Name of the Trial
Phase III Randomized Study of Androgen Suppression (AS) and Radiotherapy (RT) versus AS and RT followed by Docetaxel and Prednisone in Patients with Localized, High-Risk Prostate Cancer (RTOG-0521). See the protocol summary at http://cancer.gov/clinicaltrials/RTOG-0521.

Principal Investigators
Drs. Howard Sandler, Seth Rosenthal, Oliver Sartor, and Leonard Gomella, Radiation Therapy Oncology Group; Dr. Mark Garzotto, Southwest Oncology Group

Why This Trial Is Important
Although prostate cancer usually grows slowly, it remains the second leading cause of cancer death among American men. When the disease has not yet spread (metastasized) to nearby lymph nodes, patients are diagnosed with localized prostate cancer, but some individuals face a greater risk of disease progression than others, based on higher levels of prostate-specific antigen (PSA) and other clinical signs (higher Gleason score).

No chemotherapy drug has been approved to treat newly diagnosed high-risk patients, who often get radiation therapy to kill cancer cells in and near the prostate, as well as hormone (antiandrogen) therapy to block the growth and spread of cancer cells that survive radiation.

In this trial, after initial radiation and hormone therapy, men with localized, high-risk, androgen-responsive prostate cancer will be treated with the drugs docetaxel and prednisone. Use of these drugs has improved survival - and was approved by the FDA - for patients with metastatic prostate cancer that is no longer responsive to androgens (androgen-independent disease).

"We hope docetaxel's ability to disrupt microtubule biology will prove effective against micrometastatic prostate disease," said Dr. Sandler. Microtubules are an important part of the machinery cells use to divide and multiply. "The other three major cancers - breast, colon, and lung - all respond to adjuvant chemotherapy, and such a treatment would be widely used by prostate patients."

Who Can Join This Trial
Researchers will enroll 600 men aged 18 and over with prostate cancer determined to be at high-risk for recurrence. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/RTOG-0521.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/RTOG-0521, or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.