NCT02772562

Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.

Detailed description

This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	PROSTVAC-V/F	0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1. 0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.

Timeline

• Start date: 2016-07-18
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2016-05-13
• Last updated: 2025-12-12
• Results posted: 2025-12-12

Locations

1 site across 1 country: United States