CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 532 enrolled
Drug / intervention
sipuleucel-Tbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03686683
NCT03686683Phase 3Completed
CompareCT.gov

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

Dendreon·interventional·Posted Sep 27, 2018·Updated Oct 8, 2024

In Brief

A Phase 3 clinical trial evaluating sipuleucel-T for Adenocarcinoma of the Prostate. Completed, enrolled 532 participants across 56 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate
CountriesUnited States
CollaboratorsPRA Health Sciences

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 27, 2018
Enrollment StartOct 18, 2018
Primary CompletionMar 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.8 years ago

Interventions

sipuleucel-Tbiological

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).