PHASE I TRIAL OF PDT IN PATIENTS WITH PROSTATE CARCINOMA

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DESCRIPTION: (Applicant's Description) The broad, long-term objective of this proposal is to develop photodynamic therapy as a local treatment for patients with prostate cancer. The Specific aims are: (1) to determine the doselimiting toxicities and maximally tolerated dose of Lutetium texaphyrin-mediated photodynamic therapy (PDT) in patients with recurrent prostate cancer, (2) to make direct tissue measurements of Lutetium texaphyrin in biopsies of the prostate before and after PDT, and (3) to measure Lutetiurn texaphryin levels in the prostate with in situ fluorescent (optical) methods and to compare these results with direct tissue measurements. The research design is a Phase I, dose escalation clinical trial of PDT using Lutetium texaphyrin and 730 nm light in patients with recurrent prostate cancer who have failed radiotherapy. Lutetium texaphyrin will be given intravenously prior to light delivery. Light delivery will be achieved using fibers inserted interstitially via a perineal template in the operating room and the dose will be monitored using an on-line dosimetry system. Direct measurements of Lutetium texaphyrin will be made in prostate biopsy specimens using tissue fluorescence and high pressure liquid chromatography.