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The Right Time for PROVENGE Treatment

The Right Time for PROVENGE Treatment

You may benefit from PROVENGE if:

  • Your prostate cancer has progressed on androgen deprivation therapy (ADT)
  • Your testosterone level is less than or equal to 50 ng/dL
  • You have confirmed metastatic disease
  • You’re not taking narcotics for cancer-related pain

PROVENGE may be considered as your first-line treatment option if you have advanced prostate cancer.

You may benefit from PROVENGE, even if you don’t receive it as your first treatment option. PROVENGE has no contraindications and does not preclude the use of other available cancer treatments.

Nationally recognized medical organizations recommend treatment with PROVENGE even if you have received other treatments for advanced prostate cancer.

Know your Disease Status

Although men with varying levels of PSA may benefit from PROVENGE, IMPACT, the trial that led to FDA approval of PROVENGE, suggests that men with a lower PSA level may benefit the most.a After treatment with PROVENGE, other options, such as radiotherapy, hormone therapy, or chemotherapy may still be available to you.

If you have prostate cancer that is no longer responding to hormone therapy, it means your cancer may now be castration resistant. It is important to monitor your disease. Talk with your doctor about imaging to see if your disease has spread.

Alternatively, if you have prostate cancer that has spread but is still responding to hormone therapy, your cancer is considered hormone sensitive. It is important to talk with doctor about regular monitoring of your metastatic disease and your PSA. Regular monitoring can help capture progression as soon as it occurs.

a Analysis was exploratory and individual results may vary.

See results from IMPACT and PROCEED, two clinical studies of PROVENGE


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.


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 or call 1-800-FDA-1088.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at, 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 Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.