Among men, prostate cancer is the most common non-skin cancer. Although the majority of prostate cancer patients are over 65 years of age, outcomes data specific to elderly patients are sparse. This proposal addresses a pressing public health issue: What are the long-term clinical outcomes of the ever-increasing number of elderly patients with localized prostate cancer? This study will focus on outcomes following conservative management and primary androgen deprivation therapy (PADT), the second most common treatment among elderly men despite the absence of data supporting its application. The importance of determining the appropriate use of PADT has increased in urgency because a growing body of literature now demonstrates that ADT use is associated with substantial side effects and healthcare costs. The Institute of Medicine has identified assessment of treatment for localized prostate cancer as a top research priority in its recent comparative effectiveness research priorities report. During the initial funding period we found that survival outcomes have improved substantially over time and early use of PADT was not associated with improve cancer-specific or overall survival for the majority of elderly men with localized prostate cancer. These findings have been cited in numerous treatment guidelines. The major limitations of our initial investigation were limited follow-up and unavailability of key prognostics factors such as detailed Gleason scores and baseline prostate specific antigen (PSA) data. To address these limitations we are proposing a continuation study to provide longer follow-up data and refined outcome estimates incorporating newly available PSA and detailed Gleason scores. This population-based study will use SEER-Medicare linked data (1992 - 2011) to identify study subjects and cancer treatment history. The large sample size (N ~ 66,000) will provide ample statistical power. We will utilize modern methods designed to minimize biases. When complete, this proposed study will provide the largest and longest follow-up data (up to 19 years) on survival and on use of major interventions for cancer complications among elderly men with localized prostate cancer. Our updated data will help clarity any misconception about the potential benefit of PADT, thereby facilitating informed decision-making, decreasing inappropriate treatment, and thus reducing healthcare expenditures while improving quality of life for millions of men.

Public Health Relevance

Over 167,000 men are diagnosed annually with cancer confined to the prostate. Lack of unbiased, representative outcomes data is a major barrier in deciding upon the best course of clinical management. This study aims to fill the knowledge gap to facilitate informed decisions.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA116399-06
Application #
8325501
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Warren, Joan
Project Start
2005-09-01
Project End
2014-11-30
Budget Start
2012-01-01
Budget End
2012-12-31
Support Year
6
Fiscal Year
2012
Total Cost
$220,467
Indirect Cost
$79,142
Name
University of Medicine & Dentistry of NJ
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
617022384
City
Piscataway
State
NJ
Country
United States
Zip Code
08854
Lu-Yao, Grace L; Albertsen, Peter C; Moore, Dirk F et al. (2014) Fifteen-year survival outcomes following primary androgen-deprivation therapy for localized prostate cancer. JAMA Intern Med 174:1460-7
Shao, Yu-Hsuan; Moore, Dirk F; Shih, Weichung et al. (2013) Fracture after androgen deprivation therapy among men with a high baseline risk of skeletal complications. BJU Int 111:745-52
Shao, Y-H; Albertsen, P C; Shih, W et al. (2011) The impact of PSA testing frequency on prostate cancer incidence and treatment in older men. Prostate Cancer Prostatic Dis 14:332-9
Albertsen, Peter C; Moore, Dirk F; Shih, Weichung et al. (2011) Impact of comorbidity on survival among men with localized prostate cancer. J Clin Oncol 29:1335-41
Roberts, Calpurnyia B; Albertsen, Peter C; Shao, Yu-Hsuan et al. (2011) Patterns and correlates of prostate cancer treatment in older men. Am J Med 124:235-43
Shao, Yu-Hsuan; Albertsen, Peter C; Roberts, Calpurnyia B et al. (2010) Risk profiles and treatment patterns among men diagnosed as having prostate cancer and a prostate-specific antigen level below 4.0 ng/ml. Arch Intern Med 170:1256-61
Yao, Siu-Long; Lu-Yao, Grace L (2010) Diagnosis of localized, screen-detected, prostate cancer--crisis or opportunity? J Natl Cancer Inst 102:919-20
Lu-Yao, Grace L; Albertsen, Peter C; Moore, Dirk F et al. (2009) Outcomes of localized prostate cancer following conservative management. JAMA 302:1202-9
Shao, Yu-Hsuan; Demissie, Kitaw; Shih, Weichung et al. (2009) Contemporary risk profile of prostate cancer in the United States. J Natl Cancer Inst 101:1280-3
Parekh, Niyati; Lin, Yong; Marcella, Stephen et al. (2008) Associations of lifestyle and physiologic factors with prostate-specific antigen concentrations: evidence from the National Health and Nutrition Examination Survey (2001-2004). Cancer Epidemiol Biomarkers Prev 17:2467-72

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