Active Surveillance in Prostate Cancer

You have an early stage of prostate cancer that can be treated effectively with surgery or
radiation. If you choose to take part in this study, you will be agreeing to receive only
active surveillance. Active surveillance is an investigational way to manage low-stage small
volume prostate cancer. While on active surveillance, you will have no treatment for the
prostate cancer. However, you will have repeated Prostate Specific Antigen (PSA) tests,
physical exams, and other testing to detect when the cancer is becoming a greater risk which
may require you to begin treatment.

If you agree to participate in this study, you will not have standard therapy for prostate
cancer. Your diagnosis will be confirmed as being of low risk by tests at MD Anderson. Blood
will be drawn for PSA tests at the beginning of the study and every 6 months to monitor your
cancer.

You will have a biopsy of the prostate at the beginning of the study. Additional prostate
biopsies will be performed at your first repeat biopsy at Year 1, and when a doctor thinks it
is necessary.

You will have digital rectal examination every 6 months to see if your doctor can feel any
prostate nodules. You will have a transrectal ultrasonography every 12 months to see if your
doctor can detect any abnormalities in the prostate.

Additionally, you will fill out 7 surveys at the beginning of the study and again every 6
months about how you are coping with the disease and the quality of your life. Each survey
will take 5 to 10 minutes to complete.

While you are on study, if an exam or test results show that your disease is getting worse,
you will be given the opportunity to have treatment to remove the cancer. If you do choose to
receive treatment, you will be taken off study and continue to receive standard follow-up.

Long-Term Follow-Up:

Every 12 months, the study staff will review your medical record or you will be called or
e-mailed and asked how you are doing. If you are called, the call would only last a few
minutes.

This is an investigational study. About 1,000 patients will take part in this study. All will
be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients will have histologic proof of adenocarcinoma of the prostate within six
months of study entry.

2. Patients must agree to have repeat extended 11-core multisite biopsy (sextant
locations, midline, and 2 cores each from the left and right anterior horn) of the
prostate at study entry. A baseline prostate biopsy is not indicated if a repeat
biopsy following the extended biopsy scheme (at least 10 biopsy cores) was performed
at The University of Texas M. D. Anderson Cancer Center (MDACC) within 6 months of
study entry.

3. Patients who have clinically localized cancer defined by pathologic and PSA criteria
to be very low-risk/low-risk, patients with clinically localized cancer [not low-risk]
who have refused early intervention or chosen active surveillance as a management
option, and patients with clinically localized cancer who are precluded from local
therapy because of comorbidities.

4. Patients must agree to comply with the surveillance schedule.

5. Non-English speaking patients may participate in the study, but they will not be
required to complete the surveys.

6. Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study.

Exclusion Criteria:

1. Active noncutaneous malignancy at any site.

2. Prior radiation therapy for treatment of the primary tumor.

3. Planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation
therapy while on protocol.