Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00052481
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy.
PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
* Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
* Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
* Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.
OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).
Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.
PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to treatment failure Up to 10 years
- Secondary Outcome Measures
Name Time Method disease progression Up to 10 years
Trial Locations
- Locations (13)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fletcher Allen Health Care - Medical Center Campus
🇺🇸Burlington, Vermont, United States
Scroll for more (3 remaining)UCSF Comprehensive Cancer Center🇺🇸San Francisco, California, United States