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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(257) "NCT01715285 - A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)"
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  ["project_title"]=>
  string(148) "DEFINE: Deep Early Prostate-Specific Antigen (PSA) response Failure: Identifying Nonresponders in Early Metastatic Hormone-Sensitive Prostate Cancer"
  ["project_narrative_summary"]=>
  string(719) "Metastatic hormone-sensitive prostate cancer (mHSPC) is an advanced form of prostate cancer that still responds to hormone-lowering treatments. Recent advances combining androgen deprivation therapy with chemotherapy or targeted hormonal agents have improved survival, but up to one-third of patients do not achieve a strong early response. Prostate-specific antigen (PSA) decline at 6 months is a key marker of treatment effectiveness, and patients who do not reach PSA <0.2 ng/mL have poorer outcomes. This study will analyze data from multiple clinical trials and real-world cohorts to better characterize these patients, identify predictive factors of non-response, and improve personalized treatment strategies."
  ["project_learn_source"]=>
  string(5) "other"
  ["project_learn_source_exp"]=>
  string(5) "VIVLI"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Carole"
    ["last_name"]=>
    string(8) "Helissey"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(27) "Hôpital Paris Saint-Joseph"
    ["email"]=>
    string(18) "chelissey@ghpsj.fr"
    ["state_or_province"]=>
    string(5) "Paris"
    ["country"]=>
    string(6) "France"
  }
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      ["p_pers_f_name"]=>
      string(7) "Edouard"
      ["p_pers_l_name"]=>
      string(6) "Auclin"
      ["p_pers_degree"]=>
      string(3) "PhD"
      ["p_pers_pr_affil"]=>
      string(18) "Institut Bergonié"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
  }
  ["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(1487) "Background:

Metastatic hormone-sensitive prostate cancer (mHSPC) outcomes have improved with treatment intensification, yet 30–40% of patients fail to achieve a deep PSA response at 6 months, a key prognostic marker associated with poor survival.



Objective:

To characterize patients with primary resistance to first-line intensified therapy and identify predictive factors of biochemical non-response at 6 months.



Study Design:

Pooled retrospective analysis of prospectively collected data from six phase III trials and one real-world cohort.



Participants:

Approximately 6,500–7,000 patients with mHSPC treated with first-line intensified therapy and available PSA at 6 months.



Primary and Secondary Outcome Measures:

Primary outcome: absence of deep PSA response (PSA ≥0.2 ng/mL at 6 months).

Secondary outcomes: overall survival, radiographic progression-free survival, time to castration resistance, time to next treatment, and characterization of treatment patterns in non-responders.



Statistical Analysis:

Within-study analyses will be performed, followed by random-effects meta-analysis to account for heterogeneity. Survival outcomes will be estimated using Kaplan–Meier methods and compared with log-rank tests. Predictive factors will be assessed using multivariable logistic regression, with adjustment for key clinical and biological variables."
  ["project_brief_bg"]=>
  string(3155) "Metastatic hormone-sensitive prostate cancer (mHSPC) represents a major public health burden, with prostate cancer accounting for approximately 1.5 million new cases and 375,000 deaths annually worldwide. Over the past decade, the treatment landscape has evolved significantly, with the introduction of early treatment intensification strategies combining androgen deprivation therapy (ADT) with docetaxel chemotherapy and/or androgen receptor pathway inhibitors (ARPIs). These approaches have consistently demonstrated improved overall survival across multiple phase III trials and are now considered standard of care.



Despite these advances, a substantial proportion of patients (approximately 30–40%) fail to achieve a deep biochemical response, defined as a prostate-specific antigen (PSA) level <0.2 ng/mL at 6 months. This early PSA response has emerged as one of the most robust prognostic markers in mHSPC, strongly associated with long-term outcomes regardless of treatment modality. Patients who do not achieve this threshold have significantly worse overall survival and earlier disease progression. However, this high-risk population remains poorly characterized, and the biological and clinical determinants of primary resistance to contemporary intensified therapies are not well understood.



