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  ["project_title"]=>
  string(130) "ANDRO-HEME (Androgen Deprivation and Hematologic Effects in Men): An Individual Participant-Level Meta-Analysis of Clinical Trials"
  ["project_narrative_summary"]=>
  string(533) "Anti-androgen therapies are known to lower hemoglobin, but the magnitude, variability, and clinical relevance of this effect remain unclear. This study will leverage participant-level data from 23 clinical trials to quantify hemoglobin changes across anti-androgen regimens. We will examine baseline blood profiles, track dose-related declines in hemoglobin, and adjust for confounding factors such as chemotherapy and bleeding. Findings will clarify the hematologic impact of androgen suppression and help guide clinical management."
  ["project_learn_source"]=>
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  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(8) "Benjamin"
    ["last_name"]=>
    string(8) "Chin-Yee"
    ["degree"]=>
    string(9) "MD, FRCPC"
    ["primary_affiliation"]=>
    string(49) "Western University, London Health Sciences Centre"
    ["email"]=>
    string(28) "benjamin.chin-yee@lhsc.on.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
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      ["p_pers_f_name"]=>
      string(5) "Cyrus"
      ["p_pers_l_name"]=>
      string(4) "Hsia"
      ["p_pers_degree"]=>
      string(9) "MD, FRCPC"
      ["p_pers_pr_affil"]=>
      string(49) "Western University, London Health Sciences Centre"
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      string(9) "Jenyvette"
      ["p_pers_l_name"]=>
      string(4) "Hsia"
      ["p_pers_degree"]=>
      string(2) "NA"
      ["p_pers_pr_affil"]=>
      string(49) "Western University, London Health Sciences Centre"
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      ["p_pers_l_name"]=>
      string(7) "Derkzen"
      ["p_pers_degree"]=>
      string(2) "NA"
      ["p_pers_pr_affil"]=>
      string(49) "Western University, London Health Sciences Centre"
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      ["requires_data_access"]=>
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  ["project_ext_grants"]=>
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    ["value"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1505) "Background: Anti-androgen therapies such as abiraterone and apalutamide are standard treatments for prostate cancer and are known to suppress hemoglobin production. However, the magnitude of hemoglobin decline, variability across agents and regimens, and the clinical predictors of treatment-related anemia remain poorly defined.



Objective: The primary objective is to quantify the effect of anti-androgen therapies on hemoglobin levels. Secondary objectives include evaluating dose–response relationships and identifying predictors of treatment-related anemia.



Study Design: Individual participant-level data meta-analysis of 23 clinical trials involving abiraterone acetate and/or apalutamide in prostate cancer.



Participants: Adults enrolled in anti-androgen therapy trials with available hemoglobin measurements and relevant clinical covariates, including age, sex, BMI, comorbidities, and concomitant medications.



Primary and Secondary Outcome Measures: The primary outcome is change in hemoglobin from baseline following initiation of anti-androgen therapy. Secondary outcomes include incidence of anemia, defined by WHO criteria (WHO 2024), assessment of dose–response relationships, associations between clinical variables and anemia development, and adverse cardiovascular outcomes.



Statistical Analysis: Descriptive statistics will summarize baseline hematologic values. 

(Please see Supplementary Materials.)"
  ["project_brief_bg"]=>
  string(2702) "Androgens play a central role in stimulating erythropoiesis, acting directly on erythroid progenitors via androgen receptor activation and indirectly by enhancing erythropoietin production. Consequently, suppression of androgen signaling, such as through anti-androgen therapy, is associated with reduced hemoglobin levels and can lead to anemia. In prostate cancer, androgen deprivation therapy (ADT) induces a significant decline in hemoglobin and hematocrit, with a substantial proportion of men developing new-onset anemia (Gagliano-Jucá et al. 2018). Both prospective and retrospective studies have quantified this effect: one cohort study found an average hemoglobin drop of approximately 1–2 g/dL within the first few months of therapy (Curtis et al. 2008), and epidemiologic data from over 10,000 patients showed a nearly threefold increased hazard of anemia with ADT (Hicks et al. 2017). Notably, hemoglobin levels often return to baseline within two years of discontinuing ADT, suggesting reversibility. Anemia related to ADT may contribute to fatigue, impaired quality of life, and adverse clinical outcomes (Alibhai et al. 2009; Gagliano-Jucá et al. 2018).



