Empowering the immune system to detect and attack cancer cells

Our flagship product, PROVENGE, is a unique kind of cancer immunotherapy.

Watch this video to learn how it works.

PROVENGE reprograms the body’s own immune cells to detect and attack cancer cells, with little impact to healthy tissue or cells.

Additionally, PROVENGE may enable the immune system to fight prostate cancer cells as they change. This is because cancer cells that have been destroyed release identifying information into the bloodstream, which the immune system is trained to recognize and attack, should prostate cancer cells reappear.

In both clinical and real-world settings, PROVENGE has been proven to increase overall survival.

PROVENGE^® (sipuleucel-T)

PROVENGE 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 more than 30,000 men with advanced prostate cancer, helping many live longer.

For more information, please visit PROVENGE.com US healthcare professionals may visit PROVENGEHCP.com

Scientific Publications

Dendreon aims to stay at the forefront of development, manufacturing, and commercialization of immunotherapies that harness the power of the body’s immune system to help extend patients’ lives.

Real‐World Outcomes of Sipuleucel‐T Treatment in PROCEED, a Prospective Registry of Men With Metastatic Castration‐Resistant Prostate Cancer
Higano CS, Armstrong AJ, Sartor AO, et al.

Role of antigen spread and distinctive characteristics of immunotherapy in cancer treatment
Gulley JL, Madan RA, Pachynski R, et al.

Sipuleucel-T immunotherapy for castration-resistant prostate cancer
Kantoff PW, Higano CS, Shore ND, et al.

Clinical Trials

In an effort to help even more patients with prostate cancer, we continue to investigate the potential of PROVENGE (sipuleucel-T). For more information, please visit www.clinicaltrials.gov.

Active, 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.
To learn more, visit ClinincalTrials.gov.

Active, Not Recruiting

P12-1 (PREDICT)

An observational study to evaluate characteristics predictive of a positive imaging study for metastatic disease in castrate-resistant prostate cancer (CRPC)
To learn more, visit ClinincalTrials.gov.

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)
To learn more, visit ClinincalTrials.gov.

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).
To learn more, visit ClinincalTrials.gov.

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
To learn more, visit ClinincalTrials.gov.

ProVent Info

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]. A new 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)

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Phase 3 clinical trial evaluating the effectiveness of immunotherapy (sipuleucel-T) in reducing disease progression in men with lower risk prostate cancer on AS.

people

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.

threepeople

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.

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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.

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important safety information

INDICATION

PROVENGE^® (sipuleucel-T) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.

IMPORTANT SAFETY INFORMATION

Before getting PROVENGE, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke
Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements
PROVENGE is made from your own immune cells, collected approximately 3 days before each scheduled infusion of PROVENGE. The collection is called "leukapheresis" (pronounced loo-kuh-fuh-REE-sis). You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. You will then be monitored for at least 30 minutes. Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments
The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment
PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
- Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems
- Develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
- Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing
- Get a fever over 100?, or redness or pain at the infusion or collections sites. Any of these may be signs of infection
Tell your doctor about any side effect that concerns you or does not go away. For more information, talk with your doctor

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information.

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