A Phase 2 Study of IS-002 in People Having Robotic-Assisted Prostate Cancer Surgery

Full Title

Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da VinciTM Surgical System with FireflyTM Fluorescence Imaging

Purpose

The usual approach to robotic-assisted surgery to remove the prostate (radical prostatectomy) is to use white light imaging. This study will see if an imaging agent called IS-002 will help surgeons see and remove cancerous prostate tissue better than just white light imaging during radical prostatectomy.

IS-002 binds to a protein on prostate cancer cells called PSMA. IS-002 glows brightly when exposed to near-infrared light. Near-infrared light plus IS-002 may help identify tissue that contains prostate cancer cells.

The people in this study have prostate cancer. They have chosen to be treated with robotic-assisted surgery to take out the prostate and some tissue around it. If you join this study, you will be randomly assigned to surgery with either:

• IS-002 plus white light imaging and near-infrared light.
• IS-002 with white light imaging only.

Who Can Join

To join this study, there are a few conditions. You must:

• Have prostate cancer that has not spread and will be removed with robotic-assisted surgery.
• Have not received prior prostate cancer treatment.
• Be age 18 to 75.

Contact

For more information or to see if you can join this study, please call Dr. James Eastham’s office at 646-422-4390.