NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
January 11, 2005 • Volume 2 / Number 2 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Featured Clinical TrialFeatured Clinical Trial

Hormone Therapy Plus Chemotherapy For Prostate Cancer

Name of the Trial
Phase III Randomized Study of Androgen Blockade with Concurrent Chemotherapy Versus Delayed Chemotherapy in Patients with High-Risk Hormone-Naive Prostate Cancer (RTOG-P-0014). See the protocol summary at

Dr. Kenneth Pienta Principal Investigators
Dr. Kenneth Pienta, Radiation Therapy Oncology Group; Dr. Naomi Balzer-Haas, Eastern Cooperative Oncology Group; Dr. Arif Hussain, Cancer and Leukemia Group B; Dr. Gregory Swanson and Dr. Primo Lara, Southwest Oncology Group

Why Is This Trial Important?
Prostate cancer often needs male sex hormones (androgens) to grow. Doctors may treat hormone-sensitive (or hormone-naïve) prostate cancer by blocking the body's ability to make and use androgens in a procedure called androgen blockade. Most prostate cancers, however, eventually become androgen independent, and androgen blockade stops working. Doctors may then turn to various chemotherapy drugs to prolong patients' lives.

In this trial, researchers are investigating whether prostate cancer patients who receive chemotherapy at the start of androgen blockade live longer than patients who receive chemotherapy only after androgen blockade has stopped working. All of the patients, who are deemed to be at high risk of death from their disease, will receive androgen blockade. Half of the patients will receive chemotherapy concurrently, while the other half will receive chemotherapy once androgen blockade has failed.

Who Can Join This Trial?
Researchers seek to enroll 1,050 men aged 18 and over, diagnosed with adenocarcinoma of the prostate, whose cancer has recurred following local treatment (surgery or radiation) and who are at high risk of death as determined by a doubling of prostate-specific antigen within a period of 8 months. See the full list of eligibility criteria for this trial at

Where Is This Trial Taking Place?
Study sites in the United States and elsewhere are enrolling patients in this trial. See the list of study sites at

Contact Information
See the list of study contacts at or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.

An archive of "Featured Clinical Trial" columns is available at

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