Quality of Life in Men With High Risk Localized Prostate Cancer

NCT00877617 | Withdrawn

• 1 other identifier: 2006-0305
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

QOL Questionnaire

Behavioral: QOL Questionnaire

Interventions

QOL Questionnaire BEHAVIORAL

Mailed survey.

QOL Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Curtis A. Pettaway, MD, BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 8, 2009
• Study Start: May 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)