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      string(210) "NCT02489318 - A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)"
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      string(170) "NCT01946204 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer"
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  ["project_title"]=>
  string(118) "Impact of skin adverse events on survival outcomes in metastatic CSPC and non-metastatic CRPC treated with apalutamide"
  ["project_narrative_summary"]=>
  string(828) "Apalutamide combined with androgen deprivation therapy (ADT) has become a standard treatment option in metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer, based on the results of the phase 3 TITAN and SPARTAN trials. skin AE is one of the most characteristic and frequent adverse events of apalutamide and often leads to dose interruption, dose reduction, or treatment discontinuation. However, it remains unclear whether treatment-related skin rash is simply a tolerability issue or whether it is also associated with survival outcomes. This post hoc analysis aims to use individual participant-level data from the TITAN and SAPRTAN trials to evaluate the relationships between apalutamide-related skin AE, survival outcomes, treatment duration, and relative dose intensity."
  ["project_learn_source"]=>
  string(6) "pubmed"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Yohei "
    ["last_name"]=>
    string(6) "Sekino"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(20) "Hiroshima University"
    ["email"]=>
    string(26) "swimming@hiroshima-u.ac.jp"
    ["state_or_province"]=>
    string(9) "Hiroshima"
    ["country"]=>
    string(5) "Japan"
  }
  ["project_key_personnel"]=>
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    [0]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(7) "Kazuma "
      ["p_pers_l_name"]=>
      string(8) "Yukihiro"
      ["p_pers_degree"]=>
      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(20) "Hiroshima University"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
    [1]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(5) "Ayako"
      ["p_pers_l_name"]=>
      string(8) "Takamori"
      ["p_pers_degree"]=>
      string(27) "PhD (Medical Biostatistics)"
      ["p_pers_pr_affil"]=>
      string(20) "Hiroshima University"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(2) "no"
    }
  }
  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(2) "no"
    ["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(1738) "Background

Apalutamide plus ADT significantly improves overall survival (OS) and radiographic progression-free survival (rPFS) in patients with mCSPC and nmCRPC. skin AE is a well-recognized adverse event of apalutamide. however, the clinical implications of this toxicity for long-term survival outcomes remain unclear. 





Objective

To investigate the association between treatment-related skin AE and survival outcomes in patients with mCSPC and nmCRPC treated with apalutamide plus ADT in the TITAN and SPARTAN trial, and to assess whether skin AE can serve as an early on-treatment marker of therapeutic benefit.



Study design

Post-hoc analysis of individual participant-level data.



Participants

Patients with mCSPC and nmCRPC in the TITAN and SPARTAN trials.



Primary and secondary measures

Primary: OS

Secondary endpoints: rPFS, treatment duration and time to discontinuation (including AE-related discontinuation), relative dose intensity (RDI) of apalutamide, and landmark OS at 6 months after treatment initiation



Statistical analysis:

•  Survival Analysis:

•	Kaplan–Meier method for OS and PFS.

•	Log‐rank test to compare survival curves according to apalutamide-related skin AE (yes vs no) and other subgroups.

•	Cox proportional hazards regression to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), with skin rash modeled as a time-dependent and landmark (6-month) covariate, adjusting for key baseline covariates (age, ECOG PS, Gleason score, PSA, body weight, visceral and lymph-node metastases, number of bone metastases, HGB, ALP, LDH).

"
  ["project_brief_bg"]=>
  string(2218) "Apalutamide in combination with androgen deprivation therapy (ADT) is a well-established standard of care for patients with metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC), based on the phase 3 TITAN and SPARTAN trials. While apalutamide provides substantial survival benefits, treatment-related skin adverse events (AEs), including rash and pruritus, represent one of its most frequent and characteristic toxicities. These skin AEs often lead to dose interruption, dose reduction, or treatment discontinuation, particularly in Asian patients, raising important concerns regarding treatment tolerability and long-term adherence.



