Adverse events were evaluated in patients in the two groups. The study found that there were more adverse events in the radiation group (23.8%) vs the no-radiation group (11.9%). Adverse events included rectal complications, urethral stricture and total urinary incontinence.
"This is a major advance in our efforts to control prostate cancer," said Ian M. Thompson, MD, professor and chairman of urology at the University of Texas Health Science Center at San Antonio and the principal investigator of the study. "The study shows that a man with this high-risk disease who receives radiation after surgery cuts in half his risk of disease recurrence. It also significantly reduces his risk of receiving hormonal therapy, a treatment with a wide range of side effects and complications in later years due to cancer recurrence. Complications were twice as common after radiotherapy and this is clearly part of the risk-benefit discussion between the patient and physician.
"There are several common approaches at this time to these men after surgery who are found to have a higher risk of recurrence," said Thompson. "One is to give immediate radiation, a second is to follow the PSA until it becomes detectable and then give radiation, and a third approach at some centers is to wait until spread of the disease is confirmed and then start hormonal therapy. In this study, a third of men who received no initial treatment subsequently were given radiation, most commonly due to a rising PSA. In some respects, this study speaks then to the differences in two approaches: radiotherapy after surgery vs radiotherapy at disease recurrence."