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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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  ["project_title"]=>
  string(144) "Patterns of metastasis appearance and prognostic differences based on the type of metastasis in metastatic, castration-sensitive prostate cancer"
  ["project_narrative_summary"]=>
  string(608) "In recent years, upfront intensive therapy has become more common for metastatic, castration-sensitive prostate cancer (mCSPC). Previous studies have shown that androgen receptor signaling inhibitors (ARSI) can lead to the development of visceral metastasis in castration-resistant prostate cancer. However, it is still unclear whether the use of ARSI in mCSPC increases or accelerates the appearance of visceral metastasis. In this study, we use data from the TITAN trial to investigate the patterns of metastasis appearance and prognostic differences based on the type of metastasis in patients with mCSPC."
  ["project_learn_source"]=>
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    ["first_name"]=>
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    ["last_name"]=>
    string(4) "Hori"
    ["degree"]=>
    string(4) "M.D."
    ["primary_affiliation"]=>
    string(108) "Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science"
    ["email"]=>
    string(24) "costanzo.rowan@gmail.com"
    ["state_or_province"]=>
    string(8) "Ishikawa"
    ["country"]=>
    string(5) "Japan"
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      string(108) "Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science"
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      string(6) "Makino"
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      string(7) "MD, PhD"
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      string(108) "Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science"
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      ["p_pers_degree"]=>
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      ["p_pers_pr_affil"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1638) "Background

In recent years, upfront intensive therapy has become more common for metastatic, castration-sensitive prostate cancer (mCSPC). Previous studies have shown that androgen receptor signaling inhibitors (ARSI) can lead to the development of visceral metastasis in castration-resistant prostate cancer. However, it is still unclear whether the use of ARSI in mCSPC increases or accelerates the appearance of visceral metastasis. Additionally, it's not clear whether upfront treatment leads to prognostic differences based on the pattern of metastasis compared to conventional androgen deprivation treatment (ADT) alone. 



Objective

To investigate the patterns of metastasis appearance and prognostic differences based on the type of metastasis in patients with mCSPC who were treated with ADT and apalutamide, as compared to those who were treated with ADT plus placebo.



Study Design

A post-hoc analysis, using data on the TITAN trial.



Participants

Patients with mCSPC, treated with ADT in combination with apalutamide or placebo, who showed progression based on radiographic examinations.



Primary and Secondary Outcome Measures

OS, metastasis-free survival (MFS), and time from metastasis to death, categorized by site of metastasis as per the trial protocol.



Statistical Analysis

Descriptive statistics are used to summarize disease progression types and patterns. OS, MFS, and time from metastasis to death based on metastasis site are calculated using Kaplan-Meier analyses and compared using the log-rank test."
  ["project_brief_bg"]=>
  string(1236) "In metastatic, castration-sensitive prostate cancer (mCSPC), the combination treatment of androgen deprivation therapy (ADT) with androgen receptor signaling inhibitors (ARSI) and/or chemotherapy has become increasingly common in recent years.[1] Compared to patients treated with ADT alone, combination therapy has been shown to increase radiographic progression without PSA progression. [2] We presume that patients treated with upfront treatment may exhibit a different pattern of metastasis compared to those receiving ADT alone treatment. 



Previous studies have indicated that ARSI can lead to the development of visceral metastasis in castration-resistant prostate cancer.[3] However, it remains unclear whether the use of ARSI in mCSPC leads to an increase or acceleration in the appearance of visceral metastasis.



In this study, we analyze data from the TITAN trial to investigate the patterns of metastasis appearance and prognostic differences based on the type of metastasis in patients with mCSPC who were treated with ADT and apalutamide, as compared to those who were treated with ADT plus placebo. Addressing these issues might pave the way for novel treatment strategies for mCSPC patients."
  ["project_specific_aims"]=>
  string(859) "The primary objective of this study is to evaluate the patterns of metastasis appearance and prognosis differences based on the type of metastasis in patients with metastatic, castration-sensitive prostate cancer who were undergoing treatment with androgen deprivation therapy (ADT) and apalutamide compared to those receiving ADT plus placebo. The following hypotheses are proposed for this study:



1.	The proportion of visceral metastases will increase in patients treated with the combination of ADT and apalutamide.

2.	The appearance of visceral metastases will occur earlier in patients treated with the combination of ADT and apalutamide.

