# 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** · PHASE3 · COMPLETED · sponsor: **Bavarian Nordic** · enrollment: 1297 (actual)

## Conditions studied

- Prostate Cancer Metastatic

## Interventions

- **BIOLOGICAL:** PROSTVAC-V
- **BIOLOGICAL:** PROSTVAC-F
- **DRUG:** GM-CSF
- **OTHER:** GM-CSF Placebo
- **BIOLOGICAL:** Placebo

## Key facts

- **NCT ID:** NCT01322490
- **Lead sponsor:** Bavarian Nordic
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-11-28
- **Primary completion:** 2017-09-25
- **Final completion:** 2017-12-15
- **Target enrollment:** 1297 (ACTUAL)
- **Last updated:** 2019-09-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01322490

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01322490, "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". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01322490. Licensed CC0.

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