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NCT00065442 · ClinicalTrials.gov registry record · Phase 3
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
A Phase 3 study, sponsored by Dendreon.
- Completed
- Registry status
- Phase 3
- Development phase
- 512
- Enrollment target
NCT00065442: Completed Phase 3 study, sponsored by Dendreon.
NCT00065442 is a Phase 3 study that has completed, run by Dendreon. The registered enrollment target is 512 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065442, a Phase 3 study, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 512 participants
- Enrollment target
Study Summary
Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them. Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study. If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.
Primary Outcome
Time from randomization until death due to any cause.
Interventions
- BIOLOGICAL Sipuleucel-T
- BIOLOGICAL APC-Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2003-07 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00065442 record still lists
NCT00065442 is an interventional study that assigns participants to a tested intervention. The registered 512 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 (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Sipuleucel-T is the first listed.
NCT00065442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00065442 about?
NCT00065442 is a clinical study titled "Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy". Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them. Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 l...
What is the current status of trial NCT00065442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 512 participants. The study started on 2003-07. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00065442?
The interventions under investigation include: Sipuleucel-T (BIOLOGICAL), APC-Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00065442?
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 NCT00065442's enrollment target sits among peer trials
512 728th of 2000 higher than 1,273 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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