NCT03686683

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Dendreon · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 participants followed on active surveillance as standard of care.

Detailed description

The ProVent Study is designed to look at participants who receive sipuleucel-T compared to control participants followed on active surveillance (AS). The study will enroll participants being followed by AS and initially diagnosed within 12 months prior to Screening with either International Society of Urological Pathology (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 participants will be randomized 2:1 to the sipuleucel-T arm or the control arm. Participants randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label. Participants will undergo their first leukapheresis within 60 days of randomization. Participants 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 Participant 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 Participant enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
BIOLOGICAL	sipuleucel-T	Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with recombinant fusion protein composed PAP linked to GM-CSF (PA2024), a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Timeline

• Start date: 2018-10-18
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2018-09-27
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

56 sites across 1 country: United States

Regulatory

• FDA-regulated drug study