Addressing this gap is critical, as current treatment strategies do not adequately account for early treatment failure. Identifying patients at high risk of non-response could enable earlier therapeutic adaptation, including treatment escalation, switching strategies, or enrollment in clinical trials. Furthermore, understanding the heterogeneity within non-responders may help distinguish patients with aggressive disease from those with more indolent trajectories despite suboptimal PSA decline.



This project aims to leverage individual patient-level data from multiple large randomized clinical trials and a real-world cohort to comprehensively characterize patients with biochemical non-response at 6 months. By integrating clinical, biological, and treatment-related variables across diverse populations and therapeutic strategies, this study will identify predictive factors of resistance, evaluate outcomes, and explore treatment patterns in this understudied group.



The expected impact of this work is substantial. It will provide robust, generalizable evidence to refine risk stratification in mHSPC, transform early PSA response into an actionable clinical decision-making tool, and support the development of personalized treatment strategies. Ultimately, this research will contribute to improving outcomes for patients with poor prognosis and inform future clinical trial design targeting early treatment resistance.



References:

Sweeney et al., NEJM 2015 (CHAARTED); Fizazi et al., NEJM 2017 (LATITUDE); Armstrong et al., NEJM 2019 (ARCHES); Chi et al., NEJM 2019 (TITAN); Davis et al., NEJM 2019 (ENZAMET); Fizazi et al., NEJM 2022 (ARASENS); Fizazi et al., Lancet 2022 (PEACE-1); George et al., JCO 2020 (PSA response analysis); IRONMAN Registry."
  ["project_specific_aims"]=>
  string(1335) "This project aims to characterize patients with metastatic hormone-sensitive prostate cancer (mHSPC) who exhibit primary resistance to first-line intensified therapy, defined as failure to achieve a prostate-specific antigen (PSA) level <0.2 ng/mL at 6 months.



The primary objective is to describe the clinical, biological, and tumor characteristics of these non-responders.



Secondary objectives include: (1) comparing baseline characteristics between responders and non-responders; (2) identifying predictive factors of biochemical non-response, including demographic, clinical, tumor, and treatment-related variables; (3) evaluating outcomes associated with non-response, including overall survival, radiographic progression-free survival, time to castration resistance, and time to next treatment; (4) assessing treatment patterns and subsequent management strategies in non-responders; and (5) exploring heterogeneity within non-responders to identify distinct prognostic subgroups.



The main hypotheses are that failure to achieve PSA <0.2 ng/mL at 6 months defines a distinct high-risk population, that baseline characteristics can predict non-response, and that early biochemical non-response is independently associated with worse clinical outcomes across treatment strategies."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(4) {
    [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"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(18) "summary_level_data"
      ["label"]=>
      string(32) "Summary-level data meta-analysis"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(52) "summary_level_data_meta_analysis_from_yoda_and_other"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
    }
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  ["project_research_methods"]=>
  string(1722) "For the YODA studies included in this project, patients will be selected according to the following analysis-specific criteria, applied after access to the trial datasets. Eligible patients must have: (1) histologically confirmed adenocarcinoma of the prostate; (2) metastatic hormone-sensitive prostate cancer (mHSPC) at study entry; (3) received first-line intensified therapy; (4) available PSA measurement at 6 months (±4 weeks) after treatment initiation; and (5) adequate baseline clinical and biological data. Exclusion criteria are: (1) missing PSA data at 6 months; (2) discontinuation before 6 months for reasons other than disease progression (e.g. toxicity, withdrawal, death); (3) castration-resistant prostate cancer at baseline; (4) prior systemic treatment for metastatic disease, except ADT initiated within 3 months before study entry if allowed by the original trial; and (5) patients from control arms will not be included.

Other studies to be used in this project include PEACE-1, LATITUDE, ARCHES, ENZAMET, TITAN, and ARANOTE, obtained through Vivli/data-sharing study sponsor holders. The full project is a multi-study analysis of prospectively collected datasets from six phase III trials and one real-world cohort.

