Quality of life considerations are becoming increasingly important in prostate cancer management, particularly with the trend for patients to be diagnosed at an earlier age and at an earlier stage of disease. A rising serum prostate-specific antigen (PSA) level in the absence of symptoms can cause anxiety to many patients. Patients in this situation must weigh the benefits of treatment, such as delay in time to progression and increased time without pain, against the onset of adverse events that may affect quality of life. Traditionally, the active treatment options for locally advanced disease, following either new diagnosis or failure of treatment of primary curative intent, are radiotherapy and castration (medical or surgical). Radiotherapy may affect sexuality and bowel functioning, and castration is particularly associated with loss of libido and sexual dysfunction. Studies have shown that treatment-associated side effects extending over many years are of great concern to many patients. Therefore, for treatments with similar outcomes in terms of survival or time to progression, there is good reason to consider introducing new measures of efficacy based on quality of life endpoints. Data from two large studies of bicalutamide ('Casodex') therapy in patients with locally advanced prostate cancer show that this non-steroidal antiandrogen is not only associated with comparable survival outcomes but significant health-related quality of life benefits, compared with castration. In addition, a large early prostate cancer trial has demonstrated that bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. Moreover, bicalutamide treatment was associated with fewer adverse events relating to sexual function. The risk of treatment-related side effects or influence on the total quality of life must be considered carefully for each individual patient in order to assess the most appropriate treatment option. Copyright (C) 2001 S. Karger AG, Basel.