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Immunotherapy, also called biologic therapy, is an exciting new field of study that is designed to boost the body’s immune system to fight cancer.It uses materials either made by the body or in a lab to improve, target or restore immune function. There are different types of immunotherapy including vaccines, monoclonal antibodies and non-specific immunotherapies. In prostate cancer, a treatment vaccine helps the body’s immune system fight cancer by training it to recognize and destroy cancer cells. Become informed:

  • Am I a candidate for immunotherapy?
  • How will this treatment affect my daily life?
  • Will I be able to work, exercise, and enjoy my life?
  • What immunotherapy clinical trials are available to me?

In the video below, medical oncologist Alicia Morgans, M.D., explains the basics of immunotherapy.


PROVENGE® (Sipuleucel-T) is a pioneering immunotherapy vaccine treatment that is used in men with advanced, metastatic hormone-resistant, asymptomatic prostate cancer. PROVENGE is a personalized immunotherapy that activates the immune system to help fight advanced prostate cancer and has been proven to help specific patients live longer.

Immunotherapy or biotherapy uses the patient’s own immune system to fight cancer when standard therapies have failed. The only FDA approved immunotherapy for prostate cancer is PROVENGE® (sipuleucel-T). PROVENGE fully activates immune cells to better identify prostate cancer cells as abnormal cells in the body. Approximately 95% of prostate cancer cells express an antigen called prostatic acid phosphates, or PAP. PROVENGE helps a man’s immune cells recognize cells that display PAP and attack those cells

The personalization process involves extracting the white blood cells (immune cells) and sending them to a Dendreon Corporation facility where they are activated to program T cells (that belong to a group of white blood cells known as lymphocytes) to destroy prostate cancer cells. The newly activated cells are returned and then infused into the individual three days later. Since the blood cells are donated by the patient, there is little chance of rejection. The most common side effects are flu-like symptoms that last about 24 hours.

This infusion process is repeated three times on a bi-monthly basis. PROVENGE® was approved by the FDA in April of 2010 after demonstrating safety and a survival benefit. Some of the men treated with PROVENGE during the clinical trial benefited more than others and are still alive five years later. The clinical trial included men with metastatic castrate-resistant prostate cancer, some of whom failed chemotherapy and therefore had exhausted other treatments options. The hope is that PROVENGE when used on men with a smaller tumor burden and in better health, would result in a much better survival benefit.

A several-year-long study (called PROCEED), with thousands of patients, evaluated the real-world use of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC, found that PROVENGE extends life in men with mCRPC and underscores its added effectiveness in African American men. These data were published online in Prostate Cancer and Prostatic Diseases (PCAN), a peer-reviewed Nature Research journal. The PROCEED data suggest that African American men exhibit survival differences compared with Caucasian men when treated with sipuleucel-T, especially at lower PSAs values. No other prostate cancer treatment has shown this level of added benefit in African American men with mCRPC. Sipuleucel-T is FDA-approved for men of any race with mCRPC.

The PROCEED Registry is the most recent study of PROVENGE. PROCEED was an observational study, in a medical practice setting, that evaluated the safety and survival of nearly 2,000 men who received PROVENGE. The patients were followed between 2011 and 2017. These men may have received other therapies, in addition to PROVENGE, as prescribed by their doctor. Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC) who had baseline prostate-specific antigen (PSA) levels ≤5.27 ng/mL demonstrated a median overall survival (OS) approaching 4 years with sipuleucel-T (PROVENGE) treatment, according to findings from the large real-world PROCEED trial.

Here’s what one patient said about the benefit of PROVENGE: “I was fortunate to be enrolled in a clinical trial for PROVENGE. When my activated immune cells were being infused into me in April 2010 the nurse ran into the room and informed me that PROVENGE  has just been approved by the FDA. I had my immune cells treated three times. Since my treatment, my PSA has stabilized despite the fact that my PSA had been going up while on ADT. Of all the treatments I have had for my prostate cancer, this one had the least side effects.” Please see Important Safety Information for additional details.

Other Promising Immunotherapies

Research continues to be done in developing new immunotherapy treatments for prostate cancer and expanding the indications for use of the current prostate cancer vaccine.  Two drugs currently being studied include PROSTVAC and Yervoy. To learn more about prostate cancer clinical trials and how to find a trial, visit the clinical trials section of our website.

PROSTVAC is a virus-based vaccine that has shown success in men with metastatic castrate-resistant prostate cancer. It would work similarly to Provenge but without the need to tailor the drug to each individual’s immune system.

Yervoy (ipilimumab) is a monoclonal antibody that is being studied in hormone-resistant prostate cancer. Unfortunately, the first large trial did not meet its goal, additional trials are ongoing in advanced prostate cancer.

Learn More

On May 27, 2015, the Cancer Research Institute presented a webinar on Emerging Concepts in Prostate Cancer Immunotherapy with cancer experts James Gulley, M.D., Ph.D. and Ravi Madan, M.D.

The experts discussed the basic concepts of therapies that are designed to stimulate the immune system in order to treat patients with prostate cancer, with a focus on immunotherapies that are FDA approved or in the late stages of clinical development for prostate cancer and potential future roles of cancer immunotherapy, including data that suggests that immune therapies can be combined with other types of therapies. They also address when to use and not to use immunotherapy and provide data about what to expect clinically from this type of treatment.

Watch the recorded webinar here.