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Asymptomatic or Minimally Symptomatic

Sipuleucel-T(Provenge) is a category 1 recommendation for patients with metastatic CRPC who are:

  • asymptomatic or minimally symptomatic
  • have good performance level (ECOG 0-1)
  • estimated life expectancy >6 months
  • no liver metastases.  


Sipuleucel-T (Provenge) is indicated for asymptomatic or minimally symptomatic metastatic CRPC.  This means it is appropriate to administer to patients who have a rising PSA, level castrate testosterone levels and documentation of metastatic disease (either at diagnosis or during treatment).


Sipuleucel-T has not been studied in patients with visceral metastases. Clinicians and patients should be aware that the usual markers of benefit (decline in PSA and improvement in bone or CT scans) are not usually seen, and therefore benefit to the individual patient cannot be ascertained using currently available testing. Treatment subsequent to sipuleucel-T treatment should proceed following published guidelines.


Sipuleucel-T is the first FDA approved immunotherapy for treatment of cancer that demonstrated a survival benefit for patients.  Approved in April 2010 this autologous cancer “vaccine” involves collection of immune cells(white blood cells), engineering them to fight prostate cancer, and then infusing them back into the patient.


Current NCCN guidelines indicate that Provenge should be administered prior to oral oncolytic therapy.


Benefits (

  • PROVENGE has been proven to help men live longer
    • Improved median survival by 4.1 months
    • Reduced risk of death by 22.5%
    • 38% of patients alive 3 years after treatment
  • Most side effects of PROVENGE are generally mild to moderate
    • Discontinuation rate only 1.5%
  • PROVENGE has a short treatment course
    • Therapy can be completed in about one month with only 6 appointments



What is the treatment process?

The treatment process take place in 3 steps.  

Step one is the leukapheresis process in which blood is removed from the patients arm, is run through a machine which separates the white blood cells(immune cells) from the rest of the blood and collects them and the remainder is returned to the patient.

Step two involves transporting the patients white blood cells to a facility where they are treated with a protein or marker that is specific to prostate cancer.  This protein induces an immune response to the patients cancer.

Step three the treated cells are reinfused into the patient to fight the cancer.

This process takes 2-3 days and is repeated for three total cycles approximately 2 weeks apart.

PROVENGE side effects

The most common side effects of PROVENGE are:

  • Chills            
  • Back Pain
  • Joint Ache
  • Fatigue.
  • Fevers.          
  • Nausea.        
  • Headache.    


Most of these”flu-like” symptoms are temporary and quite common with immunotherapies. They typically and within a day or two of the procedure.


Discontinuation rate is 1.5% due to side effects.


In clinical trials, some men experienced more serious side effects including chest pain, racing heartbeat, irregular heartbeat, dizziness, nausea, vomiting, stroke and thrombosis.  For additional Safety information please refer to or talk with your doctor.

There are no differences in safety in older versus younger patients. Since the treatment works in a different way it is worth considering how we view success. Only a minority of patients have a PSA drop or change in an imaging test. The FDA no longer bases it’s evaluation of HRPC treatment  on PSA values, but rather on the extension of life. This is what was found in the clinical trials with Provenge. Provenge extended survival in patients with HRPC significantly more than the control group and therefore prevent was approved.

There was a mean survival benefit of 4.1 months. Approximate 1/3 of men in the latest clinical trial were alive 3 years after treatment.

Provenge is indicated for asymptomatic or minimally symptomatic metastatic, castrate resistant prostate cancer. It has been used before or after the use of chemotherapy and second line hormone therapy. Studies have shown that patients on second line therapy and chemotherapy have improved efficacy of therapy if they have received Provenge previously.

Current NCCN guidelines indicate that Provenge should be administered prior to oral oncolytic therapy.

Hydrate yourself well prior to leukapheresis therapy.  Consuming enough water to be adequately hydrated is very important in order to not have delays in the leukapheresis process.

There is a temporary condition during leukapheresis that can occur which is known as paresthesia which is a sensation of tingling, prickling, or numbness of the skin around the mouth.  During leukapheresis a citrate compound is used to avoid blood from clotting while the white blood cells are harvested. Citrate can lower the serum Calcium level temporarily and cause the paresthesia.   Calcium carbonate 1000-1200 mg daily may help to decrease the risk of paresthesia.

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