OHSU

Provenge Treatment Information

The U.S. Food and Drug Administration recently approved the use of the prostate cancer treatment Provenge, made by Dendreon Corp. of Seattle, WA. The treatment will be available at 50 clinical sites around the country, including OHSU Knight Cancer Institute. The OHSU Knight Cancer Institute has been actively engaged in clinical trials to test Provenge prior to regulatory approval. Tomasz Beer, M.D., a medical oncologist at OHSU Knight Cancer Institute who specializes in prostate cancer has led these efforts and has provided national leadership to the phase II trial which is evaluating Provenge in earlier stages of prostate cancer.  The OHSU Knight Cancer Institute is actively engaged in studies of other immunologic therapies for prostate cancer.

Frequently Asked Questions 

 

What exactly is Provenge and how is it made?

Provenge is a new autologous cellular immunotherapy drug (that means it is made from a patient’s own immune cells) designed to stimulate a patient’s own immune system to respond against the prostate cancer. Read more

Who is Provenge for and how is the drug given?

Provenge is intended for the treatment of men with prostate cancer that is resistant to standard hormone treatment, and who have minimal or no symptoms of the disease. One course of treatment involves three separate cell collections and three I.V. infusions.  Read more

How many patients will OHSU Knight Cancer Institute treat with Provenge?

Because of limited supply and eligibility requirements, OHSU Knight Cancer Institute and other sites will be limited initially to accepting only a small number of patients per month.  We will increase this as quickly as possible.
 

How do patients qualify to receive Provenge?

Patients must meet disease indications as outlined by the FDA. Patients need to be seen and evaluated in the OHSU Knight Cancer Institute’s prostate cancer clinic to be considered for treatment.
 

How soon will Provenge be available?

We expect that OHSU Knight Cancer Institute will have Provenge available on a very limited basis beginning in June, 2010.  Read more

Will public and private insurance cover the cost of Provenge treatment?

In general, Medicare and private insurers provide coverage for FDA-approved cancer treatments.  Read more

How effective is Provenge?

The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment. Read more

What about side effects?

For the most part, the trial patients treated with Provenge did not experience any different side effects from those side effects seen when a patient receives any blood product. The most common side effects were mild and included chills, fatigue, fever, back pain, nausea, joint ache and headache. Read more

What exactly is Provenge and how is it made?

Provenge is a new autologous cellular immunotherapy drug (that means it is made from a patient’s own immune cells) designed to stimulate a patient’s own immune system to respond against the prostate cancer. Each dose of Provenge is manufactured specifically for each patient – created from each patient’s immune cells. About 3 days before each scheduled infusion of Provenge, a patient’s immune cells will be collected at a collection center. For OHSU patients, that collection center is the American Red Cross in Vancouver, WA: 3114 E Fourth Plain Blvd., Vancouver, WA 98661. The cells will then be flown to a Dendreon manufacturing facility, the company that makes the immunotherapy. To enhance their response against the cancer, the immune cells will be exposed to a protein that is found in most prostate cancers and is linked to an immune-stimulating substance. After this process, the cell/protein mix, Provenge, is flown back to the patient’s hospital, where he will be treated intravenously.

Who is Provenge for and how is the drug given?

Provenge is intended for the treatment of men with prostate cancer that is resistant to standard hormone treatment, and who have minimal or no symptoms of the disease. One course of treatment involves three separate cell collections from the patients, called leukapheresis, approximately 2 weeks apart. This is followed each time by giving the patient an IV infusion of the processed cells about 3 days later. A full course of Provenge covers three separate treatments, each about two weeks apart. 

How many patients will OHSU Knight Cancer Institute treat with Provenge?

Because of limited supply and eligibility requirements, OHSU Knight Cancer Institute and other sites will be limited initially to accepting only a small number of patients per month.  We will increase this as quickly as possible.

How do patients qualify to receive Provenge?

Patients must meet disease indications as outlined by the FDA. Patients need to be seen and evaluated in the OHSU Knight Cancer Institute’s prostate cancer clinic to be considered for treatment.
 

How soon will Provenge be available?

We expect that OHSU Knight Cancer Institute will have Provenge available on a very limited basis beginning in June, 2010. Patients should contact our comprehensive prostate cancer clinic at 503 418-5129 if they believe that they may be a candidate for Provenge therapy. A nurse coordinator will talk with each patient to determine whether he is a candidate for Provenge or other unique treatments available only OHSU Knight Cancer Institute. An appointment will then be made for evaluation by one of the OHSU Knight Cancer institute’s Prostate Cancer Clinic doctors. Initially, current OHSU Knight Cancer Institute patients who live in the Pacific Northwest region will be given priority for the limited treatment slots available. Initially, current OHSU Knight Cancer Institute patients who live in the Pacific Northwest region will have priority for the limited treatment slots available.

Will public and private insurance cover the cost of Provenge treatment?

In general, Medicare and private insurers provide coverage for FDA-approved cancer treatments.  We therefore expect that this treatment will be covered by most insurance plans. However because this treatment is so new, it is unclear how quickly insurance companies provide coverage for Provenge. Further, patient co-pays can vary greatly between plans. Once authorization for Provenge is given by an insurance provider, qualifying patients will work with an OHSU Knight Cancer Institute managed care coordinator in navigating the insurance coverage process.

How effective is Provenge?

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival by 22%. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment. While clearly more progress is needed, this is only the second drug to have lengthened lives in this most advanced stage of prostate cancer.   
 

What about side effects?

For the most part, the trial patients treated with Provenge did not experience any different side effects from those side effects seen when a patient receives any blood product. The most common side effects were mild and included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one-quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular (involving blood vessels in the brain) events, including hemorrhagic (bleeding) and ischemic (relating to restriction of blood supply) strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group. Tell your doctor immediately if you get a fever over 100°, or redness at the infusion or collection sites; any could be a sign of infection. Tell your doctor immediately about any side effect that concerns you or does not go away.

Sources: FDA, Dendreon Corp., Dr. Tom Beer