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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. 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 is an investigational study. Up to 500 patients will take part in this study. All will be enrolled at MD Anderson, Spartanburg Regional Healthcare System, and/or MD Anderson Cancer Center Albuquerque. Researchers want to collect data and use this registry to learn about the long-term status of prostate cancer after these treatments.
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 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 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. 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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Kaseman Presbyterian Hospital
Albuquerque, New Mexico, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Start Date
January 26, 2009
Primary Completion Date
January 1, 2020
Completion Date
January 1, 2021
Last Updated
May 15, 2019
146
ACTUAL participants
Questionnaire
BEHAVIORAL
Lead Sponsor
M.D. Anderson Cancer Center
NCT04550494
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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