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Provenge: A Customized Treatment for Advanced-Stage Prostate Cancer Patients

What it is

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All interested patients should contact UCH at
(720) 848-4500 if they wish to be evaluated to find out if Provenge is an appropriate therapy for them.

Provenge is a type of "autologous cellular immunotherapy." The treatment, which is FDA-approved, is for men who have advanced prostate cancer that is not responding to hormonal therapies.

The University of Colorado Cancer Center (UCCC) participated in the original clinical trial for Provenge, and is being evaluated as a treatment site to provide the treatment.

How it works

Provenge therapy essentially trains the body's immune system to attack prostate cancer cells. The treatment involves removing the patient's own white blood cells through a process called apheresis, mixing the cells with a drug designed to target prostate cancer cells, and then re-infusing each patient's own treated blood. This process can be repeated twice, for a total of three treatments over approximately a month.

During clinical trials, this therapy significantly extended the lives of prostate cancer patients compared to placebo.

Important facts about Provenge

Dendreon, the company that manufactures Provenge, is expected to initially have a limited production capacity, although additional production capacity is being pursued.

Provenge therapy will be covered by Medicare; however, a price/reimbursement scale has not yet been established.

Patient criteria for Provenge treatment

Provenge therapy is for prostate cancer patients with metastatic prostate cancer, meaning that the cancer has spread beyond the prostate into lymph nodes, bone, etc. Additionally, eligible prostate cancer patients will have progression or growth of the prostate cancer despite the use of standard hormonal therapy.

Eligibility guidelines for Provenge therapy at UCH

  • Castrate resistant prostate cancer (not responding to hormonal therapy)
  • Bone scan or CT scan with evidence of prostate cancer spread to the lymph nodes or bones (but not the lungs, liver, or brain)
  • Little or no cancer-related pain (no need for narcotic pain medications for cancer pain)
  • Adequate organ function (liver, kidneys, bone marrow)
  • Other considerations, including history of autoimmune disease or significant heart or lung disease

These guidelines may be modified as our experience with Provenge increases.

Physician profiles

L. Michael Glodé, MD

Professor, Division of Medical Oncology

Research

 

As the first board-certified Medical Oncologist at the University of Colorado, joining the faculty after training at Dana-Farber Cancer Institute, Dr. Glode developed a long standing interest in GU oncology. He was Principal Investigator (PI) on the study leading to approval of leuprolide and is currently PI on the only national NCI-sponsored adjuvant treatment protocol for high-risk prostate cancer patients following surgery.

Dr. Glodé was a local principal investigator for one of the Provenge trials that evaluated the vaccine in hormone sensitive cancer. He has also participated in the evaluation of other vaccines including Prostvac, which is currently being considered for further study by a European firm.

As  members of the Division of Medical Oncology, Drs. Glodé and Flaig are involved with a large number of clinical trials both locally and nationally. Their practice involves urologic oncologists, radiation oncologists, pathologists and endocrinologists.

This practice is unique in the Rocky Mountain Region in bringing physicians with specific interests in prostate and other GU cancers together in one location. The group has published more than 600 articles in the field of GU cancer over the past decade and is nationally recognized for its expertise. It is one of the few centers in the world to have evaluated all of the advanced vaccines, Provenge, Prostvac, and G-VAX.

Thomas Flaig, MD

Assistant Professor, Division of Medical Oncology

 

Dr. Flaig is a medical oncologist dedicated to the care of prostate and urologic cancers.  He graduated from the University of Minnesota Medical School in 1999. After completing residency and serving as a chief resident at the Hennepin County Medical Center in Minneapolis, he moved to Colorado, where he completed his fellowship training at the University of Colorado.

He is board certified in both internal medicine and medical oncology. 

He is an active member of the American Society of Clinical Oncology, American Association of Cancer Research, University of Colorado Cancer Center, and the genitourinary oncology committee of the Southwest oncology group (SWOG).

Research

As a translational researcher, Dr. Flaig is focused on the development of new therapies to treat urologic cancers. He is currently the local Principal Investigator of several active clinical trials in prostate cancer.  These efforts include the evaluation of abiraterone acetate, MDV3100 and several other novel agents in prostate cancer. Dr. Flaig has also worked with silibinin, a natural product derived from milk thistle, for the treatment of prostate cancer. Both a silibinin dose-defining phase I trial and a biomarker study of silibinin in prostate cancer have been completed at the University of Colorado with these findings reported at national cancer meetings and in the medical literature.

 

Links

Clinical trials. Go to our clinical trials page. Once there, select "prostate cancer" from the drop-down menu.

Provenge web site

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