Quality of Life in Men With High Risk Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Assessment of Quality of Life in Men With High Risk Localized Prostate Cancer Undergoing Neoadjuvant Investigational Therapy

Status Withdrawn

Clinical Trial Summary

Primary Objectives:

1. 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).

2. 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.

Secondary Objectives:

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00877617
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: N/A
• Start date: May 2006
• Completion date: February 2010