Hormonal therapy is usually reserved for the symptomatic patient with systemic disease. Treatment and prognosis vary dependent upon the stage of cancer. See Table 1 for staging. Although cryosurgery of the prostate was introduced in the early 1960's, inability to control the freezing process led to unacceptable complications and the procedure was quickly abandoned. The present technique as it relates to prostate cancer was developed in the early 1990's.
Local recurrence presents a difficult challenge since there are limited therapeutic options.
Salvage cryotherapy has been increasingly advocated as an additional therapeutic option. These devices are pre-Amendment Class II devices. Because these devices are pre-Amendment, manufacturers of newer systems need only provide data that demonstrate substantial equivalence to a system that is already on the market. These substantial equivalence determinations have been based on functional performance, and have not required clinical data. That is, no human clinical trials were requested by, or submitted to FDA in order to obtain clearance for marketing.