If you are a reader of the New Advanced Prostate Cancer Blog, you will know that Cancer ABCs has been a long-time proponent of using Provenge (Sipuleucel-T) as early as possible. Currently, Provenge is only approved by the Food and Drug Administration (FDA) for men with metastatic prostate cancer that has become castrate resistant (their prostate cancer no longer responds to hormone therapy).
Cancer ABC’s position on the early use of Provenge is based on data that clearly shows that the men who benefit the most are the men with the lowest disease burden when they start treatment. Following up on this fact, the company that manufactures Provenge, Dendreon, has initiated and is enrolling a new clinical trial (The ProVent Trial) for men on active surveillance (AS).
The ProVent Trial is a phase 3 trial for men on active surveillance. The trial is designed to evaluate the efficacy of Provenge for men who are still at one of the earliest stages of the disease, active surveillance. The trial’s goal is to assess the ability of Provenge to reduce the risk of disease progression in men on Active Surveillance.
The ProVent Trial is an important trial since 30% to 40% of men who are newly diagnosed opt to go on active surveillance. If Provenge at this early stage can delay the progression of cancer, many additional men might be able to either delay or avoid the need for any further treatment, as well as avoid the treatment’s attached side effects.
The ProVent trial is being conducted at approximately 50 sites in the United States. ProVent will enroll 450 men age 18 or older who have been diagnosed with lower risk prostate cancer within 12 months of their enrollment into the trial.
The trial is designed to be randomized 2:1. This means that for every two (2) men that receive Provenge, one (1) will receive the standard treatment protocol for active surveillance.
If you are interested in learning more about this trial go to www.ProVentStudy.com or call (800) 772-3125. When prompted, enter the study code number: 170101 (do
not hit the #, hash or number key).
A Patient webpage about the trial: http://proventstudy.com/