Clinical trial NCT00877617: Quality of Life in Men With High Risk Localized Prostate Cancer
Official title: Assessment of Quality of Life in Men With High Risk Localized Prostate Cancer Undergoing Neoadjuvant Investigational Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Quality of Life
QOL
Questionnaire
High Risk localized Prostate Cancer
HRLPC
Neoadjuvant Investigational Therapy
Radical Prostatectomy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Curtis A. Pettaway, MD, BS
role: PRINCIPAL_INVESTIGATOR
References: