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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 ³.

Principal Investigators

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

Dr. James Eastham Principal Investigator

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 (for example, 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 ³ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.

Glossary Terms

Describes the ability of tumor cells to grow in the absence of androgens (hormones that promote the development and maintenance of male sex characteristics). Many early prostate cancers require androgens for growth, but advanced prostate cancers are often androgen-independent.

A drug used together with other drugs to treat certain types of breast cancer, stomach cancer, prostate cancer, and certain types of head and neck cancer. It is also being studied in the treatment of other types of cancer. Docetaxel is a type of mitotic inhibitor. Also called Taxotere.

A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.

A drug that belongs to the family of drugs called gonadotropin-releasing hormone analogs. Goserelin is used to block hormone production in the ovaries or testicles.

A drug used to treat symptoms of advanced prostate cancer. It is also being studied in the treatment of other conditions and types of cancer. The active ingredient 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. Some brands of leuprolide are also used to treat early puberty in children and certain gynecologic conditions. Leuprolide acetate is a type of gonadotropin-releasing hormone analog. Also called Eligard, Lupron, and Viadur.

To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy.

A protein made by the prostate gland and found in the blood. Prostate-specific antigen blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland. Also called PSA.

Surgery to remove the entire prostate. The two types of radical prostatectomy are retropubic prostatectomy (surgery through an incision in the wall of the abdomen) and perineal prostatectomy (surgery through an incision between the scrotum and the anus).

Treatment with anticancer drugs that travel through the blood to cells all over the body.

A type of drug that blocks cell growth by stopping mitosis (cell division). Taxanes interfere with microtubules (cellular structures that help move chromosomes during mitosis). They are used to treat cancer. A taxane is a type of mitotic inhibitor and antimicrotubule agent.