Empowering the immune system to detect & attack cancer cells
Provenge Immunotherapy
Our flagship product, PROVENGE® (sipuleucel-T), is a unique kind of cancer immunotherapy.
PROVENGE® (sipuleucel-T) reprograms the body’s own immune cells to detect and attack cancer cells.
In clinical settings, PROVENGE® (sipuleucel-T) has been proven to increase overall survival.
PROVENGE® (sipuleucel-T)
PROVENGE® (sipuleucel-T) has been available in the United States since 2010. It is the first and only FDA-approved immunotherapy for the treatment of advanced prostate cancer made from a patient’s own immune cells.
This groundbreaking treatment has been prescribed to nearly 40,000 men with advanced prostate cancer, helping many live longer.
For more information visit the links below:
Clinical Trials
In an effort to help even more patients with prostate cancer, we continue to investigate the potential of PROVENGE® (sipuleucel-T).
Active, Not Recruiting
P17-1 (PROVENT)
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.
P12-1 (PREDICT)
An observational study to evaluate characteristics predictive of a positive imaging study for metastatic disease in castrate-resistant prostate cancer (CRPC)
Complete
P11-3 (STAMP)
A randomized, open-label, Phase 2 Trial of sipuleucel-T with concurrent versus sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer (mCRPC).
P12-2 (STRIDE)
A randomized, open-label, Phase 2 trial examining combination therapy with sipuleucel-T and enzalutamide in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
P10-3 (PROCEED)
A registry of sipuleucel-T in men with advanced prostate cancer (PROCEED) to further evaluate safety and survival associated with sipuleucel-T
About The ProVent Study
The life-saving effects of immunotherapy treatment with sipuleucel-T have been proven in some men with advanced prostate cancer (also referred to as metastatic castrate-resistant prostate cancer or mCRPC), and research suggests that this cutting-edge therapy may also benefit men with lower risk prostate cancer who are on active surveillance (AS).
Nearly 175,000 men are diagnosed with prostate cancer every year.[i] Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS[ii]. The ProVent Study will evaluate the effectiveness of sipuleucel-T in reducing disease progression in men who are candidates for AS and looking for a proactive alternative to surgery or radiation.
AS has grown in popularity as a treatment option for men with lower risk prostate cancer and includes regular prostate-specific antigen (PSA) testing and tumor biopsies (every 1-2 years) to ensure the cancer is not growing or spreading. Choosing AS may allow some men to delay – or even avoid – surgery and radiation, which often result in life-altering side effects.[iii]
ProVent Study Details (NCT03686683)
- Phase 3 clinical trial evaluating the effectiveness of immunotherapy (sipuleucel-T) in reducing disease progression in men with lower risk prostate cancer on AS.
- The investigational ProVent study will enroll 450 men in the U.S. age 18 or older diagnosed with lower risk prostate cancer within 12 months of enrollment.
- Study participants will be randomized 2:1. This means that for every 2 participants that receive sipuleucel-T, 1 will receive the standard treatment protocol for AS.
- Sipuleucel-T uses a patient’s own cells trained to stimulate the body’s immune system to target and attack the prostate cancer cells.
For more information, please visit www.ClinicalTrials.gov or call (800) 772-3125. When prompted, please enter study code number: 170101 (do not hit the #, hash or number key). You may experience a brief silence until an available agent answers. In the event an agent is not readily available, you will be directed to a voicemail box.