BNIT-PRV-301. A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ¦ GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer.

Objective

This is a research study of an investigational new drug called PROSTVAC-V/F which is a vaccine-based, PSA-targeted immunotherapy product which will be injected under the skin. This study hopes to learn more about a new way of potentially treating prostate cancer using a new vaccine that may help cells from your own body to recognize and kill the cancer cells. The study will test how safe it is to receive this vaccine and how well it works in prostate cancer.

IRB Protocol Number

12-0762

Principal Investigator(s)

THOMAS FLAIG

Cancer Trials

• Prostate Cancer

Sponsor(s)

BN Immuno Therapeutics, Inc

Contact

MICHAEL WACKER at 720-848-3427
or MICHAEL.WACKER@UCDENVER.EDU

Eligibility and Other Participant Information

What To Expect : Following a screening period to determine eligibility, the active treatment period for this study will last for approximately 5 months. The full duration of the study will last for approximately five years. Each subject's participation depends on when the subject joins the study. If you decide to participate, you will have to come to the study site every other week for the first 4 weeks (twice), then once a month for four months and then once every six months until the end of the study. // Eligibility criteria include but are not limited to: Male patients 18 years of age and older with Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer.