Active Surveillance in Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00490763|
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : April 4, 2022
The goal of this clinical research study is to find out if men who have a type of prostate cancer that has been classified as "low risk" can safely not be treated for the disease. Doctors want to know if patients with "low risk" cancer can avoid or postpone therapy and the related side effects and still live as long as patients who immediately receive therapy.
This is an investigational study. There are no medications used in this trial.
About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Behavioral: Survey|
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.
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 follow-up.
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 minutes.
This is an investigational study. About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Observational|
|Actual Enrollment :||1139 participants|
|Official Title:||Active Surveillance in Prostate Cancer: A Prospective Cohort Study|
|Actual Study Start Date :||February 13, 2006|
|Actual Primary Completion Date :||September 6, 2021|
|Actual Study Completion Date :||September 6, 2021|
Patients with low-risk prostate cancer who choose to undergo active surveillance.
7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life.
Other Name: Questionnaire
- Time to Disease Progression of Asymptomatic Patients with Clinically Localized Prostate Cancer [ Time Frame: 5 years ]Primary end point of the study is time to disease progression, where progression is defined by pathologic criteria and/or an increase in tPSA value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490763
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christopher Logothetis, MD||M.D. Anderson Cancer Center|