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.
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 This Trial Is 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.
"This is a proof-of-principle study to demonstrate in a randomized, phase III trial that giving chemotherapy at the beginning of androgen blockade may improve survival in high-risk patients," said Dr. Pienta.
This trial is no longer accepting new patients. To find other prostate cancer clinical trials, search the NCI's database of clinical trials 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.