Prostate Cancer Clinical Trial
Official title:
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they start treatment, and are then followed prospectively through treatment and then afterwards. This observational study collects information on quality of life, cancer control, and health care received inclusive of treatment and management of subsequent effects including complications and recurrence. The objective of this study is to examine comparative outcomes among different modern prostate cancer treatment options in this cohort of patients.
Localized prostate cancer treatment options is consistently a "highest priority" comparative
effectiveness research (CER) topic according to the Institute of Medicine, Agency for
Healthcare Research and Quality (AHRQ), and other summary reports. Patients urgently need
information on the comparative outcomes of modern treatment options to guide decision-making
for this disease that causes significant burden based on its high prevalence, mortality and
treatment effects on quality of life. The status quo as it pertains to prostate cancer is
significant overtreatment causing potential patient harm, rapid diffusion of new/expensive
technologies without proven benefit and patients lacking high quality research evidence to
balance direct-to-consumer advertising and guide individualized decision-making.
NC ProCESS is a population-based cohort designed specifically to address well-described
knowledge gaps. It was designed in close collaboration with the unique AHRQ consortium
stakeholder group, which included representatives from patients, clinicians and policymakers.
Stakeholders helped define study design to emphasize "real-world" patients and select
patient-centered and relevant outcomes, and have been involved throughout assembly of this
patient cohort. The diverse cohort is well-represented by "hard to reach" patients;
enrollment before treatment avoids biases with participation and recall. As clinical trials
are not feasible to address the central questions in prostate cancer CER, this prospective
study will yield the highest level of evidence to inform patients and other stakeholders.
With an assembled cohort, this study is necessary to examine comparative outcomes.
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