A Phase I Neoadjuvant Study of In-Situ REIC/Dkk-3 Gene Therapy Followed by Prostatectomy in Patients with High Risk of Localized Prostate Cancer (MTG-REIC-PC001)
ID Number 10-0751Principal Investigator(s)
Simon J. Hall
Department(s) or Division(s)
This approach will use gene therapy to turn on the natural cell death process in prostate cancer cells. Cancer cells turn off this natural cell death process and this one of the steps that allows them to grow, divide and potentially spread around the body. The study product is named Ad-hREIC/Dkk-3, which is a virus called Adenovirus that can infect cells and produce a protein called Reduced Expression in Immortalized Cells or REIC for short. The first aim of this study is to determine the highest dose of Ad-hREIC/Dkk-3 that can be safely tolerated by the research study participants. The second aim of the research study is to find out if the toxicity or side effects of producing REIC protein from within cells of the prostate will cause any harmful effects. The study is not designed to give participants a clinical benefit and the treatment will not prevent the need for a radical prostatectomy.
Patients may qualify to take part in this research study if they have been diagnosed with prostate cancer that will be treated with surgery.
Cynthia Knauer RN, CRC
Recruiting Patients: No