New guidelines for drug studies for relapsed prostate cancer patients

NEW YORK, February 1, 2004 -- An abnormal or rising prostate specific antigen (PSA) blood test is often the first indication that a man may have prostate cancer. Even after diagnosis, the test continues to play a role in monitoring disease progression and assessing treatment outcomes. However, after a man has received curative therapy, there is uncertainty about what the PSA measurement means since the relationship of tumor mass and PSA value is less established at this time.

In an effort to resolve some of the treatment issues for the approximately 50,000 prostate cancer patients who will relapse each year, a national working group was organized by investigators from Memorial Sloan-Kettering Cancer Center, the National Cancer Institute, and the Prostate Cancer Foundation. The group has developed guidelines to define which patients should participate in a clinical trial and what compounds are appropriate for these studies. They recommend limiting treatment to patients who are at expected risk for developing metastatic disease. In addition, the group recommends that the only drugs that should continue to be evaluated in trials are ones that have demonstrated sufficient clinical activity as measured by a stabilized or declining PSA for a sufficient number of patients in a specified time. The Working Group's recommendations are published in the February 1, 2004 issue of The Journal of Clinical Oncology.

"We have not had good clinical models to help us predict whether the prostate cancer patient with a rising PSA after a radical prostatectomy or radiation therapy should be treated or observed," explained Dr. Howard Scher, Chief of the Genitourinary Service at Memorial Sloan-Kettering and first author of the study. "These guidelines will help standardize patient selection for a clinical trial, allowing us to tell a patient that a particular therapy is worth pursuing and what it will do for him in relation to his disease."

The working g

Contact: Joanne Nicholas
Memorial Sloan-Kettering Cancer Center

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