Prostate SPORE Project 3

Gene Therapy of Prostate Cancer Using Radioactive Iodine

Principal Investigator: John C. Morris, III, M.D.

The specific aims of Project 3 are to:

• Evaluate the safety and maximum tolerated dose level of AD5-CMV-NIS as an adenoviral construct for radioiodine treatment as well as obtain
  preliminary data on clinical outcome in the context of a Phase I clinical trial in patients with locally recurrent prostate cancer following radiation therapy failure. Upon completion of this trial, we will more formally evaluate the efficacy of this treatment regimen at the recommended dose level through a phase II trial.
• Develop a second generation adenoviral construct that is specific for prostate tissue, Ad-Pb-NIS, for clinical trial in prostate cancer and
  evaluate the safety and maximum tolerated dose level of this adenoviral construct as well as obtain preliminary data on clinical outcome through a phase I clinical trial.
• Develop and evaluate different constructs for enhanced and systemic delivery of NIS for metastatic prostate cancer.