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NCT01431391 · ClinicalTrials.gov registry record · Phase 2
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
A Phase 2 study, sponsored by Dendreon.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT01431391: Completed Phase 2 study, sponsored by Dendreon.
NCT01431391 is a Phase 2 study that has completed, run by Dendreon. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431391, a Phase 2 study, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
Primary Outcome
Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.
Interventions
- DRUG leuprolide acetate
- BIOLOGICAL sipuleucel-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01431391 record still lists
NCT01431391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which leuprolide acetate is the first listed.
NCT01431391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431391 about?
NCT01431391 is a clinical study titled "Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer". The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in pros...
What is the current status of trial NCT01431391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2011-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01431391?
The interventions under investigation include: leuprolide acetate (DRUG), sipuleucel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01431391?
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 NCT01431391's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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