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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1297

Last updated 2019-09-04

Study results available
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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

  • Prostate Cancer Metastatic

Interventions

BIOLOGICAL

PROSTVAC-V

BIOLOGICAL

PROSTVAC-F

DRUG

GM-CSF

OTHER

GM-CSF Placebo

BIOLOGICAL

Placebo

PROSTVAC V/F Placebo

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • James L. Gulley, MD · National Cancer Institute (NCI)

  • Philip Kantoff, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-28
Primary Completion
2017-09-25
Completion
2017-12-15

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • Iceland
  • Israel
  • Netherlands
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322490 on ClinicalTrials.gov