Cell Preservation Services Inc. (CPSI) is a biotechnology corporation focused on developing new and innovative approaches to the use of chilling and freezing temperatures in support of the cell therapy and cancer arenas. In the former, CPSI studies stress pathways activated during hypothermic storage (4C) and cryopreservation (-196) so that improved preservation solutions can be formulated. These solutions, sold by CPSI's marketing partner BioLife Solutions Inc., are used in FDA-approved cell therapy IND'S. These same data on stress pathways are also being used to potentiate cell death in cancer cells during ablative freezing processes - a regime that couples traditional cryosurgery with adjuvant (e.g. 5-FU, cisplatin) treatments. This approach has recently led to the initiation of a physician sponsored IND for the treatment of advanced stage prostate cancer. This Phase I project proposes to develop a novel therapeutic cryosurgical device (CryoInject(tm)) for treating recurrent prostate cancer. The reasoning behind the development of the system are as follows: (1) The CryoInject(tm) will be a hand held device allowing for ease of application; (2) It will incorporate the CryoPellet(tm) technology (frozen low dose chemotherapeutic pellets) applied in specific locations of the diseased area; (3) The application of will initially be intended as a salvage therapy tool for treating prostate cancer and; (4) the utilization of this device may also be an effective nerve-sparing procedure. The Specific Aims of the Phase 1 are: SA1 - Identify which cryogen is best suited for "CryoPellet(tm)" design; SA2 - Determine the efficacy and feasibility of the "CryoPellet(tm)"; SA3 - Design a prototype CryoInjectTM System; SA4 - Test the efficacy of the CryoPellet(tm) and CryoInjectTM System during cryosurgery. Successful completion of Phase I and 2 will lead to the development of the CryoInject(tm) system which can then be used as an alternative and effective salvage treatment option for prostate cancer. Once developed and tested, the system may become useful as an alternative treatment for prostate cancer as well as an alternative method for treating renal and liver cancers. Consequently, this novel therapeutic design will provide a major benefit to the clinical area as well as provide a platform for future development of minimally invasive therapeutic regimes for the treatment of cancer. The intent of this project is to investigate and develop a novel therapeutic device (CryoInjectTM and CryoPelletTM) for treating prostate cancer. The device will be used to apply freezing temperatures (cryoablation) to destroy unwanted tissue. [unreadable] [unreadable] [unreadable]