A Phase 2, Double-blind, Randomized Controlled Trial of PROSTVAC in Prostate Cancer Patients on Active Surveillance.

ABSTRACT:

Background

There is an unmet clinical need for interventions to prevent disease progression in patients with localized prostate cancer on active surveillance (AS).

Objective

To determine the immunologic response to the PROSTVAC vaccine and the clinical indicators of disease progression in patients with localized prostate cancer on AS.

Design, setting, and participants

This was a phase 2, double-blind, randomized controlled trial in 154 men with low- or intermediate-risk prostate cancer on AS.

Intervention

Participants were randomized (2:1) to receive seven doses of subcutaneous PROSTVAC, a vaccinia/fowlpox viral vector-based immunotherapy containing a prostate-specific antigen (PSA) transgene and three T-cell co-stimulatory molecules, or an empty fowlpox vector

SUBMITTER: Parsons JK 

PROVIDER: S-EPMC10258223 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature