Prostate cancer is the most common male cancer diagnosis and the second most common cause of death, after lung cancer. Because of its long natural history and steeply increasing incidence with age, it is very prevalent in older men: 3.7% of all men over age 70. As the proportion of older Americans increases, its importance will increase. For most patients with early prostate cancer (Stages A2, B1, B2) equally effective alternative (surgical vs. radiotherapy) treatments with substantially different risk and treatment profiles exist. Nevertheless, there has been little assessment of functional outcomes in treated patients. Further, deviations from accepted standards of care appeared to be common, although decreasing, in the most recent (although outdated) surveys. Finally, the process by which patients and physicians collaborate to choose definitive treatment, needed to design effective interventions to improve treatment decisions, has not been studied. To assess the appropriateness of patient staging and treatment, evaluate patient outcomes and study the process of choosing treatment requires complex but highly interrelated data which is not really available in large databases, such as claims data and registries. Clinical staging determines appropriate treatment and predicts outcome, baseline health and functional status also predict outcomes, and both types of information are likely to affect treatment choices, along with other patient and physician characteristics. This data must be collected specifically for this purpose. However, the development of a large custom database, necessary for meaningful conclusions, is costly. Only essential data should be collected, in the most efficient fashion. We propose a photo study to develop the appropriate methodology and to determine the most important data to be collected for such a special database. We propose to improve our understanding of treatments for early prostate cancer through a multidisciplinary, multi-institutional pilot study of 200 patients with newly-diagnosed early prostate cancer to characterize (1) the appropriateness of staging studies preceding definitive therapy; (2) the variability in treatment choice; and (3) patient functional, psychosocial and psychosexual outcomes six months after treatment, and the factors influencing each of these outcomes. Our study will test the feasibility of collecting highly detailed information from newly diagnosed cancer patients, and will provide descriptive, hypothesis-generating data necessary to design definitive studies of treatment variability, patient decision making, the value of second opinions, and the functional outcomes of treated patients with early prostate cancer.