We do not plan to pool external individual participant-level datasets with YODA data on a single platform. Analyses will be conducted separately within each study-specific environment. Only summary-level results (e.g. descriptive statistics and effect estimates) will be exported and combined across studies using meta-analytic approaches. This ensures compliance with platform-specific governance requirements while preserving study-level structure and independence."
  ["project_main_outcome_measure"]=>
  string(1734) "Primary Outcome Measure:

The primary outcome is the absence of deep biochemical response at 6 months, defined as a prostate-specific antigen (PSA) level ≥0.2 ng/mL measured at 6 months (±4 weeks) after treatment initiation. This variable will be analyzed as a binary outcome: responder (PSA <0.2 ng/mL) versus non-responder (PSA ≥0.2 ng/mL).



Secondary Outcome Measures:

Secondary outcomes include:

Overall survival (OS): time from treatment initiation to death from any cause.

Radiographic progression-free survival (rPFS): time from treatment initiation to radiographic progression or death.

Time to castration resistance: time from treatment initiation to development of castration-resistant prostate cancer according to PCWG3 criteria.

Time to next treatment: time from treatment initiation to initiation of second-line systemic therapy.

PSA kinetics during the first 6 months: including PSA nadir, time to PSA nadir, PSA velocity, and PSA doubling time.

Rate of non-response at 6 months in predefined subgroups (e.g., triplet therapy).

Clinical and biological characteristics associated with non-response.

Treatment patterns in non-responders, including continuation versus switch and type of subsequent therapy.

All time-to-event outcomes will be analyzed using standard survival methods and censored at last follow-up.



Changes to Outcome Measures:

No major changes to the primary or secondary outcome measures are anticipated. Any minor adaptations required due to differences in variable definitions across studies will be harmonized using standardized definitions to ensure comparability across datasets."
  ["project_main_predictor_indep"]=>
  string(1504) "The main predictor (independent variable) in this study is the early biochemical response to first-line intensified therapy, defined by prostate-specific antigen (PSA) level at 6 months after treatment initiation (±4 weeks).

This variable will be categorized as a binary variable:

Responder: PSA <0.2 ng/mL

Non-responder: PSA ≥0.2 ng/mL



This definition is based on established evidence demonstrating that a PSA threshold of 0.2 ng/mL at 6 months is a robust prognostic marker across multiple studies and treatment strategies in metastatic hormone-sensitive prostate cancer.

The primary analysis will assess the association between PSA response status and clinical outcomes, including overall survival, radiographic progression-free survival, time to castration resistance, and time to next treatment.

In addition, PSA response status will also be used as the dependent variable in predictive modeling analyses aimed at identifying baseline factors associated with non-response. In this context, baseline demographic (e.g., age), clinical (e.g., performance status), tumor-related (e.g., disease volume, Gleason score), biological (e.g., baseline PSA, hemoglobin, LDH), and treatment-related variables (e.g., type of intensified therapy) will be evaluated as independent predictors of biochemical non-response.

All variables will be harmonized across studies using standardized definitions to ensure consistency and comparability of analyses."
  ["project_other_variables_interest"]=>
  string(1732) "In addition to the main predictor, several variables will be included to characterize the study population and for multivariable adjustment.



Demographic variables:

Age (continuous and categorized), geographic region, and ethnicity (as available in each dataset).



Clinical variables:

Performance status (ECOG, categorized as 0, 1, ≥2), body mass index (continuous), and comorbidity indicators (as available).



Tumor characteristics:

Disease volume according to CHAARTED criteria (high vs low volume), presence of visceral metastases (yes/no), Gleason score (≤7 vs ≥8), number and sites of metastases, and disease presentation (synchronous vs metachronous).



Biological parameters at baseline:

PSA level (continuous and categorized), testosterone level, hemoglobin, lactate dehydrogenase (LDH), alkaline phosphatase, and albumin (continuous, with clinically relevant categorizations where appropriate).

Treatment-related variables:

Type of first-line intensified therapy (ADT + ARPI, ADT + docetaxel, or triplet therapy), type of ARPI, and use of docetaxel (yes/no).



PSA kinetics:

PSA nadir, time to nadir, PSA velocity, and PSA doubling time during the first 6 months.



Post–6-month management variables:

Treatment continuation versus change, type of second-line therapy, and time to treatment modification.



