Prostate cancer is the most common solid tumor and is the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that """"""""no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects."""""""" The existing literature is limited by its focus on older therapeutic modalities and by failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators. By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims: 1. To compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in the cohort described above in terms of the 6- and 12-month patient-reported outcomes, side-effects and complications of treatment;2. To identify patient level characteristics that may influence comparative effectiveness;and 3. To assess how the comparative effectiveness of the various therapies varies by quality of care received.

Public Health Relevance

This study will compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect outcomes. By figuring out what treatments """"""""work best, in which patients and in whose hands"""""""", we will help men with prostate cancer make better decisions regarding their care.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
1R01HS019356-01
Application #
8009296
Study Section
Special Emphasis Panel (ZHS1-HSR-C (01))
Program Officer
Lawrence, William
Project Start
2010-09-01
Project End
2013-08-31
Budget Start
2010-09-01
Budget End
2013-08-31
Support Year
1
Fiscal Year
2010
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Surgery
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
Tyson 2nd, Mark Douglas; Koyama, Tatsuki; Lee, Dan et al. (2018) Effect of Prostate Cancer Severity on Functional Outcomes After Localized Treatment: Comparative Effectiveness Analysis of Surgery and Radiation Study Results. Eur Urol 74:26-33
Barocas, Daniel A; Alvarez, JoAnn; Resnick, Matthew J et al. (2017) Association Between Radiation Therapy, Surgery, or Observation for Localized Prostate Cancer and Patient-Reported Outcomes After 3 Years. JAMA 317:1126-1140
Eifler, J B; Alvarez, J; Koyama, T et al. (2017) More Judicious Use of Expectant Management for Localized Prostate Cancer during the Last 2 Decades. J Urol 197:614-620
Tyson, Mark D; Alvarez, JoAnn; Koyama, Tatsuki et al. (2017) Racial Variation in Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Results from the CEASAR Study. Eur Urol 72:307-314
Lang, Maximilian F; Tyson, Mark D; Alvarez, JoAnn Rudd et al. (2017) The Influence of Psychosocial Constructs on the Adherence to Active Surveillance for Localized Prostate Cancer in a Prospective, Population-based Cohort. Urology 103:173-178
O'Neil, Brock; Koyama, Tatsuki; Alvarez, JoAnn et al. (2016) The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples. J Urol 195:321-9
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Resnick, Matthew J; Barocas, Daniel A; Morgans, Alicia K et al. (2015) The Evolution of Self-Reported Urinary and Sexual Dysfunction over the Last Two Decades: Implications for Comparative Effectiveness Research. Eur Urol 67:1019-1025
Resnick, Matthew J; Barocas, Daniel A; Morgans, Alicia K et al. (2014) Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment. Cancer 120:1263-71
Ark, Jacob T; Keegan, Kirk A; Barocas, Daniel A et al. (2014) Incidence and predictors of understaging in patients with clinical T1 urothelial carcinoma undergoing radical cystectomy. BJU Int 113:894-9

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