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Dendreon Initiates Large-Scale Clinical Trial to Investigate PROVENGE® (sipuleucel-T) in Men with Early-Stage Prostate Cancer on Active Surveillance

Truckee, CA (UroToday.com) -- ProVent Trial Aims to Halt Disease Progression, Reduce Need for Aggressive Intervention — Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, announced it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of PROVENGE® (sipuleucel-T) in reducing disease progression in men with prostate cancer on active surveillance (AS). PROVENGE was the first U.S. Food and Drug Administration (FDA)-approved immunotherapy made from a patient’s own immune cells and remains the only immunotherapy treatment for prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

“Dendreon led the way with PROVENGE, the first active cellular immunotherapy approved by the FDA,” said Jim Caggiano, chief executive officer of Dendreon. “We have already established that PROVENGE helps mCRPC patients live longer, and physicians have prescribed it to over 30,000 men. With this trial, Dendreon is taking another leadership position in the treatment of prostate cancer; if successful, it could again revolutionize the way the disease is treated.”
Nearly 165,000 men are diagnosed with prostate cancer every year.1 Approximately 30 to 40 percent opt for AS2 – which includes regular monitoring to ensure the cancer is not growing or spreading – instead of choosing more aggressive treatment options. AS can allow men to delay – or even avoid – surgery and radiation, which often result in life-altering side effects.3 To date, no anti-cancer drug has been proven to prevent the disease from progressing during AS.

“The large body of data collected on PROVENGE has proven it has a significant impact on increasing overall survival in men with mCRPC,” said Bruce A. Brown, M.D., senior vice president, medical, at Dendreon. “With the ProVent trial, our aim is to determine if PROVENGE can reduce prostate cancer disease progression in men on AS and potentially provide an alternative to choosing a treatment that can negatively impact quality of life.”3

The ProVent clinical trial will assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS, with a targeted enrollment of 450 participants. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization are eligible to enroll. Study enrollment is expected to begin in late 2018, with topline results expected in 2023.


References:
1. American Cancer Society. Key Statistics for Prostate Cancer. Key Statistics for Prostate Cancer | Prostate Cancer Facts. (n.d.). Retrieved from https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
2. Johns Hopkins Medicine. Men with Low-Risk Prostate Cancer in Active Surveillance Program Not Likely to Succumb to the Disease, Study Shows. Men with Low-Risk Prostate Cancer in Active Surveillance Program Not Likely to Succumb to the Disease, Study Shows - 08/31/2015. (n.d.). 
3. Chen RC, JAMA. (2017) 317(11):1141-1150. Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer. JAMA. 2017 Mar 21;317(11):1141-1150. doi: 10.1001/jama.2017.1652.
4. Klotz L., J Clin Oncol (2015) 33:272-277.