Despite the clinical relevance of skin AEs, their implications beyond tolerability remain poorly understood. Specifically, it is unclear whether the occurrence of apalutamide-related skin AEs merely reflects an adverse drug reaction requiring management, or whether it may serve as an on-treatment biomarker associated with treatment exposure, dose intensity, and ultimately survival outcomes. In other targeted and immunotherapeutic agents, certain treatment-emergent toxicities have been associated with improved clinical outcomes, suggesting a potential link between drug exposure, biological activity, and efficacy. However, this relationship has not been systematically evaluated for apalutamide-related skin AEs using individual participant-level data.



The proposed post-hoc analysis leveraging high-quality individual participant-level data from the TITAN and SPARTAN trials provides a unique opportunity to address this clinically important knowledge gap. By evaluating the association between skin AEs, treatment exposure, relative dose intensity, and survival outcomes using robust time-dependent and landmark analyses, this study aims to clarify the prognostic and predictive relevance of apalutamide-related skin AEs. The findings have the potential to inform risk stratification, optimize toxicity management strategies, and improve clinical decision-making for patients receiving apalutamide, particularly in populations at higher risk for treatment-related skin toxicity."
  ["project_specific_aims"]=>
  string(204) "The aim of this project is to investigate the prognostic and predictive impact of apalutamide-related skin AE on clinical outcomes in patients with mCSPC and nmCRPC enrolled in the TITAN and SPARTAN trial"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
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    ["label"]=>
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  }
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["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"
    }
  }
  ["project_research_methods"]=>
  string(2142) "Data Source



This study will utilize individual participant-level data obtained through The YODA Project from two phase 3, randomized, double-blind, placebo-controlled clinical trials of apalutamide:



TITAN trial (NCT02489318), which evaluated apalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with metastatic castration-sensitive prostate cancer (mCSPC).



SPARTAN trial (NCT01946204), which evaluated apalutamide versus placebo in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).



Available data will include baseline demographic and clinical characteristics, treatment exposure and dosing information, adverse event data (including detailed skin adverse events), and efficacy outcomes such as overall survival (OS) and radiographic progression-free survival (rPFS), as provided in the clinical study reports and supporting datasets.



Inclusion Criteria



Patients will be included in the analysis if they meet all of the following criteria:



Enrolled in the TITAN or SPARTAN trial



Randomized to receive either apalutamide or placebo in combination with protocol-specified background therapy (ADT as applicable)



Received at least one dose of study treatment



Had available adverse event data enabling assessment of treatment-emergent skin adverse events



Had available follow-up data for survival outcomes (OS and/or rPFS)



Exclusion Criteria



Patients will be excluded from the analysis if they meet any of the following criteria:



Did not receive any dose of the assigned study treatment



Had missing or incomplete adverse event data that preclude evaluation of treatment-emergent skin adverse events



Had missing key baseline covariates required for multivariable survival analyses (e.g., age, ECOG performance status)



Were lost to follow-up immediately after randomization, precluding assessment of clinical outcomes



"
  ["project_main_outcome_measure"]=>
  string(476) "Primary Outcome: OS: Time from randomization to death from any cause. 

rPFS: Time from randomization to documented disease progression or death from any cause, whichever occurs first. 

Secondary Outcome: Treatment exposure: treatment duration and time to treatment discontinuation, including discontinuation due to adverse events. RDI of apalutamide. Landmark OS at 6 months after treatment initiation, including only patients who are alive at 6 months. 

"
  ["project_main_predictor_indep"]=>
  string(436) "The main independent variable will be treatment-emergent skin AE during apalutamide therapy.



Categorization/Definition:



Skin AE will be defined based on investigator‐reported adverse event terms related to rash or pruritus and graded according to CTCAE in the TITAN and SPARTAN dataset. In the primary analyses, Skin AE will be coded as a binary variable (any-grade skin rash: yes vs no).