All variables will be harmonized across studies using standardized definitions. Continuous variables may be analyzed as continuous or categorized based on clinically relevant thresholds. Missing data will be handled using multiple imputation when appropriate."
  ["project_stat_analysis_plan"]=>
  string(895) "All analyses will be conducted according to a pre-specified statistical plan. Given the inclusion of multiple clinical trials and one real-world cohort, analyses will preserve the structure and independence of each study.



Descriptive Analysis:

Baseline characteristics will be summarized within each study and overall. Continuous variables will be described using mean and standard deviation or median and interquartile range, depending on distribution. Categorical variables will be summarized as frequencies and percentages.



Bivariate Analysis:

Comparisons between responders (PSA 20%) may be excluded or analyzed in sensitivity analyses.



Software and Statistical Significance:

All analyses will be performed using validated statistical software (e.g., R or SAS). All tests will be two-sided, with a significance level of 0.05."
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(1) "r"
      ["label"]=>
      string(1) "R"
    }
  }
  ["project_timeline"]=>
  string(971) "Project start date: Within 1 month following data access approval and Data Use Agreement (DUA) execution.



Data preparation and harmonization: Months 1–3, including data familiarization, variable mapping, and definition harmonization across studies.



Primary and secondary analyses: Months 4–8, including descriptive, comparative, survival, and multivariable analyses conducted within each study.



Meta-analysis and sensitivity analyses: Months 7–9, including aggregation of study-specific estimates and subgroup analyses.



Manuscript drafting: Months 9–10.



Manuscript submission: Month 11 to a peer-reviewed oncology journal.



Reporting of results to the YODA Project: Within 12 months of data access, in accordance with Data Use Agreement requirements.



If needed, an extension may be requested to complete additional analyses or revisions following peer review."
  ["project_dissemination_plan"]=>
  string(1069) "The primary output of this project will be a peer-reviewed scientific manuscript reporting the characterization, outcomes, and predictive factors of early biochemical non-response in metastatic hormone-sensitive prostate cancer.



We plan to submit the main manuscript to high-impact journals in oncology and urology, such as Journal of Clinical Oncology, European Urology, or The Lancet Oncology. Additional secondary analyses (e.g., subgroup analyses or predictive modeling results) may lead to further publications.



Results will also be presented at major international conferences, including ASCO, ESMO, and EAU, to ensure rapid dissemination to the oncology community.



The target audience includes medical oncologists, urologists, clinical researchers, and other healthcare professionals involved in prostate cancer management.



Where appropriate, findings may also be shared with broader audiences through institutional communication channels to support knowledge translation and improve clinical practice."
  ["project_bibliography"]=>
  string(12101) "


Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373:737–746.


Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017;377:352–360.


Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: Enzalutamide plus androgen deprivation therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2019;381:121–131.


Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med.2019;381:13–24.


Davis ID, Martin AJ, Stockler MR, et al. Enzalutamide with standard first-line therapy in metastatic prostate cancer (ENZAMET). N Engl J Med. 2019;381:121–131.


Fizazi K, Shore N, Tammela TL, et al. Darolutamide in metastatic, hormone-sensitive prostate cancer (ARASENS). N Engl J Med. 2022;386:1132–1142.


Fizazi K, Maldonado X, Foulon S, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in metastatic castration-sensitive prostate cancer (PEACE-1). Lancet. 2022;399:1695–1707.


George DJ, Sartor O, Miller K, et al. Treatment effect of early PSA decline in metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2020;38:2968–2976.


Gillessen S, Attard G, Beer TM, et al. Management of patients with advanced prostate cancer: report of the Advanced Prostate Cancer Consensus Conference (APCCC). Ann Oncol. 2020;31:1119–1134.


IRONMAN Study Group. International registry for men with advanced prostate cancer (IRONMAN): real-world outcomes and PSA response analyses. Eur Urol. [in press ].


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    string(19) "2026-03-10 19:58:49"
    ["modified"]=>
    string(19) "2026-03-10 19:58:49"
    ["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_review_link"]=>
  bool(false)
  ["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"
}