Prostate cancer (PCa) is the most commonly diagnosed solid tumor in American men and the second most common cause of cancer death. In 2019, approximately 175,000 men will be diagnosed with PCa, and 32,000 men will die of it; however, most prostate cancers are slow growing, and treatments may negatively impact quality of life due to urinary incontinence or erectile dysfunction. Recent advances in healthcare technology have led to the development of two new treatments. The first, stereotactic body radiation therapy (SBRT), requires five treatment sessions and greater convenience compared with the 45 treatment sessions of conventional radiation therapy. The second, partial gland ablation, also known as focal therapy, is a new treatment approach in which heat (HIFU) or cold (cryoablation) is applied to kill only the part of the prostate known to have cancer. This method differs from traditional treatments that target the entire prostate.
These treatments have been enthusiastically marketed, and there is tremendous need for real-world evidence to inform men about the risks and benefits of these new studies compared with traditional treatment options. The goal of our study is to compare the outcomes of men who undergo contemporary treatments for prostate cancer in both academic and community settings. We engaged multiple stakeholders, including the Food and Drug Administration (FDA), medical device manufacturers, health insurance companies, PCa clinical experts, and, most importantly, PCa survivors, to help design our study. We will compare and track over time complications of treatment and quality-of-life outcomes, such as general health; urinary, sexual, and bowel function; cancer anxiety; and treatment regret. To address these timely and important questions we will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk PCa at high-volume centers in Los Angeles County and New York state. In summary, we have assembled a unique study cohort that includes men from various backgrounds, particularly with the inclusion of ethnically diverse populations.
This is important, as most PCa studies lack outcomes for men of color. Our timely study will inform (1) men and their loved ones about the safety and effectiveness of contemporary treatments for PCa; (2) healthcare providers about comparative outcomes; (3) medical device manufacturers regarding the safety and effectiveness of their technologies; (4) payers about the value of new health technologies; (5) professional guidelines for treatment recommendation; and (6) the FDA regarding the safety and outcomes of SBRT, HIFU and cryoablation, which will be indexed for comparison with new technologies currently seeking FDA approval.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.