Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer — ProVent  

Adenocarcinoma of the Prostate Clinical Trial

Official title: A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

Status Active, not recruiting

Clinical Trial Summary

The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to subjects followed on active surveillance as standard of care.

Clinical Trial Description

The ProVent Study is designed to look at subjects who recieve sipuleucel-T compared to control subjects followed on AS. The study will enroll subjects being followed by AS and initially diagnosed within 12 months prior to Screening with either ISUP Grade Group 1 or 2 adenocarcinoma of the prostate.

The Screening Phase will begin at the completion of the informed consent process and continues until randomization. After Screening assessments are completed, eligible subjects will be randomized 2:1 to the sipuleucel-T arm or the control arm. Subjects randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label.

Subjects will undergotheir first leukapheresis within 60 days of randomization.

Subjects randomized to the control arm will be followed on AS. The Active Phase will begin at randomization and continues through completion of the end of Active Phase study visit (within 30 days of Biopsy 2). Once a subject from either the sipuleucel-T or control arms completes the end of Active Phase visit, they will enter the Follow-up Phase and complete Follow-up Phase visits every 6 months starting from their last Active Phase visit. The Follow-up Phase visits end when the last subject enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

• NCT number: NCT03686683
• Study type: Interventional
• Source: Dendreon
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 18, 2018
• Completion date: February 28, 2024