PCASP: The Prostate Cancer Active Surveillance Project
Prostate cancer is a major public health problem causing considerable side effects, suffering, death, and healthcare costs. The early treatment of clinically localized disease decreases prostate cancer deaths, but over-treatment of all early-stage patients results in unnecessary adverse side effects without commensurate benefits. Therefore, careful observation, called active surveillance (AS), has emerged as a preferred management strategy for men with early-stage, low-risk prostate cancer. AS has been increasingly adopted in the U.S., but its adoption and implementation are highly variable. There are patients with disease that seems harmless, but may be life-threatening. Delaying treatment in these cases results in the need for very expensive follow-up treatments that have additional adverse side effects. Therefore, an unresolved challenge is to identify which patients should be managed with AS and which with early active treatment.
Prostate cancer also is one of the most genetically determined cancers. Certain genetic variants are associated with disease susceptibility, aggressiveness, and response to different treatments. Hence, genetic studies could fulfill unmet needs for precision medicine by providing better methods of risk-stratifying patients and increasing the knowledge about pathways that could be targeted to customize care. Additionally, new imaging studies including multiparametric MRI scans are being used increasingly but variably in AS programs for risk assessment and to monitor tumor progression. Artificial-intelligence (AI) methods of pathology are being initiated to improve standardization.
The relative long-term costs of AS vs active treatment are unknown. Over-testing, if eliminated, could substantially reduce costs. Avoiding secondary treatments with life-threatening tumors whose treatment has been delayed by a period of AS would greatly reduce costs. Outcome-reporting as now required by the Centers for Medicare and Medicaid Services (CMS) could help develop robust, evidence-based best practices that would improve the quality of patient care and reduce costs.
The Center for Medicare and Medicaid Services (CMS)-required outcomes reporting and the AQUA Registry
CMS requires physicians to report their vetted quality outcomes, and CMS payment for physician services can be increased or decreased, depending upon the quality of care. Physicians must report their outcomes directly or through a certified quality-reporting registry such as the American Urological Association’s (AUA) national AQUA Registry developed for this purpose for subscribing members. The focus of AQUA is that newly diagnosed prostate cancer patients are followed prospectively from time of diagnosis. Their outcomes are evaluated and the quality of the care is assessed. This registry that now includes a very large number of patients and has published relevant outcomes data.
PCASP (the Prostate Cancer Active Surveillance Project) Program Project Grant Proposals
PCASP was conceived and developed in 2016 by Dr. Catalona following preliminary discussions with the National Cancer Institute (NCI). He presented the PCASP concept by invitation at the Foundation of the National Institutes of Health annual Biomarkers Consortium Cancer Steering Committee in 2016 and 2017. In 2018, Dr. Franklin Gaylis (Unio Health Partners, San Diego, California) and he presented the PCASP concept to the Center for Medicare and Medicaid Innovation (CMMI). Dr. Corey Henderson fromCMMI commented, “There is a lot of opportunity here, and I think that the research and work that you have done shows that there is not only passion, but that there is also validity and reliability in the data for success.“ NCI officials suggested that the scope, size, andscientific content of PCASP seemed best studied under a large multi-year, publicly-funded P01 grant. Thus, PCASP is incentive-driven to increase compliance with robust,cost-effective guidelines – in short, better precision care for prostate cancer patients ata lower cost to the health-care system.
PCASP was conceived to be a public-private partnership involving the NIH, AUA, urologists, primary care physicians, radiation oncologists, medical oncologists, pathologists, clinical trialists, implementation scientists, cost-effectiveness experts,geneticists, imaging technology experts, companies with expertise in transfer of big data from the electronic health record (EHR), experts in public health and underserved populations, and industry. The initial PCASP P01 proposals included three interrelated, synergistic projects (1- Implementation and Outcomes of AS, 2 – Genomics, and 3- Relative Cost-Effectiveness of AS Strategies) supported by four cores (1-Administration, 2- Electronic Medical Record Data Extraction, 3-Data Management and Analysis/Biospecimen, and 4- Dissemination.
Future Goals of PCASP
The current adoption and quality of AS in the U.S. remains expensive, extremely variable, and inferior to what is desired. PCASP is now more informed and will focus on implementation science to advance and sustain better outcomes for prostate cancer patients. In keeping with the “Triple Aim” of better care, better health, and lower costs, The PCASP is positioned to empower and support local change agents to accelerate improvement while reducing waste and costs.
PCASP has forged partnerships among academic and community health systems, the AUA, and UnitedHealthCare® (UHC) to develop preliminary data. Like-minded colleagues have come together at regular teleconferences to help grow the safety, improvement, and leadership skills of the health care workforce. The research will advance learning by leading collaborative initiatives that enrich, accelerate, and spread the latest implementation science healthcare improvement ideas and leadership strategies.
PCASP also will incorporate a training program for interprofessional learners to continually develop and increase impact. Collective learning has been leveraged to enhance the power of implementation science. To change ideas, PCASP will employ dissemination science to share practical tools, and improvement measures, publish manuscripts, create white papers, audio and video segments, and other methods. Genomics, magnetic resonance imaging (MRI), and artificial intelligence (AI) pathology will be evaluated to determine their viability in distinguishing between favorable and unfavorable candidates for conservative management strategies.
The Prostate Cancer Active Surveillance Project was first reported in the Summer/Fall 2019 Quest.