Biological principles and clinical development of prostate cancer gene therapy.

Several clinical trials of prostate cancer gene therapy are underway. The therapeutic genes being evaluated by these and other, forthcoming, trials include immunogenes, cell death-inducing genes, antioncogenes, and tumor suppressor genes. Constraints of current gene transfer vectors limit, to local-regional targeting, those gene therapy strategies that do not rely on an intervening immune response. Preclinical models predict modest, if any, therapeutic effects with current forms of prostate cancer gene therapy. Using biological surrogate endpoints and applying further preclinical advances will allow clinical prostate cancer gene therapy to attain its full potential.