Name of the Trial
Phase III Randomized Study of Radical Prostatectomy with Versus without Neoadjuvant Chemohormonal Therapy Comprising Docetaxel and Androgen-deprivation Therapy with Leuprolide Acetate or Goserelin in Patients with High-risk, Clinically Localized Prostate Cancer (CALGB-90203). See the protocol summary at http://www.cancer.gov/clinicaltrials/CALGB-90203.

Principal Investigators
Dr. James Eastham, Cancer and Leukemia Group B; Dr. Martin Sanda, Eastern Cooperative Oncology Group; Dr. Martin Gleave, NCIC-Clinical Trials Group

Why This Trial Is Important
Prostate cancer is classified as localized when there is no evidence it has spread (metastasized) to nearby tissue or lymph nodes. However, patients treated with surgery to remove the prostate and some surrounding tissue (radical prostatectomy) often experience recurrence of their disease due to the presence of undetectable (occult) cancer cells.

Doctors want to improve their ability to identify prostate cancer patients who fall into this high-risk group (i.e., men who have less than a 60 percent chance of remaining recurrence-free 5 years after treatment). One way to identify these patients takes into account factors such as tumor stage, higher levels of prostate-specific antigen (PSA), and other clinical signs, such as a higher Gleason score. However, said Dr. Eastham, "Once we identify them, there is no accepted treatment strategy for high-risk patients."

Some high-risk patients elect treatment before surgery (neoadjuvant therapy) in hopes of improving their long-term outcome. If their cancer's growth is dependent upon male hormones (androgens), anti-androgen therapy before surgery can reduce the extent of their disease. If their cancer is androgen-independent, systemic chemotherapy with a taxane drug has been shown to improve long-term survival.

In this trial, patients classified as high risk will be randomly assigned to undergo a course of neoadjuvant therapy or proceed directly to surgery. The neoadjuvant therapy will involve up to 18 weeks of docetaxel chemotherapy combined with hormone-depriving therapy using one of two drugs, either goserelin or leuprolide acetate, for 18-24 weeks. The idea, said Dr. Eastham, is to target two different populations of cancer cells that might separately be sensitive to each of these different approaches. "If such a strategy were effective, it could significantly change clinical practice."

For More Information
See the list of eligibility criteria and contact information at http://www.cancer.gov/clinicaltrials/CALGB-90203 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.