Clinical Outcomes Reported at ASTRO

Next Generation Prostate Ultrasound Studies
June 1, 2004
Abstract Accepted for Prestigious Meeting
July 13, 2005

Clinical Outcomes Reported at ASTRO

Sunday, October 17, 2004

Clinical Outcomes Reported at ASTRO Demonstrate Effectiveness of Palladium-103 Brachytherapy in Treatment of Aggressive Prostate Cancer

BUFORD, Ga., Oct 17, 2002- Theragenics Corporation(R) (NYSE: TGX) announced today the results of new studies confirming the effectiveness of TheraSeed(R), a Palladium-103 (Pd-103) brachytherapy product, in patients with aggressive cancer who previously were considered poor candidates for seeding. The findings, revealed in several presentations at the October 6-10, 2002, ASTRO (American Society of Therapeutic Radiology and Oncology) meeting in New Orleans, La., also reinforce the effectiveness of Pd-103 treatment for localized cancer.

“The scientific data presented at this year’s ASTRO meeting provides good news for prostate cancer patients,” said Christine Jacobs, Chairman, President and CEO of Theragenics Corporation(R). “Men diagnosed with low-, intermediate- or high-risk cancers can now look to TheraSeed(R), the primary product in these studies, to provide an exceptional cure rate, as well as a high quality of life with minimal side effects.

“Dr. Michael Dattoli’s data is particularly significant,” Jacobs said, “as it is the first 10-year study to quantify the overwhelming success of brachytherapy for aggressive, high-risk cancer. We now have data to support the effectiveness of brachytherapy with the TheraSeed(R) device for men with PSAs greater than 10.”

Commenting on his research, Dr. Dattoli said, “The data is extremely important since the vast majority of patients treated in this study would be considered categorically incurable using any other treatment method, namely radical prostatectomy, external beam radiation alone – with or without hormones, or external beam coupled with any other radioactive isotope. Yet 79 percent of these patients remained completely free of cancer without the use of hormonal therapy or chemotherapy.”

“We’re also pleased that several studies highlight the shorter duration of side effects of Pd-103 brachytherapy, resulting in enhanced quality of life when compared to I-125 therapy or external beam radiation techniques. Supported by this research, we will expand our efforts to treat all prostate cancer patients, regardless of their risk state,” Jacobs added.

More than 120,000 men with prostate cancer have been treated with TheraSeed(R) during the past 15 years. The results presented in the following studies confirm the effectiveness of Pd-103 brachytherapy in low- and intermediate-risk patients, as well as in high-risk patients.
“Brachytherapy Versus Brachytherapy Plus Beam Radiation for Prostate Cancer: Morbidity Outcomes from Two Prospective Randomized Trials,” presented by Dr. M. Ghaly and co-authored by K. Wallner, M.D.; G. Merrick, M.D.; L. True, M.D.; W. Cavanaugh, and W. Butler, Ph.D.

This study demonstrates that patients who received Pd-103 therapy with or without external beam radiation show a faster resolution of side effects than patients who receive I-125 therapy with or without external radiation. The morbidity scores returned to baseline levels within six months after brachytherapy in the Pd-103 patient group, while the I-125 group still had elevated levels 12 months after the procedure was performed.

“Benign Prostate-Specific Antigen (PSA) Spikes Following Permanent Prostate Brachytherapy,” presented by G.S. Merrick, M.D. and co-authored by R. L. Anderson, M.D.; W. M. Butler, Ph.D.; K. Wallner, M.D.; and R. W. Galbreath, M.D.

Data indicate patients receiving I-125 brachytherapy have twice as many benign PSA spikes as patients receiving Pd-103 therapy (33 percent versus 17 percent). The presentation describes the importance patients place on maintaining low PSA values during their recovery and the anxiety that results from any spikes in levels.

“Biochemical Outcomes Following Hormonal Therapy, Pd-103 Prostate Brachytherapy and 3D Conformal External Beam Irradiation in the Treatment of High Risk Prostate Cancer,” authored by R.G. Stock, M.D. and co-authored by M. Kollmeir, M.D., and N. N. Stome, M.D.

The study reports a five-year freedom from failure in 86 percent of patients receiving this therapy.
“Biochemical Failure Rates Following Combination External Beam Radiation and Palladium-103 Boost for Clinically Localized High Risk Prostate Cancer: 10 Year Results,” authored by Michael Dattoli, M.D.; co-authored by Richard Anthony Sorace, M.D.; Jennifer Cash, M.S., A.R.N.P., O.C.N.; and Kent Wallner, M.D.

This study found combined therapy with Pd-103 seeds is superior to prostatectomy, aggressive external beam radiation with or without hormones or combined radiation methods using other isotopes with or without hormones in this high-risk, difficult-to-cure patient population. Ten years post-therapy, this group experienced a 79 percent success rate.

About Brachytherapy

During brachytherapy a physician inserts a highly concentrated, yet confined dose of radioactive seeds in and around the prostate gland, destroying the cancer while minimizing the impact on surrounding healthy tissue. It is a one-time, minimally invasive procedure done on an outpatient basis, with most men returning to routine activity within three days. The seeds are rice-sized pellets, undetectable in the body by the patient and compatible with human tissue.

About Theragenics(TM)

Theragenics Corporation(R) is the manufacturer of TheraSeed(R), a rice-sized device used in the treatment of localized prostate cancer with a one-time, minimally invasive procedure. Theragenics(TM) is the world’s largest producer of Palladium-103 and also is involved in research and development utilizing Palladium-103 for the treatment of vascular disease, macular degeneration and other diseases, as well as research and development centered around other isotopes and their usage. The Company’s common stock is traded on the New York Stock Exchange under the symbol TGX. (Additional information is available on the company Web site: www.theragenics.com.)

TheraSeed(R) is a registered trademark of Theragenics Corporation(R).

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