"
  ["project_other_variables_interest"]=>
  string(486) "•  Age: 7

•  Body weight: <70 kg vs. ≥70 kg

•  Baseline hemoglobin (HGB), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH): each dichotomized at the cohort median (low vs. high)

•  Relative dose intensity (RDI) of apalutamide was calculated as the ratio of the actual cumulative dose received to the planned cumulative dose over the treatment period, taking into account dose reductions and temporary treatment interruptions.



"
  ["project_stat_analysis_plan"]=>
  string(927) "The following statistical analysis will be implemented using R and JMP software.



Descriptive statistics will summarize baseline characteristics by skin-rash status using medians (interquartile range) for continuous variables and frequencies (%) for categorical variables. 

OS and rPFS will be estimated using the Kaplan–Meier method and compared between groups using the log-rank test. 

Cox proportional hazards models will be used to estimate hazard ratios and 95% confidence intervals for the association between skin rash and outcomes, adjusting for key covariates listed above. 

Skin rash will be evaluated both as a time-dependent covariate and in landmark Cox models at 6 months after treatment initiation among patients alive at each landmark. 

Treatment duration and RDI will be compared between groups using Wilcoxon rank-sum tests or appropriate regression models.

"
  ["project_software_used"]=>
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    [0]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(803) "The project will span approximately 12 months.

During months 1–2, we will finalize the analysis plan, derive key variables (e.g., skin AE timing and grade, dose intensity), and complete data cleaning and quality checks.

During months 3–6, we will conduct descriptive analyses, survival analyses (OS, rPFS), landmark analyses at 3 and 6 months, and multivariable Cox modeling to evaluate the prognostic and predictive impact of apalutamide-related skin rash.

During months 7–9, we will draft the manuscript, create tables and figures, and refine the analyses based on internal co-author feedback.

The final 3 months (months 10–12) will be devoted to manuscript revision, journal submission, and preparation of abstracts for major oncology and urology meetings.

"
  ["project_dissemination_plan"]=>
  string(622) "We plan to disseminate the findings of this project through multiple channels.

Our primary output will be a manuscript submitted to a peer-reviewed oncology or urology journal focusing on treatment-related toxicity and outcomes in mCSPC and nmCRPC. In addition to journal publication, we will present our results at major international and regional meetings, such as the ASCO Annual Meeting and the European Association of Urology (EAU) and Japanese Urological Association (JUA) congresses. We will also share a summary of key results with the YODA Project to inform future data-sharing initiatives.



"
  ["project_bibliography"]=>
  string(1344) "
Chi, K. N., Agarwal, N., Bjartell, A., Chung, B. H., Pereira de Santana Gomes, A. J., Given, R., Juárez Soto, Á., Merseburger, A. S., Özgüroğlu, M., Uemura, H., Ye, D., Deprince, K., Naini, V., Li, J., Cheng, S., Yu, M. K., Zhang, K., Larsen, J. S., McCarthy, S., … TITAN Investigators. (2019). Apalutamide for metastatic, castration-sensitive prostate cancer. The New England Journal of Medicine, 381(1),
13–24.
Smith, M. R., Saad, F., Chowdhury, S., Oudard, S., Hadaschik, B. A., Graff, J. N., Olmos, D., Mainwaring, P. N., Lee, J. Y., Uemura, H., Lopez-Gitlitz, A., Trudel, G. C., Espina, B. M., Shu, Y., Park, Y. C., Small, E. J., & SPARTAN Investigators. (2018). Apalutamide treatment and metastasis-free survival in prostate cancer. The New England Journal of Medicine, 378(15), 1408–1418. https://doi.org/10.1056/NEJMoa1715546
"
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    string(87) "https://yoda.yale.edu/wp-content/uploads/2025/12/YODA-Project-Review-2025-0920_site.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2025-0920/yoda-project-review-2025-0920_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2025-0920_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(18480)
    ["date"]=>
    string(19) "2026-02-13 14:58:06"
    ["modified"]=>
    string(19) "2026-02-13 14:58:06"
    ["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(0) ""
}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


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


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