To be eligible to participate in this study, a patient must have been diagnosed with prostate cancer that has recurred after completing treatment by external beam radiation therapy or radioactive seed implant. The purpose of this study is to determine therapeutic activity of different concentrations of PRX302 at increasing volumes as well as the safety and tolerance among study subjects after injection into the prostate. The study is expected to enroll 30 subjects.
Protox Therapeutics has received clearance from the FDA to proceed with a Phase IIa clinical trial. According to the company, PRX302, as the agent is currently called, is injected into the prostate where it turns into a potent cell-killing toxin when it comes in contact with PSA (prostate specific antigen)-producing cells.
Scott Coffield, principal investigator at Scott & White, said: “This is an important and exciting step in this process. We are trying to determine if this agent is effective in destroying cancer cells in the prostate using varying doses of the agent, which has demonstrated safety in an earlier trial.”