Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy
If you are found to be eligible and you choose to take part, you will be enrolled in this
study. Study participants will be those who are receiving the standard radiation treatment
for prostate cancer, which has come back after surgical removal of the prostate. If your
PSA level is lower, you will receive radiation alone. If your PSA level is higher, you will
receive hormone therapy in addition to radiation. You will sign a separate consent form
that will describe these treatments and their risks in more detail. This study requires no
other treatment. The main purpose of this study is data gathering through the use of
questionnaires and tissue banking.
After your treatment (radiation with or without hormone therapy), you will receive routine
follow-up care. The results of the following routine tests will be entered into the
- After completing radiation, blood (about 1 tablespoon) will be drawn to check your PSA
levels every 3 months for the first 2 years, every 6 months for the next 3 years, and
every year from then on.
- If you receive hormone therapy, additional blood (about 1 tablespoon) will be drawn to
check the levels of testosterone hormone. These blood tests to check your testosterone
levels will be drawn at the same time as your PSA blood tests, until your testosterone
levels are in the normal range.
- Every 6 months for the first 2 years after completing radiation, you will have a
physical exam and a digital rectal exam. After that, the physical exam and digital
rectal exam will be repeated every year from then on.
While you are on study, on a long-term basis, researchers will collect information from your
medical records about the status of the disease. This information will be entered into the
registry. To identify you, the registry uses your medical record number instead of your
name or other identifying information. The registry is password-protected to keep the data
Length of Study Participation:
You will be on study for as long as you agree to keep taking part. If you go off study,
your data will no longer be entered into the registry.
This is an investigational study.
Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.
Observational Model: Cohort, Time Perspective: Retrospective
Registry (research database)
Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients.
Deborah A Kuban, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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