While anti-androgen–associated hemoglobin suppression is recognized, its magnitude across agents, regimens, and patient populations remains uncertain. Some individuals experience only modest declines, while others develop clinically significant anemia that may warrant further evaluation or intervention (Gagliano-Jucá et al. 2018). Data comparing the hematologic effects of different anti-androgen therapies remain limited. Differences in dosing, use of monotherapy versus combination therapy, and treatment duration may all influence hematologic responses.



This project aims to quantify hemoglobin changes during anti-androgen therapy by conducting a pooled individual participant-level analysis across multiple clinical trials. By examining data from diverse treatment settings and regimens, we will characterize patterns of hemoglobin suppression, identify dose–response relationships, evaluate clinical predictors of anemia, and examine potential association between anemia and adverse cardiovascular outcomes. The significance of this study lies in its ability to inform expectations regarding hematologic changes associated with ADT. These findings will enhance clinicians' ability to monitor hemoglobin trends, distinguish expected treatment-related effects from other causes of anemia, and guide referrals for hematologic evaluation when appropriate. Ultimately, this work will help improve the assessment and management of anemia in patients receiving anti-androgen therapies.

"
  ["project_specific_aims"]=>
  string(1019) "Study Objectives:

To quantify changes in hemoglobin among patients treated with anti-androgen therapies, assess the dose–response relationship, and identify predictors of treatment-related anemia.



Specific Hypotheses:

1.	Anti-androgen therapies are associated with a reduction in hemoglobin levels.

2.	Hemoglobin suppression is dose-dependent across different anti-androgen regimens.

3.	Clinical and demographic factors (e.g., age, BMI, baseline hemoglobin, prior chemotherapy) are associated with risk of anemia.

4.	The magnitude of hemoglobin decline varies by anti-androgen agent and treatment duration.

5.	Most hemoglobin reductions represent expected treatment effects; unexplained declines may indicate other causes requiring clinical investigation.

6.	More severe hemoglobin suppression during anti-androgen therapy is associated with increased risk of adverse cardiovascular events (e.g., myocardial infarction, stroke, thromboembolism).

"
  ["project_study_design"]=>
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    ["label"]=>
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      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
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      ["label"]=>
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    }
    [2]=>
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      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(37) "participant_level_data_only_from_yoda"
      ["label"]=>
      string(51) "Meta-analysis using only data from the YODA Project"
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  ["project_research_methods"]=>
  string(529) "We will conduct a pooled analysis using individual participant-level data from 23 randomized and non-randomized trials of abiraterone acetate and/or apalutamide.



Inclusion criteria: Trials that enrolled prostate cancer patients and collected baseline and follow-up hemoglobin data. Other variables of interest include age, BMI, smoking status, comorbidities, chemotherapy exposure, and medication history.



Exclusion criteria: Trials lacking hemoglobin measurements or relevant clinical data.

"
  ["project_main_outcome_measure"]=>
  string(581) "Primary Outcome:

Change in hemoglobin from baseline following anti-androgen therapy.



Secondary Outcomes:

•	Incidence of anemia, defined by WHO criteria (WHO 2024).

•	Dose–response relationship between anti-androgen exposure and hemoglobin change.

•	Associations between clinical variables (e.g., age, BMI, comorbidities) and risk of anemia.

•	Identification of patients with unexplained or severe anemia.

