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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire | Prognostic factors and outcome for patients treated with radiation with curative intent for rising Prostate Specific Antigen (PSA) post-prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Information collection. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Registry (research database) | Analyze data annually beginning once 100 patients have 1 year of follow-up; Anticipate annual enrollment of 100 patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment | At the 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year follow-up visits. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having a rising prostate-specific antigen (PSA) level after prostate was surgically removed, meaning prostate cancer return.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah A Kuban, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaseman Presbyterian Hospital | Albuquerque | New Mexico | 87110 | United States | ||
| Spartanburg Regional Healthcare System |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Leftover tissue from prostate surgery to be used for biomarker research.
| Spartanburg |
| South Carolina |
| 29303 |
| United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |