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

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.

Timeline

Start

2011-11-28

Primary completion

2017-09-25

Completion

2017-12-15

Outcome

Missed primary endpoint

paper Neither active treatment had an effect on median OS PMID 30817251 ↗

registry analysis (superiority test); PROSTVAC-V/F-TRICOM + GM-CSF vs Placebo Control; p = 0.5885; Log Rank; NCT01322490 ↗

Publications

• Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GM-CSF	Protein / enzyme biologic	—	—
Subject	PROSTVAC-F	Vaccine	—	—
Subject	PROSTVAC-V	Vaccine	—	—

Indications