Overview

This trial is active, not recruiting.

Condition prostate cancer metastatic
Treatments prostvac-v, prostvac-f, gm-csf, gm-csf placebo, placebo
Phase phase 3
Sponsor Bavarian Nordic, Inc.
Start date December 2011
End date June 2017
Trial size 1298 participants
Trial identifier NCT01322490, BNIT-PRV-301

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF
prostvac-v
prostvac-f
gm-csf
(Experimental)
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF placebo
prostvac-v
prostvac-f
gm-csf placebo
(Placebo Comparator)
PROSTVAC V/F Placebo + GM-CSF Placebo
gm-csf placebo
placebo
PROSTVAC V/F Placebo

Primary Outcomes

Measure
Overall survival
time frame: Survival will be assessed over the life of the study

Secondary Outcomes

Measure
Proportion of event-free patients compared with placebo
time frame: Events will be measured at baseline and 6 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria

  • Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer. OR
  • PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria). Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).

Exclusion Criteria

    Additional Information

    Official title 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
    Principal investigator James L. Gulley, MD
    Description BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls. Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are: 1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF 2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo 3. (Arm P) Double placebo
    Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
    Information provided to ClinicalTrials.gov by Bavarian Nordic, Inc..