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Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy

2014-08-27 03:24:02 | BioPortfolio

Summary

The goal of this clinical research study is to create a registry (research database) of clinical data about patients who receive radiation therapy, with or without hormone therapy, to treat prostate cancer that has come back after surgical removal of the prostate. This treatment is standard and the actual treatment is not part of this protocol.

Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments.

This protocol includes collecting tissue for biomarker testing. You will be asked to allow leftover tissue from your prostate surgery to be used for this biomarker research. Biomarkers are chemical "markers" in the tissue that may be related to your response to treatment.

This protocol also includes a questionnaire study. You will be asked to complete questionnaires about your urinary, bowel, and sexual function.

Description

Screening:

Before you can join this study, the study doctor will review the results of your routine scans, previous cancer treatment and past medical history. This is a "screening" procedure to help the doctor find out if you are eligible to take part in this study.

Standard Treatment:

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 Prostate Specific Antigen (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.

Follow-Up Tests:

- 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 registry:

- 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 2 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 5 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.

Information Collection:

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 secure.

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 M. D. Anderson.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Prostate

Intervention

Questionnaire

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:02-0400

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