Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00769223|
Recruitment Status : Recruiting
First Posted : October 9, 2008
Last Update Posted : April 8, 2020
RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.
|Condition or disease||Intervention/treatment|
|Prostate Cancer Radiation Toxicity||Other: medical chart review Other: questionnaire administration Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: radiation therapy|
- Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.
OUTLINE: This is a multicenter study.
Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.
Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.
|Study Type :||Observational|
|Estimated Enrollment :||3500 participants|
|Official Title:||Pre-Operative Gleason Score and PSA and Clinical Stage in Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer|
|Actual Study Start Date :||February 1, 1993|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||January 31, 2025|
- Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death [ Time Frame: Up to 30 years or until death ]The investigator will be analyzing the effect of baseline patient and clinical features such as age, Gleason score, PSA, clinical stage and percent positive biopsies on survival as well as quality of life parameters including potency, continence, and American Urological Association (AUA) symptoms scores
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): NCT00769223
|Contact: Mach Roach, MDemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Mack Roach, MD 877-827-3222 firstname.lastname@example.org|
|Principal Investigator:||Mack Roach, MD||University of California, San Francisco|