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  ["project_title"]=>
  string(73) "Predictors of survival in metastatic castration-resistant prostate cancer"
  ["project_narrative_summary"]=>
  string(522) "Metastatic castration-resistant prostate cancer (mCRPC) patients generally have an unfavorable prognosis but not all patients have an identical clinical course. While some patients quickly progress to widespread metastatic disease and die of cancer, others have a much more indolent disease progression. Thus, we seek to identify the predictors of time from initial diagnosis of mCRPC to all-cause death. The results of this research will help patients and physicians better determine the prognosis of patients with mCRPC."
  ["project_learn_source"]=>
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  string(63) "New research question to examine factors unrelated to treatment"
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      ["p_pers_f_name"]=>
      string(6) "Daniel"
      ["p_pers_l_name"]=>
      string(7) "Moreira"
      ["p_pers_degree"]=>
      string(7) "MD, MHS"
      ["p_pers_pr_affil"]=>
      string(33) "University of Illinois at Chicago"
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    ["label"]=>
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      ["post_title"]=>
      string(233) "NCT00638690 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy"
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  ["property_scientific_abstract"]=>
  string(1060) "Background: Metastatic castration-resistant prostate cancer (mCRPC) patients generally have an unfavorable prognosis but not all patients have an identical clinical course. While some patients quickly progress to widespread metastatic disease and die of cancer, others have a much more indolent disease progression (1-4).

Objective: We seek to investigate the predictors of time from mCRPC to all-cause mortality.

Study design: Retrospective cohort study

Participants: Men with mCRPC in the placebo arm of A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy.

Main outcome: Overall survival

Secondary outcome: Disease-specific survival, disease progression

Statistical analysis: Survival  will be estimated and plotted using the Kaplan-Meier method. The uni- and multivariable survival predictors will be evaluated with Cox proportional hazards model."
  ["project_brief_bg"]=>
  string(528) "Although metastatic castration-resistant prostate cancer (mCRPC) patients generally have an unfavorable prognosis, not all patients have an identical clinical course (1-4). Indeed, some patients quickly progress to widespread metastatic disease and die of cancer while others have a much more indolent disease progression. Thus, we seek to investigate the predictors of time from mCRPC to all-cause mortality. The results of our study will help physicians and researches stratify mCRPC patients according to their risk of death."
  ["project_specific_aims"]=>
  string(373) "Objective: To determine the predictors of time from metastatic castration-resistant prostate cancer (mCRPC) to all-cause mortality.

Hypothesis: Based on previous reports, we hypothesize that older age at mCRPC, greater number of bone metastasis, higher PSA levels and shorter PSA doubling time at mCRPC will be significantly associated with shorter overall survival."
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  ["project_research_methods"]=>
  string(329) "Data source:  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy.

Inclusion criteria: patients in the placebo arm

Exclusion criteria: missing data"
  ["project_main_outcome_measure"]=>
  string(30) "Main outcome: overall survival"
  ["project_main_predictor_indep"]=>
  string(871) "For this study we will not focus on one single predictors. We seek to determine the variables associated with all-cause mortality. The variables of interest include: included patient?s age at metastatic castration-resistant prostate cancer (mCRPC, continuous, in years), year of mCRPC diagnosis (continuous), patient?s race (black or non-black), treatment center, biopsy Gleason score (2-6, 3+4, 4+3-10 or unknown/not available), localized treatment for PC (none, radical prostatectomy  radiation  ADT, radiation alone  ADT, other), number of bone metastases (1, 2, 3-9, ? 10 or visceral/lymph node metastasis only), metastases to lymph nodes (yes or no), metastases in visceral tissue (yes or no), PSA at mCRPC (continuous and log-transformed, in log[ng/mL]) PSADT at mCRPC (continuous and log-transformed, in log[months]), and PSAV at mCRPC (continuous, in ng/mL/year)."
  ["project_other_variables_interest"]=>
  string(17) "Please see above."
  ["project_stat_analysis_plan"]=>
  string(1652) "Baseline patient and disease characteristics at the time of metastatic castration-resistant prostate cancer (mCRPC) diagnosis will be presented as absolute numbers and percentages, and as median and interquartile range (IQR) for categorical and continuous variables, respectively. Time from mCRPC diagnosis to all-cause death will be evaluated and plotted using the Kaplan-Meier function. The association of patient and disease characteristics with time from mCRPC to all-cause mortality will be evaluated with Cox proportional hazards model in multivariable analysis. Variables considered for the model include patient?s age at mCRPC (continuous, in years), year of mCRPC diagnosis (continuous), patient?s race (black or non-black), treatment center, biopsy Gleason score (2-6, 3+4, 4+3-10 or unknown/not available), localized treatment for PC (none, radical prostatectomy  radiation  ADT, radiation alone  ADT, other), number of bone metastases (1, 2, 3-9, ? 10 or visceral/lymph node metastasis only), metastases to lymph nodes (yes or no), metastases in visceral tissue (yes or no), PSA at mCRPC (continuous and log-transformed, in log[ng/mL]) PSADT at mCRPC (continuous and log-transformed, in log[months]), and PSAV at mCRPC (continuous, in ng/mL/year). The proportional hazard assumption was addressed by examining Schoenfeld residuals of each variable and tested with Grambsch and Therneau?s statistic. All statistical analyses will be performed using Stata 12.1 (StataCorp, College Station, TX) and R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria). A two-sided P < 0.05 will be considered to indicate statistical significance."
  ["project_timeline"]=>
  string(220) "Day 0: Approval of the project

Day 30: Data transfer

Day 60: Data processing (data re-coding/formatting)

Day 90: Data analysis

Day 120: Manuscript writing

Day 180: Manuscript submission"
  ["project_dissemination_plan"]=>
  string(118) "We plan to publish the results of this project in the form of a manuscript in oncology and urology medical journal(s)."
  ["project_bibliography"]=>
  string(1033) "
1. Halabi S, Lin CY, Kelly WK, et al. Updated prognostic model for predicting overall survival in first-line chemotherapy for patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2014;32:671-677.

2. Armstrong AJ, Tannock IF, de Wit R, George DJ, Eisenberger M, Halabi S. The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival. European journal of cancer. 2010;46:517-525.

3. Halabi S, Lin CY, Small EJ, et al. Prognostic model predicting metastatic castration-resistant prostate cancer survival in men treated with second-line chemotherapy. J Natl Cancer Inst. 2013;105:1729-1737.

4. Armstrong AJ, Garrett-Mayer ES, Yang YC, de Wit R, Tannock IF, Eisenberger M. A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: a TAX327 study analysis. Clinical cancer research : an official journal of the American Association for Cancer Research. 2007;13:6396-6403.
"
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products
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