Ad5CMVp53 gene therapy for locally advanced prostate cancer - where do we stand?

Despite the introduction of screening procedures and an increased public aw areness of prostate cancer, a substantial number of patients present with l ocally advanced prostate cancer. Traditional therapies (such as radiation t herapy or radical prostatectomy) applied either alone or in combination fai l to control local disease in a large number of cases and have no effect on disseminated disease. Recent advances in molecular oncology and genetics h ave led to such novel therapies as p53 gene therapy, which we are currently evaluating in a clinical protocol in patients with locally advanced (nonme tastatic) prostatic cancer. Ad5CMVp53 (RPR/INGN 201) has previously shown p romise in both patients with lung cancer and those with head and neck cance r. The traditional end points used to appraise prostate cancer preclude rap id evaluation of the patient's disease and prevent modification of the ther apeutic strategy, and we suggest that the pathologic stage after therapy be evaluated as an intermediate end point.