IRB Number:

06-005305

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to:
See if giving docetaxel chemotherapy, at the time a patient is starting hormonal therapy (treatments to lower testosterone) is more helpful than giving it only at the time the hormonal therapy is no longer working.

Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy (removal of testicles) used to lower a patient's testosterone. This puts prostate cancer into remission (cancer has completely or partially gone away) in most patients as testosterone can worsen the cancer. It is the standard treatment for prostate cancer. Normally chemotherapy is reserved for when a patient's cancer starts to grow again despite having a low testosterone level. In this study the patient will either get a chemo therapy drug docetaxel when they start hormonal therapy or when/if their cancer grows with a low testosterone level. If a patient is to have chemotherapy when starting hormones for the first time, they may get chemotherapy when/if their cancer grows back with a low testosterone level.

This protocol is suggesting that a patient's doctor use docetaxel (a type of chemotherapy) if the patient's disease gets worse, even if they had received docetaxel when they started hormone therapy. A patient's doctor may try another hormone treatment before starting them on docetaxel chemotherapy. The reason for this study is to see if getting docetaxel when a patient starts hormone therapy (or within 90 days of starting hormonal therapy) and again, if their disease gets worse, is better than getting docetaxel only at the time the patient's disease gets worse. This study will tell us which way is more effective in treating a patient's disease.

Who is Eligible to Participate in the Study?

- Diagnosed with prostate cancer which has spread to other parts of the body
- Patient's disease has spread beyond the pelvic and spinal bones with a total of four or more lesions or any spread of cancer to the liver or lung

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Before starting the study:
Patients will need to have the following exams, tests or procedures to find out if they can be in the study. If a patient has had some of them recently, they may not need to be done again.
- Physical Exam (medical history and vital signs)
- Blood tests
- Scans of the body (bone scan, chest scan, chest x-ray, abdomen/pelvis scan)

Patients will be put in one of two groups by chance (as in the flip of a coin). Which treatment group a patient will get assigned to will be determined by a process called randomization. This means that the treatment is assigned based on chance. A computerized selection process will be used to put a patient in one of the study groups. Neither the patient nor their doctor can pick the group the patient will be in. Patients will have an equal chance of being placed in either group. If they are put in Group A, the patient will get chemotherapy when starting hormonal therapy. If they are put in Group B, the patient will be treated with hormonal therapy alone.

During the study:
If the exams, tests and procedures show that the patient can be in the study, and they choose to take part, the patient will need the following tests and procedures. They are part of regular cancer care.

If a patient is to get chemotherapy right away, they will have the following done every three weeks, before the infusion:
- Physical exam (vital signs)
- Blood tests

If a patient is to get hormonal therapy alone, they will have the following tests every 12 weeks:
- Physical exam (vital signs)
- Blood test
When the patient is done taking chemotherapy, they will be followed every 12 weeks with a doctor visit to assess the status of their health and the cancer. Patients will get hormonal therapy continuously and if they are randomized to get chemotherapy when starting hormonal therapy, the patient will get docetaxel every three weeks for up to six doses in this study. This three week period of time is called a cycle. The cycle will be repeated six times.

How long will the Study run?

Patients will be in the study for about five months. They will continue to be followed for 10 years to look at the long-term effects of the study.

Sponsor(s): Eastern Cooperative Oncology Group (ECOG)

Study Activation/Registration Date: 03/05/2007

IRB Review and Approval Date: 01/25/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 568 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Patrick A. Burch, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 06/10/2008