NC ProCESS: a Stakeholder-Driven, Population-Based Prospective Cohort Study

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): Comparative effectiveness research in early (localized) prostate cancer treatment options is a "highest priority" topic according to the Institute of Medicine and the Agency for Healthcare Research and Quality. Currently, patients and physicians lack the necessary information on potential benefits and harms of modern treatment options (including active surveillance) to make informed decisions, while newer and more expensive treatment technologies become rapidly adopted before research evidence demonstrates their benefit and harms compared to older treatments. Some prior studies have even suggested that newer surgical and radiation treatments could actually cause more side effects than older treatments. Therefore, there is an urgent need for research on modern treatment options to help patients and physicians make treatment decisions, and inform policymakers about the comparative benefits and harms of localized prostate cancer treatment options. The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a population-based cohort of patients who were enrolled within weeks of diagnosis, and followed longitudinally to assess patient-reported outcomes (PRO) and cancer control after different treatments. An initial 3-year funding allowed successful recruitment of thi large and diverse cohort from 2011-2013, using a unique NC Cancer Registry system enabling all patient enrollment prior to treatment, important to minimize potential biases in enrollment and data collection (especially PRO). This current proposal will assess patient outcomes at 5-6 years' follow-up, providing timely and currently unavailable information to patients, physicians, and policymakers. This current study is essential to yield meaningful results from this rich cohort, achieve the specific aims (below) and test hypotheses on the comparative effectiveness among different treatment options. NC ProCESS was designed in collaboration with stakeholders including patients, who will continue to advise the investigators throughout the study and will help with interpreting the study results and dissemination. The Specific Aims include: Aim 1: To directly compare patient-reported prostate-cancer specific and global quality of life (QOL), anxiety regarding prostate cancer and decisional regret within 5 years of follow-up in a cohort of men with localized prostate cancer managed by active surveillance, open radical prostatectomy, minimally-invasive radical prostatectomy, intensity-modulated radiation therapy, and brachytherapy. We will explore comparisons with stereotactic radiation therapy and proton therapy. Aim 2: To directly compare freedom-from cancer recurrence (FFCR) within 6 years of follow-up among different options. The multidisciplinary team of investigators has extensive experience in prostate cancer research, and results from this study will significantly advance the field of localized prostate cancer comparative effectiveness research, and improve the care of patients with this common disease. A national group of stakeholders will help disseminate significant study findings to patients throughout the US, physicians, and policymakers.