Quality of Life in Men With High Risk Localized Prostate Cancer
- To describe patient quality of life (QOL) related to bladder, bowel, and sexual function, as well as mental and physical health, in patients who received neoadjuvant investigational therapies prior to radical prostatectomy (RP) for high risk clinically localized prostate cancer (HRCLPC).
- To identify medical and demographic variables that are related with quality of life, e.g., hormonal or non-hormonal neoadjuvant treatment, time since surgery, disease recurrence, subsequent treatment, age, ethnicity, and socioeconomic status.
1. To describe treatment satisfaction expressed by patients who have received neoadjuvant investigational therapies prior to radical prostatectomy for high risk clinically localized prostate cancer.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Assessment of Quality of Life in Men With High Risk Localized Prostate Cancer Undergoing Neoadjuvant Investigational Therapy|
- Quality of life (QOL) variables related to bladder, bowel, and sexual function, as well as mental and physical health, in patients who received neoadjuvant investigational therapies prior to radical prostatectomy (RP) for HRCLPC. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Behavioral: QOL Questionnaire
Regardless of the survival benefit that a proposed treatment affords a patient, if it results in a poor QOL, it may not be considered a reasonable option. To assess this critical issue, QOL surveys have been developed to determine the post-therapy impact of a given treatment.
In prostate cancer, one of the most widely used validated survey instruments is the Expanded Prostate Cancer Index Composite (EPIC) .8 It contains 4 primary domains that elicit details regarding urinary, bowel, sexual, and hormonal function. The EPIC questionnaire has been widely applied, although it has not been administered to patients undergoing neoadjuvant investigational therapies prior to radical prostatectomy for HRCLPC. Obtaining this information will be important for counseling patients considering similar trials in the future since it will reflect long-term outcomes for functional recovery and mental health—two key concerns of patients deciding whether to enter clinical trials. Furthermore, researchers will be able to stratify these outcomes based on the specific treatment arm to possibly determine how to optimize outcomes while reducing negative impacts of a given therapy.
This is a cross-sectional descriptive study of the QOL of prostatectomy patients who have received neoadjuvant treatment. Anticipated 131 patients will receive a brief survey by to complete and return by mail to M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877617
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Curtis A. Pettaway, MD, BS||UT MD Anderson Cancer Center|