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Featured Clinical Trials

Cancer Studies Highlighted in the NCI Cancer Bulletin
  • Posted: 01/11/2005

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 1.

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.

Dr. Kenneth Pienta
Dr. Kenneth Pienta
Principal Investigator

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.

Contact Information

This trial is no longer accepting new patients. To find other prostate cancer clinical trials, search the NCI's database of clinical trials 2 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.

Related Pages



Glossary Terms

androgen-independent (AN-droh-jen...)
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.
phase III trial (fayz … TRY-ul)
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
randomized clinical trial (RAN-duh-mized KLIH-nih-kul TRY-ul)
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

Table of Links

1http://cancer.gov/clinicaltrials/RTOG-P-0014
2http://www.cancer.gov/clinicaltrials/search
3http://www.cancer.gov/cancertopics/types/prostate