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NCT01322490 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
A Phase 3 study of Prostate Cancer Metastatic, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,297
- Enrollment target
- 20
- Study locations
NCT01322490: Completed Phase 3 study of Prostate Cancer Metastatic, sponsored by Bavarian Nordic.
NCT01322490 is a Phase 3 study of Prostate Cancer Metastatic that has completed, run by Bavarian Nordic. The registered enrollment target is 1,297 participants, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (759% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01322490, a Phase 3 study of Prostate Cancer Metastatic, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,297 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
Primary Outcome
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- DRUG GM-CSF
- BIOLOGICAL PROSTVAC-V
- BIOLOGICAL PROSTVAC-F
- OTHER GM-CSF Placebo
Study Locations (20)
California
- Alta Bates Summit Medical Center - Berkeley
- Cedars-Sinai Medical Center - Los Angeles
- Prostate Oncology Specialists, Inc. - Marina del Rey
- Desert Hematology-Oncology - Rancho Mirage
- San Bernardino Urological Associates - San Bernardino
- San Diego Clinical Trials - San Diego
- Sharp Memorial Hospital - San Diego
- VA San Diego Healthcare System - San Diego
- Stanford Advanced Medical Center - Stanford
Florida
- South Florida Medical Research - Aventura
- Manatee Medical Research Institute, LLC - Bradenton
- Florida Urology Physicians - Fort Myers
- Lakeland Regional Cancer Center - Lakeland
- Pinellas Urology, Inc. - St. Petersburg
- James A Haley Veteran Affairs Medical Center - Tampa
Colorado
- University of Colorado - Aurora
- The Urology Center of Colorado - Denver
Alaska
- Alaska Clinical Research Center, Llc - Anchorage
Arizona
- Scottsdale Healthcare - Scottsdale
District of Columbia
- Washington Cancer Institute - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,297 participants |
| Start Date | 2011-11-28 |
| Est. Completion | 2017-12-15 |
| Phase | Phase 3 |
What the finished NCT01322490 record still lists
NCT01322490 is an interventional study that assigns participants to a tested intervention. Its 1,297 participants enrollment target places it among the larger protocols in the corpus, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (759% higher).
The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01322490 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01322490 about?
NCT01322490 is a clinical study titled "A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer". The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
What is the current status of trial NCT01322490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,297 participants. The study started on 2011-11-28. Estimated completion is 2017-12-15.
What conditions does trial NCT01322490 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic.
What interventions are being tested in trial NCT01322490?
The interventions under investigation include: Placebo (BIOLOGICAL), GM-CSF (DRUG), PROSTVAC-V (BIOLOGICAL), PROSTVAC-F (BIOLOGICAL), GM-CSF Placebo (OTHER).
Who is sponsoring clinical trial NCT01322490?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01322490 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01322490's enrollment target sits among peer trials
1,297 2nd of 17 the highest of 17 other Prostate Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer Metastatic 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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