Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Prostate Cancer Home Page 2 NCI's gateway for information about prostate cancer.

Adapted from the NCI Cancer Bulletin, vol. 6/no. 1, January 13, 2009 (see the current issue ³).

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 ⁴).

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.

Glossary Terms

An anticancer drug that belongs to the family of drugs called antiandrogens.

An anticancer drug that is a type of antiandrogen.

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormonal therapy, and hormone treatment.

Side effects of cancer treatment that appear months or years after treatment has ended. Late effects include physical and mental problems and second cancers.

The active ingredient in a drug used to treat symptoms of advanced prostate cancer. It is also used to treat early puberty in children and certain gynecologic conditions. It is being studied in the treatment of other conditions and types of cancer. Leuprolide blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. It is a type of gonadotropin-releasing hormone analog.

Cancer that has spread from where it started to nearby tissue or lymph nodes.

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

A statistics term. The middle value in a set of measurements.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant.