IRB Number:

1937-00

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as PSA and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.

Who is Eligible to Participate in the Study?

Men who are undergoing one of the following treatments for prostate cancer may be eligible:

• surgery
  
• external radiation therapy
  
• radioactive seed implantation
  
• hormonal therapy
  
• chemotherapy
  
• other treatments

The study is broken up into to four arms depending on the type of treatment:

High Risk for Recurrence or GPSM 10+ is for men who have had a radical retropubic prostatectomy done at Mayo and had a combination of two or more of the following; a high PSA, high Gleason Grade, positive seminal vesicles or positive surgical margins.

The radiation arms include two groups: Men treated with External Beam or Brachytherapy. Men who have undergone prostatectomy are not included in these groups.

The fourth group includes patients who have prostate cancer which is no longer responsive to hormonal therapy. These patients, also known as hormone refractory patients may be diagnosed with metastatic disease.

Additional Requirements / Information

If you receive treatment for prostate cancer, you will participate in routine follow-up. Routine follow-up will consist of blood draws of PSA at least every 6 ? 12 months for 5 years or more. These blood draws may be performed at the Mayo Clinic, or done near your home, at a medical facility with a kit that we will send you. Return visits to your physician will also be scheduled, but these may occur less frequently than the blood draws.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
If you wish to participate in our research study, please contact Urology Research Office at (507) 284-3369.

What is/are the Locations of this Clinical Trial?

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

Last updated: 10/22/2009