Prostate Cancer - Brachytherapy with Palladium-103 Better Than or Equal to Prostatectomy

Main Category: Cancer / Oncology
Article Date: 08 Mar 2005 - 0:00 PST

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Twelve-Year Research Proves Superior Efficacy of "Seed Therapy" for High- and Intermediate-Risk Prostate Cancer Patients -

A new peer-reviewed study demonstrates that cure rates achieved with brachytherapy using palladium-103 are better than or equal to traditional surgery for treating prostate cancer. The twelve-year study proves the superior efficacy of brachytherapy, or "seed therapy," for treatment of high- and intermediate-risk prostate cancer patients. The study is published in the Vol. 4, Issue 1 edition of the journal Brachytherapy and is now available online at sciencedirect.com/science/journal/15384721.

Key findings of the study reveal that high-risk prostate cancer patients treated with brachytherapy using palladium-103 experienced greater success than patients treated with prostatectomy. In fact, high-risk patients treated with seeding showed an 88% cure rate vs. a 43% cure rate obtained with surgery at 12 years. Similarly, the results for intermediate-risk patients were also impressive, with 12-year data reflecting a success rate of 89% with seed therapy vs. a 58% success rate with surgery. In addition, low-risk patients demonstrated comparable results with those treated with seeds experiencing a 99% success rate vs. a 97% success rate with surgery at 10 years. *

The study, "Palladium-103 Brachytherapy Versus Radical Prostatectomy in Patients with Clinically Localized Prostate Cancer: A 12-Year Experience From A Single Group Practice," was conducted by Jerrold Sharkey, M.D., Clinical Research Director of the Urology Health Center and Advanced Research Institute in New Port Richey (Greater Tampa area), FL, and Clinical Assistant Professor of Urology at the University of South Florida.

This study retrospectively reviewed data on 1,707 prostate cancer patients, treated from 1992 to 2004, at the Urology Health Center. All patients were diagnosed with localized cancer that had not extended outside of the prostate gland. Of the 1,707 study participants, 1,380 - or more than 80% - were treated with seed therapy; the others were treated with surgery.

All brachytherapy patients in the study were treated exclusively with the palladium-103 device TheraSeed®, manufactured by Theragenics Corporation®. Independent clinical studies demonstrate that the palladium composition of the TheraSeed® device acts faster, and results in significantly fewer complications, than iodine-based seeds.

"This new clinical study, once again, proves the efficacy of brachytherapy and further reinforces the long-term success rates of our TheraSeed® (palladium-103) implants," stated Ms. M. Christine Jacobs, Chairman, CEO and President of Theragenics™. "Dr. Sharkey's findings also confirm that treatment with the TheraSeed® device can offer patients a greater chance for a complete life regardless of risk factor."

"This twelve-year study demonstrates that brachytherapy should be offered without bias to all men with early organ-confined (stage T1 and T2) prostate cancer," said Dr. Sharkey. "It is, of course, important that the seed implants be performed with meticulous attention to technique by an experienced team of radiation oncology and urology specialists."

There is a growing trend of treating prostate cancer with brachytherapy. A 2003 membership study of urologists' practice patterns conducted by the Gallup Organization found that more urologists are performing seed therapy for prostate cancer. According to the study, seed therapy has increased from 16% in 1997 to 56% in 2003.

Brachytherapy is a form of radiation therapy that fights prostate cancer with rice-sized radioactive seeds implanted inside the body. A minimally invasive outpatient procedure, it is associated with a lower risk of quality of life implications, such as incontinence and impotence.

Dr. Sharkey's research results reflect outcomes generated by his group practice of six urologists (Drs. Raymond Behar, Stanley Chovnick, Ramon Perez, Juan Otheguy and Richard Rabinowitz), as well as radiation therapy colleague Dr. Zucel Solc and radiation physicist Dr. William Huff. Dr. Sharkey has authored numerous peer-reviewed articles published in Urology, Journal of Endourology, and Current Urology Reports.

The American Brachytherapy Society publishes Brachytherapy, an international and multidisciplinary journal that provides original peer-reviewed articles and selected reviews about the techniques and clinical applications of interstitial radiation, endovascular radiation, endovascular brachytherapy and systemic brachytherapy in the management of cancer, and cardiac and other diseases.

Theragenics Corporation® is committed to being a leading provider of brachytherapy treatment devices for prostate cancer and other degenerative disease states. The Company is the manufacturer and marketer of the palladium-103 device TheraSeed® and I-Seed, an iodine-125 based device. Both devices are used in the treatment of localized prostate cancer in one-time, minimally invasive procedures. Theragenics™ is the world's largest producer of palladium-103 and is involved in research and development utilizing palladium-103 and other isotopes for the treatment of a wide variety of diseases, including vascular disease and macular degeneration. For additional information on the Company, call Theragenics'™ Investor Relations Department at (800) 998-8479. The Company's common stock is traded on the New York Stock Exchange under the symbol TGX. Additional information can be found on the Company website: www.theragenics.com and on http://www.theraseed.com.

This release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, the accuracy of which is necessarily subject to risks and uncertainties, including, without limitation statements regarding physician acceptance of brachytherapy with palladium-103. Actual results may be affected by, among other things, the results of future clinical studies related to the treatment of prostate cancer, the potential for new or improved treatments for prostate cancer, other positive or negative developments regarding treatments for prostate cancer going forward, and other factors set forth from time to time in the Company's Securities and Exchange Commission filings.

All forward looking statements and cautionary statements included in this document are made as of the date hereby based on information available to the Company as of the date hereof, and the Company assumes no obligation to update any forward looking statement or cautionary statement.

* Prostate cancer patients in the high- and intermediate-risk categories had a prostate specific antigen (PSA) of greater than 10 and a Gleason score greater than or equal to 7. Low-risk patients were defined as having a PSA of less than or equal to 10, and a Gleason score of less than 7.

CONTACT:
Theragenics™ Investor Relations:
James A. MacLennan or Lisa Rassel,
800-998-8479 or 770-271-0233

or

Media inquiries:
Goodman Media International, 212-576-2700;
Heather Ross at hross@goodmanmedia.com or
Sakura Komiyama at skomiyama@goodmanmedia.com