Trials / Completed
CompletedNCT00052481
Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- Male
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | quality-of-life assessment |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2004-04-01
- Completion
- 2004-04-01
- First posted
- 2003-01-27
- Last updated
- 2016-07-06
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00052481. Inclusion in this directory is not an endorsement.