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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results < Back to Main
  • Posted: 02/03/2009

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Radiation Plus Hormone Therapy for Locally Advanced Prostate Cancer Improves Survival

Adapted from the NCI Cancer Bulletin.

A randomized clinical trial, published online December 15, 2008, in The Lancet, that tested hormone therapy (HT) alone versus HT plus radiation therapy (RT) for locally advanced prostate cancer adds to the body of evidence that adding RT to HT is more effective than HT alone for this group of patients (see the journal abstract).

Investigators from two European research groups, led by Dr. Anders Widmark of Umeå University in Sweden, assigned 875 men with locally advanced prostate cancer -- cancer that had invaded local tissue but had not spread to the lymph nodes or distant sites -- to receive either HT alone or HT plus standard 3D conformal RT. HT consisted of leuprorelin (known in the United States as leuprolide) given for three months and flutamide given until disease progression or death. Patients could switch to the drug bicalutamide if they experienced unacceptable side effects while taking flutamide.

After a median follow up of 7.6 years, 18 percent of the men in the HT group had died of prostate cancer compared to 8.5 percent of the men in the HT-plus-RT group. Ten-year mortality from prostate cancer was 23.9 percent for men in the HT group versus 11.9 percent in the HT-plus-RT group.

Follow-up visits revealed “a small but significant increase of moderate to severe late effects related to urinary and sexual function” in the HT-plus-RT group, stated the authors. However, patients did not report significant differences in their overall health and quality of life on surveys taken four years after treatment, with the exception of social function, which was decreased in the HT-plus-RT group.

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