PHASE I TRIAL OF PDT IN PATIENTS WITH PROSTATE CARCINOMA

描述：（申请人的描述） 这项提案的广泛的长期目标是开发光动力学 前列腺癌的治疗方法有哪些？ 具体 目的是：（1）确定剂量限制性毒性， 耐受剂量的克萨卟啉镥介导的光动力疗法（PDT）， 复发性前列腺癌患者，（2）制作直接组织 前列腺活检前和后前列腺活检中得克萨斯卟啉镥的测定 PDT后，和（3）测量前列腺中的Lutetiumtexaphryin水平， 原位荧光（光学）方法，并将这些结果与直接 组织测量。 研究设计为I期，剂量递增 应用克萨卟啉和730 nm光进行PDT的临床试验 放疗失败的复发性前列腺癌患者 镥 德克萨卟啉将在光递送之前静脉内给予。 光 通过会阴插入纤维 在手术室的模板和剂量将使用在线监测 剂量测定系统 直接测量得克萨斯卟啉镥将在 使用组织荧光和高压液体的前列腺活组织检查标本 层析

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.