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


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Curtis A. Pettaway, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0305

NCT ID:

NCT00877617

Start Date:

May 2006

Completion Date:

February 2010

Related Keywords:

  • Prostate Cancer
  • Quality of Life
  • QOL
  • Questionnaire
  • High Risk localized Prostate Cancer
  • HRLPC
  • Neoadjuvant Investigational Therapy
  • Radical Prostatectomy
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030