Quality of Life in Men With High Risk Localized Prostate Cancer

July 26, 2012 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

M.D.Anderson Cancer Center prostate cancer patients who have received neoadjuvant investigational therapies prior to radical prostatectomy for high risk clinically localized prostate cancer.

Description

Inclusion Criteria:

  • Prostate cancer patient who participated in one of the following neoadjuvant treatment trials:

    • DM96-140 - A Safety Study of TNP-470 Followed by Radical Prostatectomy for Patients with Locally Advanced Adenocarcinoma of the Prostate
    • DM97-095 - A Tolerance & Efficacy Study of Adenoviral Vector Expressing Wild-type P53 (AD-P53) Preoperative Administration Intraprostatically in Patients with Locally Advanced Prostate Cancer Followed by a Radical Prostatectomy
    • ID00-089 - A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed By Radical Retropubic Prostatectomy (RRP) In Select Patients With Locally Advanced Prostate Cancer
    • ID97-046 - Preoperative Chemotherapy Followed by Radical Prostatectomy for Patients with Locally Advanced Adenocarcinoma of the Prostate
    • ID99-061- A Randomized Trial of Preoperative Chemotherapy and Androgen Ablation Compared to Androgen Ablation Alone Followed by Radical Prostatectomy for Select Patients with Locally Advanced Adenocarcinoma of the Prostate The study will include those patients who completed preoperative therapy and radical prostatectomy.
  • Men over the age of 40 years.

Exclusion Criteria:

  • Patients that did not undergo both preoperative therapy and a radical prostatectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
QOL Questionnaire
Behavioral: QOL Questionnaire
Mailed survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Curtis A. Pettaway, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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