This application addresses broad challenge Area (05) Comparative Effectiveness Research (CER) and the specific Challenge Topic, 05-CA-104: Comparative Effectiveness of Research on Cancer Treatment. Prostate cancer is the most common malignancy in men, with an estimated 186,000 new cases diagnosed in the US in 2008. Radical prostatectomy (RP) by open or minimally invasive techniques is the most common treatment for localized prostate cancer. However, evidence-based medicine has not established the benefit of these different treatment options. Despite the paucity of data on perioperative and oncologic outcomes of the minimally invasive technique, its use has increased exponentially. There is also limited information on cost differences between open (ORP) and minimally invasive radical prostatectomy (MRP), and the available literature fails to account for patient out-of-pocket expenditures. Given the large number of men affected and the costs associated with surgical treatment, these public-health issues warrant investigation. Although a randomized comparison of MRP and ORP is unlikely to occur because of accrual difficulty, large population-based data sets can provide a valuable resource for comparative effectiveness studies. This study proposes to compare surgical treatment options for localized prostate cancer (MRP versus ORP) in terms of perioperative outcomes and cost, using several large national data resources and prospectively collected data from a large-volume specialty cancer center.
Specific Aim 1 is to compare perioperative outcomes, complications, and direct medical costs between RP surgical techniques in a population-based observational cohort of men treated with RP for localized prostate cancer (taken from the Surveillance, Epidemiology and End Results (SEER) population-based cancer registry linked with Medicare claims database). The outcomes for comparison include 90-day postoperative morbidity and mortality, length of hospital stay, late urinary and bowel complications, treatment of incontinence, use of postoperative radiation or androgen deprivation therapy, and direct medical costs. Multivariable methods will be used to compare outcomes between groups, adjusting for sociodemographic and clinical covariates. The cost comparison between RP surgical techniques will be accomplished by totaling all Medicare payments made within one year of surgery.
Specific Aim 2 is to identify and compare medical, nonmedical, and indirect costs following ORP and MRP in a prospective cohort of RP patients. For this aim, we will prospectively identify and compare such costs in a cohort of RP patients from a large-volume, comprehensive cancer center. Data for this portion of the study will come from an electronic medical record and clinical research database (Caisis) and from a survey administered at specific intervals. The survey will focus on expenses related to home care during recovery, incontinence or erectile dysfunction, and inability to return to work.
Prostate cancer is the most common cancer in American men and there is a substantial economic burden associated with surgical removal of the prostate gland (radical prostatectomy), the most common treatment for prostate cancer that has not spread to other tissues. There are various surgical approaches for treating prostate cancer, but unfortunately few high-quality studies have compared the different techniques. Better comparisons of complications, outcomes, and costs between minimally invasive and open radical prostatectomy would assist patients, physicians, and health care policy makers in treatment decisions, resulting in better patient care and potentially lower costs.
