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NCT03686683 · ClinicalTrials.gov registry record · Phase 3
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
A Phase 3 study, sponsored by Dendreon.
- Completed
- Registry status
- Phase 3
- Development phase
- 532
- Enrollment target
NCT03686683: Completed Phase 3 study, sponsored by Dendreon.
NCT03686683 is a Phase 3 study that has completed, run by Dendreon. The registered enrollment target is 532 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03686683, a Phase 3 study, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 532 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR) o Upgrade is defined as participants at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or participants at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher.
Interventions
- BIOLOGICAL sipuleucel-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 3 |
What the finished NCT03686683 record still lists
NCT03686683 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 1 intervention - of which sipuleucel-T is the first listed.
NCT03686683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03686683 about?
NCT03686683 is a clinical study titled "Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer". 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.
What is the current status of trial NCT03686683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 532 participants. The study started on 2018-10-18. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT03686683?
The interventions under investigation include: sipuleucel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT03686683?
This trial is sponsored by Dendreon, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03686683's enrollment target sits among peer trials
532 704th of 2000 higher than 1,297 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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