervention. Statistically, we will use random effects model to account for heterogeneity in study results derived from different study designs.

We will conduct IPD meta-analysis utilizing a two-stage approach as discussed by Walker et al13 and espoused by the Cochrane Individual Participant Data Meta-analysis Methods Group. 14 Stage one will include a summary of each individual trial. Stage two will involve a meta-regression stratified by study type using mixed effects modeling techniques with structures that account for the relative similarity (i.e., correlation) of observations within the same study by random effects when we generalize effect estimation and inference across studies by fixed effects thus comparing the exposure of interest (the independent variable, abiraterone and enzalutamide). This methodology will also serve to maintain the overall structure of the individual studies, as they will not be treated as an overall aggregate and analyzed as though they were drawn from a single study and ostensibly independent and identically distributed (iid) observations. The dichotomous outcomes will be determined by using an odds ratio (OR) with 95% credible intervals (CI). The time-to-event outcomes will be determined by using a hazard ratio (HR) with 95% CI."
  ["project_timeline"]=>
  string(228) "Anticipated project start date: February 2023

Analysis completion date: January 2024

Manuscript drafted: June 2024

First submission: July 2024

Results reported back to the YODA project: September 2024"
  ["project_dissemination_plan"]=>
  string(187) "Products: A manuscript to be published in major oncology journals (Journal of Clinical Oncology, JAMA, JAMA Oncology, etc).

Audiences: Clinicians, patients, and health researchers."
  ["project_bibliography"]=>
  string(2984) "
1. American Cancer Society. Prostate at a glance. Estimated new cases, 2022. Accessed December 27, 2022. https://cancerstatisticscenter.cancer.org/#!/cancer-site/Prostate

2. Lin E, Garmo H, Van Hemelrijck M, et al. Association of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer With Cardiovascular Disease Risk and Hypertension in Men With Diabetes. JAMA Netw Open. Aug 1 2022;5(8):e2225600. doi:10.1001/jamanetworkopen.2022.25600

3. Gupta D, Lee Chuy K, Yang JC, Bates M, Lombardo M, Steingart RM. Cardiovascular and Metabolic Effects of Androgen-Deprivation Therapy for Prostate Cancer. J Oncol Pract. Oct 2018;14(10):580-587. doi:10.1200/jop.18.00178

4. Keating NL, O’Malley AJ, Freedland SJ, Smith MR. Diabetes and Cardiovascular Disease During Androgen Deprivation Therapy: Observational Study of Veterans With Prostate Cancer. JNCI: Journal of the National Cancer Institute. 2010;102(1):39-46. doi:10.1093/jnci/djp404

5. Iacovelli R, Ciccarese C, Bria E, et al. The Cardiovascular Toxicity of Abiraterone and Enzalutamide in Prostate Cancer. Clin Genitourin Cancer. Jun 2018;16(3):e645-e653. doi:10.1016/j.clgc.2017.12.007

6. Moreira RB, Debiasi M, Francini E, et al. Differential side effects profile in patients with mCRPC treated with abiraterone or enzalutamide: a meta-analysis of randomized controlled trials. Oncotarget. Oct 13 2017;8(48):84572-84578. doi:10.18632/oncotarget.20028

7. Cone EB, Reese S, Marchese M, et al. Cardiovascular toxicities associated with abiraterone compared to enzalutamide-A pharmacovigilance study. EClinicalMedicine. Jun 2021;36:100887. doi:10.1016/j.eclinm.2021.100887

8. Hu J, Aprikian AG, Vanhuyse M, Dragomir A. Comparative Cardiovascular Safety of Novel Hormonal Agents in Metastatic Castration-Resistant Prostate Cancer Using Real-World Data. Clin Genitourin Cancer. Feb 2022;20(1):17-24. doi:10.1016/j.clgc.2021.08.009

9. Scailteux LM, Despas F, Balusson F, et al. Hospitalization for adverse events under abiraterone or enzalutamide exposure in real-world setting: A French population-based study on prostate cancer patients. Br J Clin Pharmacol. Jan 2022;88(1):336-346. doi:10.1111/bcp.14972

10. Lee HY, Chen HL, Teoh JY, et al. Abiraterone and enzalutamide had different adverse effects on the cardiovascular system: a systematic review with pairwise and network meta-analyses. Prostate Cancer Prostatic Dis. Mar 2021;24(1):244-252. doi:10.1038/s41391-020-00275-3

11. Zhu J, Liao R, Su C, et al. Toxicity profile characteristics of novel androgen-deprivation therapy agents in patients with prostate cancer: a meta-analysis. Expert Rev Anticancer Ther. Feb 2018;18(2):193-198. doi:10.1080/14737140.2018.1419871

12. Stewart LA, Clarke M, Rovers M, et al. Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement. Jama. Apr 28 2015;313(16):1657-65. doi:10.1001/jama.2015.3656
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