Randomized Trials in Loco-Regionally Confined Prostate Cancer: Past, Present, and Future.

Over the last 30 years, a vast literature has been published on the available therapeutic approaches for loco-regionally confined prostate cancer. However, it is remarkable how few well designed and well conducted randomized trials have set out to compare them. As a result there is no consensus on the appropriate management of either early stage or locally advanced disease and treatment is still given on the basis of physician preconception, training, and instinct. Published trials have been weakened by the long natural history of prostate cancer and its unpredictable pace. Ten to 15 years are required to fully assess the clinical impact of therapy. By the time of publication, the original therapies frequently have become outmoded or the staging procedures shown to be inadequate by current standards. Prostate-specific antigen is a tumor marker that has powerful prognostic value and detects recurrence long before it becomes clinically apparent. Its use will allow for improved stratification in future studies and shorten the time of follow-up required to assess disease-free survival. Randomized trials will yield results in 5 years rather than the decades previously judged necessary. A renewed emphasis on the randomized trial in prostate cancer is now possible allowing for the rapid and scientific testing of both standard and novel treatment strategies.