Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT01322490 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322490
The ClinicalTrials.gov registry entry for NCT01322490 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,297 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01322490 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01322490?
This trial is sponsored by Bavarian Nordic, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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