For Release: January 15, 1999
Contact:
Michael J. Bernstein
(703) 648-8910, [email protected]
Cynthia Schell, (703) 648-8928, [email protected]
National Clinical Trial Evaluates the Benefit of Adding
Hormonal Therapy to Radiation After Prostate Surgery
The Radiation Therapy Oncology Group (RTOG) is now examining, by a randomized clinical trial, the effectiveness of adding Casodex,' a hormonal therapy agent, to radiation for prostate cancer patients with rising PSA (prostate specific antigen) following radical surgery. Such rises in the PSA indicate recurrence of the disease.
Casodex' (bicalutamide) is a new nonsteroidal anti-androgen. Although anti-androgens block the stimulation of male hormones on normal and cancerous prostate cells, they have been shown to be less likely to impair a patient's libido and potency than other hormonal therapies.
William U. Shipley, M.D., study chairman, said the clinical trial will "evaluate radiation therapy with or without high-dose Casodex' in prostate cancer patients who were treated with radical prostatectomy and in whom the cancer had spread microscopically outside the prostatic capsule and who subsequently had a rising PSA."
Dr. Shipley, chair of genitourinary oncology, Department of radiation Oncology at The Massachusetts General Hospital, Boston, MA, noted that salvage radiation alone for these patients has potentially cured 30-45 percent of them. This clinical protocol evaluates whether high-dose Casodex' will increase the cure rate by at least another 10-15 percent. This Phase III trial is a double-blinded, placebo-controlled study.
The high dose of Casodex,' while well tested for safety in more than 9,000 patients, not now available or approved as a standard therapy following radiation, Dr. Shipley said.
Earlier RTOG trials have studied the potential benefit of adjuvant hormonal therapy and the benefit of maximum androgen blockade as a new adjuvant hormonal therapy.
The results of these trials combining radiation and hormonal therapy compared to radiation therapy alone are very encouraging for increasing survival in some subsets of patients, according to Dr. Shipley, who is professor of radiation oncology at Harvard Medical School.
RTOG is a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide. It is a major clinical research component of the American College of Radiology. For further information about RTOG clinical trials, please call Nancy Smith at 215-574-3205.
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