What Is Provenge? Understanding This Prostate Cancer Vaccine
Key takeaways:
Provenge (sipuleucel-T) is an immunotherapy medication known as a cancer vaccine.
Men with certain types of advanced prostate cancer may use Provenge.
Provenge is made by using your own cells and can have some serious side effects.
Prostate cancer is the second most common cancer in males. Although there are many ways to treat prostate cancer, immunotherapy is a type of treatment that’s growing in popularity. It boosts your own immune system so it can better recognize and destroy cancer cells.
Prostate cancer can sometimes hide from the immune system and continue to grow without being noticed. Certain types of immunotherapy can be used to treat prostate cancer, including Provenge (sipuleucel-T). Provenge is an autologous cellular immunotherapy, meaning it’s created using your own cells.
The FDA approved Provenge in 2010, and it’s used to treat prostate cancer that no longer responds to hormone therapy. This is also known as metastatic castration-resistant prostate cancer, or mCRPC. It’s not recommended for everyone. But it can be useful in certain types of advanced stage (metastatic) prostate cancer.
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Here we’ll discuss Provenge — how it works, how effective it is, and side effects it can cause.
What is Provenge?
Provenge is the first personalized immunotherapy that has been shown in studies to extend life for some people with mCRPC. Provenge is a type of cellular immunotherapy that’s known as a cancer vaccine.
Provenge is used for the treatment of asymptomatic or mildly symptomatic mCRPC. You may be eligible to receive Provenge if:
Your cancer got worse while taking hormonal medications.
You have metastatic cancer.
You are experiencing little to no symptoms from your cancer.
Your cancer hasn’t spread to your liver
Your prognosis is 12 months or longer
Why is it called a cancer vaccine?
Traditional vaccines improve your body’s natural ability to protect itself against bacteria and viruses. You may be most familiar with vaccines as a preventive therapy — like the flu vaccine you may get for preventing the seasonal flu every year.
However, Provenge is a cancer treatment vaccine. It’s different from other vaccines. It treats people who have already developed prostate cancer. Provenge is a cellular therapy designed to improve the response to cancer. It doesn’t prevent prostate cancer.
Cancer vaccines can teach your body to protect itself against its own abnormal cells, like cancer cells. Your body can then seek out and destroy those cancer cells. We’ll discuss how Provenge works below.
How does it differ from traditional vaccines?
As mentioned, Provenge isn’t a traditional vaccine or immunization. It’s made using your own blood.
Each dose is unique and is manufactured specifically for you. The process of making Provenge involves collecting your own immune cells — like white blood cells — in a procedure called leukapheresis. The collected immune cells are then sent to a lab. At the lab, they’re exposed to a protein from prostate cancer cells called prostatic acid phosphatase (PAP). They’re also exposed to a cytokine (a protein) called GM-CSF that activates the immune system. These cells are then placed back into your body.
This process trains your immune cells to be able to better fight prostate cancer when they’re placed back into your body. These trained cells are what Provenge is made of.
After your immune cells are collected and your Provenge dose is made, you receive Provenge as an intravenous (IV) infusion. You’ll receive Provenge in 3 cycles, usually about once every 2 weeks. You’ll get each infusion about 3 days after the leukapheresis procedure.
How does Provenge work?
The exact way that Provenge works isn’t fully known.
But we do know that Provenge stimulates your own immune system to seek out and destroy prostate cancer cells. It does this by causing an immune response against PAP, a protein found on most prostate cancer cells. In other words, Provenge trains your immune cells to find and get rid of cancer cells.
How effective is Provenge?
Provenge doesn’t cure prostate cancer. But it has been shown to lengthen life in some people with mCRPC who have little to no symptoms.
One study found that Provenge extended survival in people with mCRPC by about 4 months. For people who received Provenge, there was a 22% lower risk of death compared with people who didn’t receive Provenge.
Another study showed that people who received Provenge with a lower starting prostate-specific antigen (PSA) level lived more than 1 year longer than people who didn’t receive Provenge. PSA is a protein the prostate makes that is sometimes higher in people with prostate cancer. This suggests that men with earlier-stage cancer and lower starting PSA levels may have the most benefit from treatment with Provenge.
What are common Provenge side effects?
Common side effects that occur in more than 30% of people taking Provenge include:
Infusion-related reactions (nausea, difficulty breathing, etc.)
Chills
Fatigue
Fever
Back pain
Less common side effects that occur in fewer than 30% of people taking Provenge include:
Headache
Low red blood cell counts
Dizziness
Muscle pain
Flu-like symptoms
Does it have any serious risks or side effects?
Provenge can have some potentially serious side effects that are important to be aware of. These can include:
Infusion reactions: Although these can be common, as mentioned above, they can also be intense. Infusion reactions that happen within 1 day of infusion can include nausea, fever, rigor or chills, and difficulty breathing. To prevent infusion reactions, your healthcare provider may give you medications — such as acetaminophen (Tylenol) and diphenhydramine (Benadryl) — before a Provenge infusion.
Blood clotting: Severe blood clots, including a deep venous thrombosis (DVT) and pulmonary embolism (PE), can occur. Provenge should be used with caution in people with risk factors for blood clots.
Blood vessel problems: Strokes and heart attacks have been reported. These risks may be higher for men with certain medical conditions, such as heart disease.
Does insurance usually cover Provenge?
Treatment with Provenge can be expensive, and cost can vary depending on your insurance coverage. Medicare and most private insurance plans cover Provenge. Dendreon, the manufacturer of Provenge, also has a patient assistance program that may be able to help with treatment costs.
The bottom line
Provenge is a unique type of therapy for the treatment of later-stage prostate cancer that has stopped responding to hormone therapy. It’s a type of personalized cancer vaccine therapy that is different from chemotherapy. Provenge isn’t recommended for everyone with prostate cancer. To determine if you’re a candidate to receive Provenge, discuss your treatment options with a cancer specialist.
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References
Anassi, E., et al. (2011). Sipuleucel-T (provenge) injection: The first immunotherapy agent (vaccine) for hormone-refractory prostate cancer. Pharmacy and Therapeutics.
Dendreon Pharmaceuticals LLC. (2020). Provenge [package insert].
Hu, R., et al. (2016). What is the role of sipuleucel-T in the treatment of patients with advanced prostate cancer? An update on the evidence. Therapeutic Advances in Urology.
Kantoff, P.W., et al. (2010). Sipuleucel-T immunotherapy for castration-resistant prostate cancer. New England Journal of Medicine.
Madan, R.A., et al. (2020). Putting the pieces together: Completing the mechanism of action jigsaw for sipuleucel-T. JNCI: Journal of the National Cancer Institute.
Schellhammer P.F., et al. (2013). Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the immunotherapy for prostate adenocarcinoma treatment (IMPACT) trial. Urology.
