Have You Considered PROVENGE?

PROVENGE is a personalized immunotherapy made from your cells and for your prostate cancer.


PROVENGE is the first and only FDA-approved, personalized (made from your own immune cells) immunotherapy for advanced prostate cancer (metastatic castrate-resistant prostate cancer [mCRPC]) in men who do not take prescription medicine for cancer-related pain.

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.

What to expect with PROVENGE

PROVENGE has been proven to help certain men with mCRPC (advanced prostate cancer) live longer.

The pivotal study showed that more men treated with PROVENGE were alive than men not treated with PROVENGE.

  • Men in the study had prostate cancer that had spread to other parts of their bodies despite hormone therapy and did not use prescription pain medicine to manage cancer-related pain
  • Median survival was 4.1 months longer for men treated with PROVENGE (25.8 months) than for men who were not (21.7 months)

Men taking PROVENGEa

25.8 months

Men not taking PROVENGE

21.7 months

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

  • Median survival was 13 months longer for men with a low PSAc treated with PROVENGE compared with men with a low PSA who did not receive treatment

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

  • Median survival of nearly 4 years after treatment with PROVENGE.
  • 44% of patients receiving PROVENGE did not receive any additional cancer treatments for at least one year. Of these men, 95% were treated with PROVENGE as first-line therapy as recommended by the National Comprehensive Cancer Network (NCCN).

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.

  • Findings suggest that patients with a PSA of less than 22.1 ng/mL at the time of treatment with PROVENGE lived more than a year longer than men who did not receive PROVENGE.

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.

Most common infusion side effects were limited to a couple of days

PROVENGE was generally well tolerated and most infusion-related side effects lasted 1 or 2 days.

There are potential risks associated with PROVENGE:

  • In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction
  • The most common events (≥ 20%) were chills, fever, and fatigue. In 95.1% of patients reporting acute infusion reactions, the reactions were mild or moderate. Fevers and chills generally resolved within 2 days (71.9% and 89%, respectively)
  • 1.5% of men discontinued their treatment with PROVENGE due to side effects

The most common side effects of PROVENGE prostate cancer treatment include:

  • Chills
  • Back pain
  • Joint ache
  • Fatigue
  • Nausea
  • Headache
  • Fever

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.
  • You 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.
  • You 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.
  • You get a fever over 100°F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection.

These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor. Please see Important Safety Information.

How you can harness the power of PROVENGE

PROVENGE is a treatment option for certain men with advanced prostate cancer, also known as metastatic castrate-resistant prostate cancer (mCRPC)

Are you able to receive immunotherapy with PROVENGE?

  • Your cancer has spread from the prostate to other places, such as your bones
  • You are not taking prescription pain medicine for cancer-related pain

Talk to your urologist or oncologist to find out if PROVENGE is right for you

Prostate cancer stages

What is prostate cancer?

  • Prostate cancer is the uncontrolled growth of abnormal cells in the prostate, which is a walnut-shaped gland that sits underneath the bladder. The main job of the prostate is to make seminal fluid—the liquid that allows sperm to swim
  • Prostate cancer is the most common cancer in men in the United States, after skin cancer

What is advanced prostate cancer?

  • Prostate cancer can be localized (only in the prostate) or advanced, which includes both regional (in the prostate and surrounding lymph nodes) and distant (metastasized or spread to other places in the body) disease

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.

  • Prostate cancer that no longer responds to hormone therapy is called castrate-resistant prostate cancer (CRPC)
  • Four out of 5 of these men will eventually have their cancer spread to other parts of the body. This is called metastatic castrate-resistant prostate cancer (mCRPC)
PROVENGE is the first and only approved, personalized immunotherapy for mCRPC.

You may benefit from PROVENGE first and early

PROVENGE may be considered as your first treatment option if you have advanced prostate cancer (also known as 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.

You may benefit from PROVENGE, even if you do not receive PROVENGE first

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.

Your PROVENGE experience

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.

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