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NIH-funded study shows reduction in death for men with intermediate-grade prostate cancer;

results seen with use of short-term hormone therapy plus radiation therapy

Short-term hormone therapy given in combination with radiation therapy to men with early-stage prostate cancer increased their chances of living longer compared to treatment with radiation therapy alone, according to a clinical trial supported by the National Cancer Institute (NCI), part of the National Institutes of Health. Benefits of the combined treatment were limited mainly to patients with intermediate-risk disease and were not seen for men with low-risk prostate cancer, researchers say. The results appeared in the July 14, 2011, New England Journal of Medicine. The trial was conducted by the Radiation Therapy Oncology Group.

The study, the largest randomized trial of its kind, enrolled nearly 2,000 men with low-and intermediate-risk prostate cancer and followed their health status for more than nine years at 212 centers in the United States and Canada. All study participants had localized, or non-metastatic, prostate cancer and serum prostate-specific antigen (PSA) levels of less than 20 nanograms per milliliter. PSA levels of less than 20, along with normal blood tests and a normal bone scan, indicate that the cancer is low or intermediate risk. Patients were randomly assigned to treatment with radiation alone or radiation plus short-term androgen deprivation therapy (ADT) using drugs that drastically lowered their natural production of testosterone, a hormone which feeds prostate cancer growth.

In addition to investigating whether the participants lived longer on one therapy compared to another, the researchers also looked at whether deaths occurred due to prostate cancer or some other cause, whether the prostate cancer spread, and several other outcomes. Study results were further analyzed on the basis of whether patients had low-risk or intermediate-risk disease. Risk was assessed using several parameters, including Gleason score (the grade of the tumor assigned by a pathologist based on an analysis of tissue samples from a biopsy), PSA level, and clinical stage of disease. Intermediate-risk men had higher Gleason, PSA, and clinical stage values than low-risk men.

The researchers reported a statistically significant improvement in the overall survival after 10 years on the trial for participants who received the short-term ADT and radiation compared with those who received radiation therapy alone (62 percent vs. 57 percent overall survival). Radiation therapy plus short-term ADT was also associated with fewer prostate cancer-related deaths compared to radiation therapy-alone (8 percent vs. 4 percent for the entire study population).

“This study has important significance for clinical care,” says the lead author Christopher U. Jones, M.D., Radiological Associates of Sacramento, Calif. “We now have strong scientific evidence about which patients with early-stage prostate cancer benefit from short-term ADT. This is important both for improved clinical care and the utilization of health care resources.”

Prostate cancer rates are higher among black men than other racial/ethnic groups. Therefore, this trial recruited nearly 400 African-American men, allowing evaluation by racial subgroups. Similar benefits from short-term ADT were seen in white and African-American populations for 10-year overall survival, disease-specific mortality, and climbing PSA levels after initially lowered levels due to ADT. The strong minority representation in this study will permit additional in-depth analyses of the effects of these therapies in different populations in the future.

Among men with low-risk disease, short-term ADT produced little improvement in 10-year overall or disease-specific survival. It is possible that, for patients with low-risk disease, longer follow-up is required to reveal a benefit. However, given that short-term ADT has substantial quality of life consequences, including hot flashes and higher rates of erectile dysfunction, and the 10-year disease-specific mortality in the radiation-alone arm for men with low-risk disease was 1 percent, the researchers noted that these findings do not support adding short-term ADT for low-risk prostate cancer. Newer high-dose radiation treatments may also lessen the need for use of ADT in low-risk patients.

“This type of trial is the gold standard for proving one therapy, or combination of therapies, is more effective than another, and NCI is strongly committed to sponsoring and conducting even more of these types of trials in the future,” said Jeff Abrams, M.D. associate director of NCI’s Cancer Therapy Evaluation Program. “Enrolling enough patients in clinical trials is always a challenge, and we owe a great deal of gratitude to the men who participated in this trial because these results will bring benefits to many men facing prostate cancer.”

NCI leads the National Cancer Program and the NIH effort to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI Web site at www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Reference: Jones CU, Hunt, D, McGown DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut, MH, Husain, SM, Rotman M, Souhami L, Sandler, HM, and Shipley WU. Radiation and Short-Term Androgen Deprivation for Localized Prostate Cancer. NEJM. Vol. 365, pgs 107-118. July 14, 2011. doi/full/10.1056/NEJMoa1012348

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