Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

Summary

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

Timeline

Start

2019-02-28

Primary completion

2021-02-28

Completion

2022-06-30

Drugs

Indications