Assessment of Quality of Life in Men With High Risk Localized Prostate Cancer Undergoing Neoadjuvant Investigational Therapy
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
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.
2 Years
No
Curtis A. Pettaway, MD, BS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2006-0305
NCT00877617
May 2006
February 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |