Last updated on August 2019

Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer


Brief description of study

The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to subjects followed on active surveillance as standard of care.

Detailed Study Description

The ProVent Study is designed to look at subjects who recieve sipuleucel-T compared to control subjects followed on AS. The study will enroll subjects being followed by AS and initially diagnosed within 12 months prior to Screening with either ISUP Grade Group 1 or 2 adenocarcinoma of the prostate.

The Screening Phase will begin at the completion of the informed consent process and continues until randomization. After Screening assessments are completed, eligible subjects will be randomized 2:1 to the sipuleucel-T arm or the control arm. Subjects randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label.

Subjects will undergotheir first leukapheresis within 60 days of randomization.

Subjects randomized to the control arm will be followed on AS. The Active Phase will begin at randomization and continues through completion of the end of Active Phase study visit (within 30 days of Biopsy 2). Once a subject from either the sipuleucel-T or control arms completes the end of Active Phase visit, they will enter the Follow-up Phase and complete Follow-up Phase visits every 6 months starting from their last Active Phase visit. The Follow-up Phase visits end when the last subject enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor.

Clinical Study Identifier: NCT03686683

Find a site near you

Start Over

City of Hope

Los Angeles, CA United States
  Connect »

John Wayne Cancer Institute

Santa Monica, CA United States
  Connect »

Skyline Urology

Torrance, CA United States
  Connect »

Urological Associates

Colorado Springs, CO United States
  Connect »

Advanced Urology Institute

Daytona Beach, FL United States
  Connect »

Rush University

Chicago, IL United States
  Connect »

Research by Design

Chicago, IL United States
  Connect »

Gottlieb Memorial Hospital

Glenview, IL United States
  Connect »

Comprehensive Urologic Care

Lake Barrington, IL United States
  Connect »

First Urology

Jeffersonville, IN United States
  Connect »

Iowa Clinical Research Corp.

West Des Moines, IA United States
  Connect »

Kansas City Urology Care, PA

Overland Park, KS United States
  Connect »

Tulane University

New Orleans, LA United States
  Connect »

Regional Urology, LLC

Shreveport, LA United States
  Connect »

Chesapeake Urology

Towson, MD United States
  Connect »

Urology Center of Englewood

Englewood, NJ United States
  Connect »

Delaware Valley Urology

Mount Laurel, NJ United States
  Connect »

Mount Sinai Health System

New York, NY United States
  Connect »

Aventiv Research - Colombus

Gahanna, OH United States
  Connect »

Oregon Urology Institute Research

Springfield, OR United States
  Connect »

Lancaster Urology

Lancaster, PA United States
  Connect »

Omega Medical Research

Warwick, RI United States
  Connect »

Carolina Urologic Research Center

Myrtle Beach, SC United States
  Connect »

The Conrad Pearson Clinic

Germantown, TN United States
  Connect »

The West Clinic

Germantown, TN United States
  Connect »

Urology Associates

Nashville, TN United States
  Connect »

Vanderbilt University

Nashville, TN United States
  Connect »

Urology San Antonio

San Antonio, TX United States
  Connect »

Virginia Urology

Richmond, VA United States
  Connect »

Urology of Virginia

Virginia Beach, VA United States
  Connect »

Cook County Health

Chicago, IL United States
  Connect »