The Urology Center of Colorado Announces Clinical Trials to Study Potential of Denosumab to Prevent and Treat the Spread of Cancer to Bone in Men with Prostate Cancer

May 14, 2007

The Urology Center of Colorado announced today that it is currently enrolling patients with advanced prostate cancer in two phase 3 clinical trials to determine if an investigational therapy, denosumab, is effective in delaying bone metastases (cancer spreading to bone) and in reducing the complications of bone metastases such as fractures (broken bones) and radiation therapy in men with prostate cancer.  These clinical trials are being sponsored by Amgen Inc.

Prostate cancer is the most commonly diagnosed cancer in America among men with more than 218,000 new cases expected to be diagnosed in 2007.  In Colorado, 3,160 prostate cancer cases will be diagnosed this year. Approximately one in six men will be diagnosed with prostate cancer during their lifetime and all men with prostate cancer are at risk to develop bone metastases.

“It is important for patients with advanced prostate cancer to understand that their bone health may be at risk and that they should talk to their urologist or oncologist about treatment options or participation in clinical trials that may benefit them,” said Lawrence Karsh, M.D., research director and prinicpal investigator at the Denver trial site.  “We are excited to be enrolling patients in these denosumab trials to see if it works in slowing the spread of cancer to the bones or reducing the complications from bone metastases.”

Researchers are studying the potential of denosumab because it targets a protein called RANK Ligand, the primary mediator of the formation, function and survival of cells called osteoclasts.  Osteoclasts are cells which break down bone, and may be involved in the formation and spread of cancer in the bones.

A survey entitled “Cancer Clinical Trials Awareness and Attitudes in Cancer Survivors” that was conducted by the Coalition of Cancer Cooperative Groups and Northwestern University, polled nearly 2,000 U.S. cancer survivors, and found that as few as one in 10 cancer survivors report ever being made aware of trial opportunities during treatment.  For those patients who reported participating in clinical trials, the survey found that 92 percent of participants had a positive experience with their clinical trial.

For information about relevant clinical trials, go to www.rising-psa.com or call 1-800-536-8604 (hosted by Amgen Inc.). Patients accessing this Web site and toll free number will be provided with information about Amgen and other available prostate cancer clinical trials.

For more information about these clinical trials and others being conducted at The Urology Center of Colorado, please visit www.tucc.com or call 303.825.TUCC (8822).

About Bone Metastases
Bone metastases are cancer cells that separate from tumors, enter the bloodstream, and migrate to bone tissue where they settle and grow. The tumor cells and bone cells interact, which may lead to the disruption of normal bone metabolism and cause an increase in osteoclast (cells responsible for bone resorption) activity.  This interaction may stimulate tumor growth and bone destruction.

Bone metastases are one of the most frequent causes of pain in people with cancer and may lead to severe skeletal complications, such as fractures, spinal cord compression resulting in paralysis, need for surgery to bone, and need for radiation to bone for pain palliation.

Approximately 452,000 people in the United States suffer from cancer with metastases to the bone.  Certain cancers, like prostate cancer, are more likely to spread to the bone than others.

About The Urology Center of Colorado
The Urology Center of Colorado is the only fully-inclusive urology center in the Rocky Mountain region. From our state-of-the-art clinic to our full-service research department, TUCC provides patients with the latest advancements in urologic care. In addition to our specialties, TUCC physicians also treat general urologic conditions including benign prostatic hyperplasia (BPH), erectile dysfunction, genitourinary cancer, prostate disease, stone disease, urinary tract infections and urinary incontinence. All TUCC physicians are board certified by the American Board of Urology.