The introduction of prostate-specific antigen (PSA) testing for use in the early detection of prostate cancer has led to controversy regarding the appropriateness of prostate cancer screening and any resulting treatment. This controversy is in part due to the fact that the effect of early treatment of prostate cancer on mortality rates is not known. Other cancer screening programs, however, such as breast and cervical cancer were implemented without knowledge of the effect of such screening on mortality rates. In fact, proof of the efficacy of these other screening programs was based on their widespread use in the community and not on controlled, randomized trials. One critical difference between these other cancer screening programs and prostate cancer screening is that prostate cancer screening has become available at a time when cost control is a dominant concern in the health care system. The rising cost of health care has made payers (employers, insurance companies, and federal and state governments) less willing to approve new benefits for their members.

American companies now are forced to compete globally with foreign corporations. The relatively high cost of health care for American businesses has decreased productivity and hampered their ability to compete internationally. The rising cost of health care also has placed a burden on federal and state governments. Ever-increasing budget deficits and the contribution of the rising costs of Medicaid and Medicare to these deficits have compelled governments to better control their health care costs.

Regardless of the present health care environment, the cost of care must always be considered. Very few interventions in medicine offer actual cost savings. Most add cost and, it is hoped, provide a reasonable benefit to patients. Supplying endless “cost-effective” interventions could conceivably bankrupt our government and businesses. Patients, whether they are young or old, curable or incurable, afflicted with cancer or benign disease, have always competed for health care resources. Today they are competing for more limited resources as cost-control efforts intensify.

In the current health care marketplace, proof of efficacy and cost-effectiveness are central requirements for the implementation of new medical interventions. Practitioners must decide whether the dollars spent on a new intervention such as prostate cancer screening are worth the benefits (in terms of increased survival or improved quality of life) compared with alternative uses of the same dollars for established interventions. The cost and benefits of prostate cancer screening and subsequent treatment can be definitively determined only by controlled, randomized trials with long-term follow-up. Until such studies become available, doctors and patients must make decisions regarding the appropriateness of prostate cancer screening based on currently available evidence. This article reviews the possible effect on total health care costs of widespread PSA screening, and follows with a review of several studies that have attempted to define the effectiveness and cost-effectiveness of PSA screening and treatment.