Prostate cancer is the third most common cancer, accounting for one in 10 cancer diagnoses in men worldwide during 2000. Despite this high burden of morbidity, there is a lack of curative treatments for locally advanced and metastatic disease. Good anatomical accessibility of the prostate combined with substantial molecular understanding of the disease makes prostate cancer an attractive target for gene therapy. Considerable progress has been made in the development of suitable gene transfer vectors and prostate-targeting strategies. Therapeutic approaches being explored fall into two broad categories: corrective and cytoreductive/cytolytic. There are currently 63 prostate cancer gene therapy clinical trials based on these approaches registered in the United States and United Kingdom. Although significant hurdles remain to be overcome, early clinical trial results are encouraging, suggesting that gene therapy may become an important treatment option for prostate cancer.