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NCT00779402 · ClinicalTrials.gov registry record · Phase 3
PROvenge Treatment and Early Cancer Treatment
A Phase 3 study of Prostate Cancer, sponsored by Dendreon.
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
- 18
- Study locations
NCT00779402: Completed Phase 3 study of Prostate Cancer, sponsored by Dendreon.
NCT00779402 is a Phase 3 study of Prostate Cancer that has completed, run by Dendreon. The registered enrollment target is 176 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00779402, a Phase 3 study of Prostate Cancer, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
- 18
- Study locations
Study Summary
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The study compared the active vaccine to control to determine whether the product delayed the time until cancer progression.
Primary Outcome
Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL
Conditions Studied
Interventions
- OTHER Control
- BIOLOGICAL Sipuleucel-T
Study Locations (18)
Oregon
- Providence Medical Center - Portland
- Oregon Health and Sciences University - Portland
- Oregon Urology Institute - Springfield
Pennsylvania
- Urology Health Specialists - Bryn Mawr - Bryn Mawr
- Albert Einstein Medical Building - Philadelphia
- Bryn Mawr Urology Group - Rosemont
California
- Alta Bates Comprehensive Cancer Center - Berkeley
- South Orange County Medical Research - Laguna Hills
New York
- Mount Sinai School of Medicine - New York
- University of Rochester Medical Center - Rochester
Washington
- Virginia Mason Medical Center - Seattle
- Swedish Medical Center - Seattle
Colorado
- University of Colorado Health Sciences Center - Aurora
Illinois
- Oncology Specialists, SC - Park Ridge
North Carolina
- McKay Urology - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2001-10 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT00779402 record still lists
NCT00779402 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT00779402 lists 18 locations in 11 states (Oregon, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT00779402 about?
NCT00779402 is a clinical study titled "PROvenge Treatment and Early Cancer Treatment". The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment...
What is the current status of trial NCT00779402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2001-10. Estimated completion is 2015-05.
What conditions does trial NCT00779402 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00779402?
The interventions under investigation include: Control (OTHER), Sipuleucel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT00779402?
This trial is sponsored by Dendreon, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00779402 being conducted?
This trial has 18 study locations across California, Colorado, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00779402's enrollment target sits among peer trials
176 244th of 735 higher than 492 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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