Active Surveillance in Prostate Cancer: A Prospective Cohort Study
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. At the beginning of the study, at 6 months, at 12
months, and again every year from then on you will fill out a survey about your diet. This
food survey will take 30 to 40 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
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
This is an investigational study. About 1,000 patients will take part in this study. All
will be enrolled at MD Anderson.
Observational Model: Cohort, Time Perspective: Prospective
Disease Progression Rate of Asymptomatic Patients with Clinically Localized Prostate Cancer at 5 Years
Jeri Kim, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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