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

Prostate Cancer Clinical Trial

Official title: A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naive Patients With Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This study will have 2 arms and patients will be randomized 2:1 into the Proscavax treatment arm (Arm 1) versus the active surveillance arm (Arm 2).

In study Arm 1, 6 doses of the vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.

In study Arm 2, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03579654
• Study type: Interventional
• Source: OncBioMune Pharmaceuticals
• Contact: Rupal S Bhatt, MD, PhD
• Phone: (617) 735-2062
• Email: rbhatt@bidmc.harvard.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 28, 2019
• Completion date: June 30, 2022