PROVENGE is a personalized immunotherapy made from your cells and for your prostate cancer.
National Comprehensive Cancer Network® (NCCN®) recommends sipuleucel-T (PROVENGE) as a first-line treatment option for certain men with advanced prostate cancer (mCRPC).
Your immune system is your body’s natural defense. PROVENGE is designed to work with your immune system to seek out and attack your prostate cancer cells. PROVENGE is made from your own cells. By activating immune cells already in your body, PROVENGE personalizes the fight against your prostate cancer.
PROVENGE is clinically proven to help extend life in certain men with advanced prostate cancer.
The pivotal study showed that more men treated with PROVENGE were alive than men not treated with PROVENGE.
PROVENGE prolonged life for men with both low and high prostate-specific antigen (PSA) levels. There may be greater survival benefits when men with advanced prostate cancer start PROVENGE while PSA levels are lower.b
aIndividual results may vary.bAnalysis was exploratory and individual results may vary.cPSA less than or equal to 22.1 ng/mL.
PROCEED is the largest real-world registry evaluating the use of PROVENGE® (sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). PROCEED enrolled nearly 2,000 men who received PROVENGE between 2011 and 2014 in an everyday treatment setting.
The PROCEED registry evaluated the expected safety and survival profile of PROVENGE® (sipuleucel-T) in a real-world treatment setting. Patients in PROCEED may have received other available therapies as prescribed by their doctor.
Men who received PROVENGE when their PSA was less than 5.27 ng/mL at the time of treatment, saw the greatest improvement to overall survival:d
PROCEED Registry – Baseline PSA and Median Survivale
PROCEED findings are consistent with a post-hoc analysis of the pivotal IMPACT Trialf, which suggests there may be greater survival improvement when men with advanced prostate cancer start PROVENGE while PSA levels are lower.
To learn more about treatment with PROVENGE, click HERE
dMedian overall survival in all quartiles of the PROCEED registry (PSA lower than 5.27 ng/mL, 47.7 months; PSA ≥5.27-≤15.08 ng/mL, 33.2 months; PSA >15.08-≤46 ng/mL, 27.2 months; PSA higher than 46 ng/mL, 18.4 months. Individual results may vary.eThe PROCEED registry evaluated the expected safety and survival profile of PROVENGE® (sipuleucel-T) in a real-world treatment setting. Patients in PROCEED may have received other available therapies as prescribed by their doctor. Individual results may vary.fMedian overall survival in all quartiles of the IMPACT trial (PSA lower than 22.1 ng/mL, 13 months; PSA 22-50 ng/mL, 7.1 months; PSA 51-134 ng/mL, 5.4 months; PSA higher than 134 ng/mL, 2.8 months). Individual results may vary.
There are potential risks associated with PROVENGE:
The most common side effects of PROVENGE prostate cancer treatment include:
PROVENGE infusion can cause serious reactions. Tell your doctor right away if:
These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor. Please see Important Safety Information.
Are you able to receive immunotherapy with PROVENGE?
Talk to your urologist or oncologist to find out if PROVENGE is right for you
When prostate cancer is diagnosed early, most men are treated with surgery or radiation. If their cancer returns, some men are treated with hormone therapy, also known as androgen deprivation therapy (ADT). This helps to shrink the cancer or make it grow more slowly. However, hormone therapy is not a cure, and additional treatment may be necessary.
PROVENGE is the first and only approved, personalized immunotherapy for mCRPC.
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. The NCCN recommends that sipuleucel-T (PROVENGE) be considered as a first-line treatment option in certain men with mCRPC.
In addition, while patients with varying levels of PSA may benefit from PROVENGE, a clinical study showed that patients with a lower PSA may benefit the most.a After your PROVENGE treatment, other options such as radiotherapy, hormone therapy, and chemotherapy may still be available to you.
If you have prostate cancer that has not yet spread to other parts of your body, but is no longer responding to hormone therapy, or if you have prostate cancer that has spread but is still responding to hormone therapy, ask your doctor why regular monitoring is important.
aAnalysis was exploratory and individual results may vary.
The NCCN recommends sipuleucel-T (PROVENGE) may be used before or after certain other therapies for certain men with advanced prostate cancer (mCRPC). Even if you already received treatment for advanced prostate cancer, you may benefit from PROVENGE.
Learn how 1 month of PROVENGE treatment may help men with advanced prostate cancer live longer.
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Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.3.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed June 21, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Access questions that can help you start the PROVENGE conversation with your urologist or oncologist.
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.
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.
Access this brochure to learn about PROVENGE and how it may help certain men with advanced prostate cancer (mCRPC) live longer.