Advanced Prostate Cancer – PROVENGE (sipuleucel-T)

man in a wheelchair speaking with a healthcare worker

What is prostate cancer?

Prostate cancer is the uncontrolled growth of abnormal cells in the prostate. In the United States, prostate cancer is the most common cancer in men.

Prostate cancer can be described in a number of ways, depending on the stage and where the cancer is located. Prostate cancer can be localized (only in the prostate), or metastatic (spread to other areas of the body outside of the prostate).

When prostate cancer is diagnosed while it is still localized or has limited metastases, most men are treated with surgery or radiation. If the cancer returns, men may often be treated with androgen deprivation therapy (ADT). The purpose of ADT is to lower testosterone which will hopefully shrink the cancer or slow its growth.

Playful senior couple having fun in the park

What is advanced prostate cancer? What is mCRPC?

Prostate cancer is described as advanced when it has progressed despite treatment to lower testosterone. When the cancer no longer responds to treatment like this, it can also be described as castration-resistant prostate cancer (CRPC). When CRPC has spread to other parts of the body, it’s described as metastatic CRPC (mCRPC). Metastatic prostate cancer can be found in the bone, lymph nodes, or soft tissues.

Advanced prostate cancer may require advanced treatment options.

What is PSA?

Prostate-specific antigen (PSA) is a protein made by the prostate. In healthy men, some PSA is found in the blood. If PSA levels in the blood are higher than normal, it may signal a problem in the prostate. Routine testing of PSA levels helps your doctor know when to order imaging to check for disease progression.

The Role of Imaging in Advanced Prostate Cancer

Imaging can help determine whether prostate cancer has spread (metastasized). When prostate cancer metastasizes to other areas of the body, it generally spreads to bones, lymph nodes, or soft tissue. There are several types of imaging that can help detect when prostate cancer has begun to spread beyond the prostate.

Common Types of Imaging for Advanced Prostate Cancer

Prostate-Specific Membrane Antigen (PSMA) Targeted Positron Emission Tomography (PET) Imaging

PSMA PET scan is a type of imaging test used to detect advanced prostate cancer. PSMA is a protein that is found on the surface of many prostate cancer cells. During the test, a small amount of radiolabeled PSMA ligands are injected into your bloodstream. This substance attaches itself to PSMA and emits a signal that can be detected by a special camera. This helps doctors locate and visualize areas where prostate cancer may have spread, such as lymph nodes or other organs.

Technitium Bone Scan

A technetium bone scan is a type of imaging test used to check for advanced prostate cancer that may have spread to the bones. During the scan, a small amount of a radioactive substance called technetium is injected into your bloodstream. This substance is attracted to areas of increased bone activity, such as where cancer may be present and a special camera takes pictures of your bones. Technetium bone scans are often used to determine the extent of prostate cancer spread to the bones and to monitor the response to treatments like PROVENGE.

Magnetic Resonance Imaging (MRI)

MRI provides detailed images of the prostate gland, surrounding tissues, and potential tumor involvement. It is particularly useful in assessing the local extent of the tumor.

Computed Tomography (CT) Scans

CT scans provide detailed cross-sectional images of the body, allowing for the detection of metastases in the lymph nodes and distant organs. In advanced prostate cancer, CT scans are used to evaluate the extent of disease spread and guide treatment decisions.

PSMA PET Imaging Agents

Currently (as of Aug.2023) there are 4 US FDA approved PSMA targeted PET imaging agents (LOCAMETZ, PYLARIFY, ILLUCCIX, and POSLUMA). All 4 radioactive diagnostic agents are similarly indicated for PET imaging of PSMA positive lesions in men with prostate cancer with suspected metastasis for initial definitive therapy, or suspected recurrence based on elevated prostate-specific antigen (PSA) level.

Treatments for Advanced Prostate Cancer

Men with advanced prostate cancer have a variety of treatment options. Your treatment choice depends on many factors, including the stage of your cancer and your overall health. Here are common treatment options.

Personalized immunotherapy for advanced prostate cancer

Activates immune cells to target and attack prostate cancer cells immediately, with effects that last over time.

Learn More

Hormone therapy

Blocks or slows the production or action of male hormones (androgens), which may fuel prostate cancer progression.

PARP inhibitors

PARP Inhibitors prevent DNA repair in cancer cells, resulting in cancer cell death.

Chemotherapy

A drug treatment that uses powerful chemicals with the intent to kill abnormally growing cells in your body.

Radiopharmaceuticals

Therapies that emit high-energy radiation to kill cancer cells and shrink tumors.

Androgen Receptor Signaling Inhibitors

Targeted therapies that work by blocking the androgen receptor or inhibiting androgen production. These medications help to suppress the growth and spread of cancer cells and can provide clinical benefits for patients with mCRPC. These are different from the hormonal therapy that you may continue to receive as determined by your physician.

Senior man on his mountain bike outdoors

Where can I find support?

For community support and more, download this list. You’ll find information for men with prostate cancer and resources for caregivers.

DOWNLOAD SUPPORT RESOURCES

INDICATION

PROVENGE^® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.

IMPORTANT SAFETY INFORMATION

Before receiving PROVENGE^®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.

Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.

The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.

PROVENGE is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, returned, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.

PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:

Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
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, shortness of breath, chest pain that worsens or deep breathing
Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites

Tell your doctor about any side effect(s) that concerns you or does not go away. For more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at drugsafety@dendreon.com, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.

To report a product complaint, email our Quality department at CQAcomplaints@dendreon.com. Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.

PRV.0017.USA.23

What is Advanced Prostate Cancer?