3.	Patients treated with the combination of ADT and apalutamide will have a different prognosis than patients treated with ADT and placebo, even if they have the same metastatic pattern."
  ["project_study_design"]=>
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    ["label"]=>
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  ["project_purposes"]=>
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      ["value"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(118) "Inclusion criteria: All patients involved in this trial 

Exclusion criteria: Patients with missing outcome data"
  ["project_main_outcome_measure"]=>
  string(130) "OS, metastasis-free survival (MFS), and time from metastasis to death categorized by site of metastasis as per the trial protocol."
  ["project_main_predictor_indep"]=>
  string(67) "The primary variable is the use of apalutamide after randomization."
  ["project_other_variables_interest"]=>
  string(905) "The following variables will be used as covariates in the analysis: 

- Age (categorical)

- Race (categorical)

- Eastern Cooperative Oncology Group performance status (categorical)

- Baseline prostate-specific antigen (continuous)

- Gleason score at diagnosis (categorical)

- Prior local therapy (categorical)

- Presence of visceral metastasis (categorical)

- Presence of lymph node metastasis (categorical)

- Presence of liver metastasis (categorical)

- Presence of lung metastasis (categorical)

- Metastasis stage at initial diagnosis (categorical)

- Baseline hemoglobin (continuous)

- Baseline albumin (continuous)

- Baseline alkaline phosphatase (continuous)

- Baseline lactate dehydrogenase (continuous)

- Previous docetaxel use (categorical)

- Baseline disease volume (categorical)"
  ["project_stat_analysis_plan"]=>
  string(217) "We will use descriptive statistics to outline the baseline characteristics and disease progression patterns. Time-to-event outcomes will be illustrated using Kaplan-Meier analyses and compared using the log-rank test."
  ["project_software_used"]=>
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    ["label"]=>
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  ["project_timeline"]=>
  string(195) "Day 0: Approval of the project 

Day 60: Data transfer

Day 90: Data processing 

Day 120: Data analysis

Day 240: Manuscript writing

Day 360: Manuscript submission"
  ["project_dissemination_plan"]=>
  string(159) "The project is expected to produce a manuscript suitable for publication in a urology journal, with results to be presented at appropriate urology conferences."
  ["project_bibliography"]=>
  string(1073) "
[1] Posdzich P, Darr C, Hilser T, Wahl M, Herrmann K, Hadaschik B, Grünwald V. Metastatic Prostate Cancer-A Review of Current Treatment Options and Promising New Approaches. Cancers (Basel). 2023 Jan 11;15(2):461. doi: 10.3390/cancers15020461. PMID: 36672410; PMCID: PMC9856730.
[2] Fukuokaya W, Yanagisawa T, Mori K, Urabe F, Rajwa P, Briganti A, Shariat SF, Kimura T. Radiographic Progression Without Corresponding Prostate-specific Antigen Progression in Patients with Metastatic Castration-sensitive Prostate Cancer Receiving Apalutamide: Secondary Analysis of the TITAN Trial. Eur Urol Oncol. 2024 Apr 29:S2588-9311(24)00101-9. doi: 10.1016/j.euo.2024.04.009. Epub ahead of print. PMID: 38688767.
[3] Iwamoto H, Izumi K, Shimada T, Kano H, Kadomoto S, Makino T, Naito R, Yaegashi H, Shigehara K, Kadono Y, Mizokami A. Androgen receptor signaling-targeted therapy and taxane chemotherapy induce visceral metastasis in castration-resistant prostate cancer. Prostate. 2021 Jan;81(1):72-80. doi: 10.1002/pros.24082. Epub 2020 Oct 13. PMID: 33047850.
"
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    string(7) "inherit"
    ["uploaded_to"]=>
    int(15527)
    ["date"]=>
    string(19) "2024-12-23 18:49:45"
    ["modified"]=>
    string(19) "2024-12-23 18:49:45"
    ["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"
  ["human_research_protection_training"]=>
  bool(false)
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(0) {
}


pi affil
array(0) {
}


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


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


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