Regular monitoring and imaging is recommended by nationally recognized medical organizations to determine if the cancer has spread beyond the prostate.

PROVENGE is the first and only FDA-approved, personalized immunotherapy for advanced prostate cancer (metastatic castration-resistant prostate cancer, or mCRPC). PROVENGE is made from your own cells. By activating immune cells already in your body, PROVENGE personalizes the fight against your advanced prostate cancer. PROVENGE is clinically proven to extend life in certain men with advanced prostate cancer.

PROVENGE may be used before or after certain other therapies for advanced prostate cancer, or mCRPC. So even if you have already received treatment for advanced prostate cancer, you may benefit from PROVENGE.

Results from the IMPACT trial showed significant survival benefit in those men treated with PROVENGE compared with men who did not receive treatment with PROVENGE. Also, a post hoc analysis suggested that men who received PROVENGE with baseline PSA levels within the lowest 50% (ie, the median which was 22.1 ng/mL or less in this study) exhibited an overall survival that was 13 months longer than patients with baseline PSA levels above this median. In another post hoc analysis, regardless of whether their baseline PSA level in the lowest 25%, the 26-50%, the 51-75%, and above 75% of baseline PSA levels, men who received PROVENGE showed greater survival benefits than those who did not (ie, control) These post hoc analyses were exploratory, and individual results may vary.

The PROCEED Registry showed median overall survival of approximately 4 years in men who were treated with PROVENGE when PSA levels were less than or equal to 5.27 ng/mL at the start of treatment. The median is not the average but the middle of a set of numbers. The PROCEED Registry evaluated side effects and, secondarily, survival following treatment with PROVENGE in a medical-practice setting where all patients received PROVENGE and there was no untreated group. Patients may have received other cancer treatments as prescribed by their physician. The survival data was used to identify groups of patients who may live longer after treatment with PROVENGE. Exploratory analyses like these are limited in their ability to reliably predict treatment effects and individual results may vary.

The most common side effects of PROVENGE are generally mild to moderate and are well tolerated.

There are potential risks associated with PROVENGE:

• In controlled clinical trials, 71.2% of men treated with PROVENGE 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 treatment with PROVENGE include:

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

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 receiving 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.

As a personalized immunotherapy, PROVENGE works differently from other prostate cancer treatments , such as chemotherapy or hormone therapy.

• PROVENGE is personalized because it’s made from your own immune cells. It empowers your immune system’s ability to recognize and remember prostate cancer cells
• Similar to a vaccine, PROVENGE boosts your immune system’s ability to target and attack prostate cancer cells immediately, with effects that last over time

PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy. Unlike these treatments, PROVENGE may not lower your PSA level. The goal of PROVENGE treatment is not to lower PSA level, it is to extend life.

Measuring prostate-specific antigen (PSA) level and imaging (for example, bone scans) are two ways your doctor may watch for changes in your prostate cancer. These tests do not necessarily reflect how well a treatment works in advanced prostate cancer; they are part of standard monitoring for prostate cancer progression. In fact, PSA testing and imaging have led to early detection of metastases and to opportunities for treatment with the potential for improved outcomes. If you are receiving hormone therapy, talk to your doctor about regular monitoring to identify disease progression.

If you are a caregiver for someone with advanced prostate cancer, you understand the physical and emotional toll this disease takes on your loved one. Many men living with advanced prostate cancer don’t feel comfortable asking for help, but just knowing you are there can mean so much to him.