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Clinical Trials: 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.

 


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.


Trial Focus

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

IRB Protocol #

12-0762

Trial Status

OPEN

Principle Investigator

THOMAS FLAIG

Sponsor

BN Immuno Therapeutics, Inc

Contact

NICOLE CHRONISTER at (720)848-0602 or NICOLE.CHRONISTER@ucdenver.edu

Location

University of Colorado Hospital University of Colorado Hospital

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.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.