This phase 2 trial will investigate the safety and effectiveness of a prostate cancer vaccine. The main outcome will be the rate of prostate cancer progression.
The details
Prostate cancer (PC) is cancer the originates in the prostate gland (PG). PC is very common, however, most men will recover from it. The progression of PC is usually very slow. Proscavax is a vaccine that may prevent the progression of PC. It contains two factors that activate an immune response to the cancer. The factors are interleukin-2 (Il-2) and granulocyte-macrophage-colony-stimulating factor (GM-CSF). It may slow progression by stimulating the immune system to attack cancer cells.
This trial will investigate the safety and effectiveness of a Proscavax. The main outcome will be the rate of prostate cancer progression.
Who are they looking for?
This study will recruit 120 patients with PC. Participants must have clinically localized PC. This means the cancer can not have spread to other areas. Other inclusion criteria include no previous PC treatment, adequate blood cell counts and kidney, and liver function tests. Participants with female partners that are able to become pregnant must use effective contraception.
Patients cannot take part in the trial if they have a history of other cancers. Patients that are immuno-compromised, who have heart disease or autoimmune disorder cannot take part in the study.
How will it work
Patients will be randomly assigned to one of two groups. In the treatment group, patients will receive the vaccine. It will be administered in 6 doses, under the skin. This will be done over a 4-month period.Booster injections will be given once a month. A dose of Il-2 and Proscavax will be given alternately each month. For example in week 19 a booster injection of IL-2 will be given. In week 23, Proscavax will be given. The treatment phase will last 6 months. Patients in the control group will not have any intervention. All patients will be assessed every 3 months for 2 years.
The main outcome will be the rate of cancer progression.