•	Incidence of adverse cardiovascular events (e.g., myocardial infarction, stroke, thromboembolism)

"
  ["project_main_predictor_indep"]=>
  string(482) "Primary predictors: ADT type and dose (abiraterone, apalutamide)



Other independent variables: patient characteristics (age, sex, BMI, smoking, prior chemotherapy), concomitant medications (e.g., corticosteroids), renal function, and bleeding risk factors



Dependent variables: Hemoglobin levels (continuous), anemia (categorical, defined by WHO sex-specific criteria), change in hemoglobin from baseline, presence of unexplained or severe anemia

"
  ["project_other_variables_interest"]=>
  string(4) "None"
  ["project_stat_analysis_plan"]=>
  string(418) "Descriptive statistics will summarize baseline characteristics and hemoglobin levels. Paired t-tests or Wilcoxon signed-rank tests will assess within-patient changes. Mixed-effects models will evaluate treatment effects over time. Multivariable logistic and linear regression will identify predictors of hemoglobin decline and anemia. Sensitivity analyses will adjust for bleeding, chemotherapy, and other confounders."
  ["project_software_used"]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(271) "The proposed research will begin once approved. Data analyses will be completed within 3 months. Manuscript drafting will take a further 3 months and we will prepare for manuscript submission.  Once manuscript submitted, results will be reported back to the YODA Project."
  ["project_dissemination_plan"]=>
  string(301) "Findings will improve understanding of hematologic effects of anti-androgen therapy and inform clinical management. Results will be submitted to journals such as Blood, JCO, Lancet Oncology, or Prostate Cancer and Prostatic Diseases, and presented at major meetings including ASCO, ASH, EHA, and ESMO."
  ["project_bibliography"]=>
  string(1915) "
Alibhai, Shabbir M.H., Minh Duong-Hua, Rinku Sutradhar, Neil E. Fleshner, Padraig Warde, Angela M. Cheung, and Lawrence F. Paszat. “Impact of Androgen Deprivation Therapy on Cardiovascular Disease and Diabetes.” Journal of Clinical Oncology 27, no. 21 (2009): 3452–3458. https://doi.org/10.1200/JCO.2008.20.0923.
 
Curtis, Kelly K., Terrence J. Adam, Shu-Chuan Chen, Rajiv K. Pruthi, and Michael K. Gornet. “Anaemia Following Initiation of Androgen Deprivation Therapy for Metastatic Prostate Cancer: A Retrospective Chart Review.” Aging Male 11, no. 4 (2008): 157–161. https://doi.org/10.1080/13685530802172438.
 
Gagliano-Jucá, Thiago, Karol M. Pencina, Tomas Ganz, Thomas G. Travison, Philip W. Kantoff, Paul L. Nguyen, Mary-Ellen Taplin, et al. “Mechanisms Responsible for Reduced Erythropoiesis During Androgen Deprivation Therapy in Men with Prostate Cancer.” American Journal of Physiology-Endocrinology and Metabolism 315, no. 6 (2018): E1185–E1193. https://doi.org/10.1152/ajpendo.00272.2018.
 
Hicks, Blánaid M., Adi J. Klil-Drori, Hui Yin, Lysanne Campeau, and Laurent Azoulay. “Androgen Deprivation Therapy and the Risk of Anemia in Men with Prostate Cancer.” Epidemiology 28, no. 5 (2017): 712–718. https://doi.org/10.1097/EDE.0000000000000678.
 
World Health Organization. Guideline on Haemoglobin Cutoffs to Define Anaemia in Individuals and Populations. Geneva: World Health Organization, 2024. https://www.who.int/publications/i/item/9789240088542.
"
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    string(19) "2025-09-03 14:28:14"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
  string(15) "johnson-johnson"
  ["request_overridden_res"]=>
  string(1) "3"
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(2) {
  [0]=>
  string(6) "zytiga"
  [1]=>
  string(7) "erleada"
}


num of trials
array(1) {
  [0]=>
  string(2) "23"
}


res
array(1) {
  [0]=>
  string(1) "3"
}