Cryoablation And Radiation Effectiveness (CARE) for Bone Pain to Measure
Quality of Life, Complication Rates in Prospective, Randomized,
IRVINE, Calif., Nov. 27 /PRNewswire-FirstCall/ -- Endocare, Inc. (Nasdaq: ENDO), an innovative medical device company focused on the development of minimally invasive technologies used by urologists and interventional radiologists for tissue and tumor ablation, announced today that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) is supporting a multi-center study comparing the pain-reducing palliative effects of cryoablation and radiation therapy for patients who are experiencing focal pain from cancer that has metastasized to their bones. The prospective, randomized study, called Cryoablation And Radiation Effectiveness (CARE) for Bone Pain and led by interventional radiologist Matthew Callstrom, M.D., PhD, of Mayo Clinic, will evaluate the efficacy of percutaneous cryoablation compared to external beam radiation therapy (RT) as measured by pain relief, quality of life, analgesic use and complication rates. Dr. Callstrom is also leading another multi-center study on cryoablation of painful metastatic disease.
The trial will be open to patients nationwide through the NCI oncology group network and conducted by the North Central Cancer Treatment Group.
A total of 128 patients are expected to take part in the study. Percutaneous cryoablation is a minimally invasive procedure in which tumors are targeted with ultrasound, computed tomography or magnetic resonance imaging guidance and treated by freezing. This destroys or ablates the tumor. The Endocare Cryocare(R) System will be used to treat all patients in the cryoablation arm of the study. Endocare will also contribute to the funding of the study.
Endocare Chief Executive Officer, President and Chairman Craig T. Davenport noted that the bone is the most common site of metastases, or the spread of cancer, and that many patients do not get adequate pain relief from conventional treatments including chemotherapy, radiation or other drug therapies. There are estimates that more than 100,000 people worldwide suffer from painful bone metastases.
"This is a very important study for Endocare but also for the thousands of patients who are suffering from the spread of cancer to the bone and who have very few viable options to relieve the pain it causes while retaining an active lifestyle," Davenport added. "If the results of the study turn out the way that the early data demonstrate they should, we will have a significant new pain-relieving alternative for cancer patients."
Davenport also noted that Endocare already has clearance from the U.S. Food and Drug Administration to ablate tumors and tissue throughout the body, including this percutaneous cryoablation for palliation of painful metastatic lesions. It is hoped that the study will demonstrate that cryoablation is effective in bone cancer and this could be important to gain positive reimbursement decisions from both government and private payers, Davenport said.
About the NCCTG
The North Central Cancer Treatment Group (NCCTG) is a national clinical research group sponsored by the National Cancer Institute. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States, Canada and Mexico. The research and administrative base for NCCTG is located at Mayo Clinic in Rochester, Minn. NCCTG is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live. NCCTG specializes in researching methods of treating and preventing cancer, and in researching methods to alleviate the side effects of cancer and cancer treatments.
The National Cancer Institute (NCI), part of the National Institutes of Health in Bethesda, Maryland, coordinates the Nation's research program on cancer prevention, detection, diagnosis, treatment, rehabilitation, and control. NCI was established by Congress in 1937, and its programs were intensified in 1971 after passage of new legislation called the National Cancer Act. As a result of the 1971 legislation, the NCI has built a network that includes regional and community cancer centers, physicians who are cancer specialists, cooperative groups of clinical researchers, and volunteer and community outreach groups. NCI also has initiated cancer control programs to hasten the application of knowledge gained through cancer research.
Endocare, Inc. -- http://www.endocare.com -- is an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation. Endocare has initially concentrated on developing technologies for the treatment of prostate cancer and believes that its proprietary technologies have broad applications across a number of markets, including the ablation of tumors in the kidney, lung and liver and palliative intervention (treatment of pain associated with metastases).
Statements contained in this release that are not historical facts are
forward-looking statements that involve risks and uncertainties. Among the
important factors which could cause actual results to differ materially
from those in the forward-looking statements include, but are not limited
to, those discussed in "Risk Factors" in the Company's Forms 10-K, Forms
10-Q, and other filings with the Securities and Exchange Commission. Such
risk factors include, but are not limited to, uncertainty regarding the
ultimate results of the study described in this press release and
uncertainty regarding the ability to gain positive reimbursement decisions
from government and private payers. The actual results that the Company
achieves may differ materially from any forward-looking statements due to
such risks and uncertainties. The Company undertakes no obligation to
revise, or update publicly, any forward-looking statements for any reason.
Investor Contact: Media Contact: For Additional Information:
Matt Clawson Len Hall Craig T. Davenport, CEO
Allen & Caron, Inc. Allen & Caron, Inc. Michael R. Rodriguez, CFO
(949) 474-4300 (949) 474-4300 Endocare, Inc.
|SOURCE Endocare, Inc.|
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