Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 500
- Locations
- 13
- Primary Endpoint
- time to treatment failure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
time to treatment failure
Time Frame: Up to 10 years
Secondary Outcomes
- disease progression(Up to 10 years)