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Immunotherapy, also called biologic therapy, treats the whole body by attempting to activate a person’s immune system so that it will destroy any prostate cancer cells within the body. Instead of attacking cancer cells directly, immunotherapy helps your body 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 immunotherapies including vaccines, monoclonal antibodies and non-specific immunotherapy. Ask your doctor the following questions to learn more about immunotherapy treatment options for prostate cancer:

  • 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?
  • Will you be testing my tumor for MSI-H/dMMR?
  • 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 an 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 in clinical studies to help specific patients live longer.

Immunotherapy uses the patient’s own immune system to fight cancer. 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 the 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. This infusion process is repeated three times on a bi-monthly basis. 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.

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 (mCRPC), 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, will result in an even 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.


KEYTRUDA® (Pembrolizumab) is a drug that targets PD-1, a protein found on your T cells, which are your immune cells. KEYTRUDA works by blocking PD-1 on your T cells, which boosts the immune system’s response to the prostate cancer cells. 

Currently, KEYTRUDA is FDA-approved for prostate cancer patients whose cancer has progressed following treatment and whose prostate cancer has been shown by a lab test to be a microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer. KEYTRUDA is the first treatment approved by the FDA based on a biomarker and not on the tumor type.

How does a test for MSI-H or dMMR work?

MSI-H and MMR deficiency are identified by a biomarker test performed on a tissue sample from the prostate cancer biopsy.

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.


Content last updated: 6/15/21