On May 5, 2015, Rutgers Cancer Institute of New Jersey was one of seven international sites to offer a clinical trial investigating the surgical removal of the prostate gland (prostatectomy) in addition to as much of the tumor as possible in the surrounding area (debulking) in men newly diagnosed with prostate cancer that has spread to other parts of the body (metastatic). The goal of this immunotherapy study is to see if PROSTVAC improves survival when combined with a drug that helps boost the body’s ability to fight infection.

Results from a previous clinical trial at the Cancer Institute (published in the January 3, 2006 edition of the Journal of Translational Medicine) that examined two forms of PROSTVAC gave researchers information on the safety of using this investigational drug.  This new study will further explore PROSTVAC and examine how well it does in improving survival outcome for metastatic prostate cancer patients.  PROSTVAC-V is derived from a vaccinia virus that was used for many years to vaccinate against smallpox.  PROSTVAC-F is made from the fowlpox virus, which is found in birds and not known to cause any human disease.  Needle injections of both forms of PROSTVAC will be given to some participants.

Some participants also will be given needle injections of a drug called GM-CSF along with PROSTVAC.  GM-CSF is a protein normally made by the body to increase the amount of certain white blood cells and make them more active. When in drug form, it is used to boost the body’s immune system to fight off disease. GM-CSF is already approved by the United States Food and Drug Administration for post-chemotherapy treatment of some cancer patients to help them increase their white blood cell production.

Patients accepted into the study will be selected at random to receive PROSTVAC plus GM-CSF, PROSTVAC plus a GM-CSF placebo, or a PROSTVAC placebo and a GM-CSF placebo.  Participants will take part in the treatment for approximately five months and will undergo study follow-up that includes questionnaires and brief physical exams for approximately five years.

Men aged 18 and older who are diagnosed with metastatic castration-resistant prostate cancer are eligible to take part in the trial, although other criteria must also be met. Prior to being accepted into the study, participants would be required to undergo a number of tests including blood work and a physical exam.