The CaPSURE database: a methodology for clinical practice and research in prostate cancer. CaPSURE Research Panel. Cancer of the Prostate Strategic Urologic Research Endeavor.

OBJECTIVES

Implicit in the modern concept of patient outcome assessment is a shift from primary reliance on clinical indicators to a broader definition that includes physical, psychological, and social well-being. This is especially true of prostate cancer, where treatment can profoundly alter patient well-being. We have initiated a longitudinal observational database, CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) to document the impact of prostate cancer on resource utilization, clinical outcomes, health-related quality of life and survival in typical practice settings.

METHODS

Observational databases have been used in the treatment of other conditions. We have incorporated many well-tested elements in our study. Data are collected from two sources: the physician and the patient. The urologist enrolls eligible patients into the study, completes a medical history, and records current status, treatment, and laboratory results at each office visit. Patients complete quarterly questionnaires on health-related quality of life, resource utilization, work loss, and satisfaction with care.

RESULTS

Currently 21 sites participate in CaPSURE with 1419 patients enrolled by April 1996. Twenty percent of patients are newly diagnosed with prostate cancer. Time since diagnosis averages 3.0 years (SD = 3.1); mean age at diagnosis is 68.9 years (SD = 7.9, range = 39.6 to 90.7). The majority of patients (72%) are diagnosed with Stage B cancer. Patients receive a variety of treatments including surgery, irradiation, hormonal therapy, and watchful waiting.

CONCLUSIONS

Information available from CaPSURE will assist practicing urologists who must make clinical decisions on the basis of data such as the results of treatment in typical care settings, the effect of prostate cancer and its treatment methods on patient quality of life, and the effect on health care costs of the early detection of prostate cancer.