Prostate Cancer Clinical Trial
Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate within the past 120 days
Stage II disease (T1c-T2a, N0, M0)
Concurrent enrollment on ACOSOG-Z0070
Not yet randomized to an intervention arm (radical prostatectomy or brachytherapy)
Willing and able to complete heath-related quality of life questionnaires
PATIENT CHARACTERISTICS:
Age
75 and under
PRIOR CONCURRENT THERAPY:
Endocrine therapy
More than 6 months since prior hormonal therapy for prostate cancer
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There are 13 Locations for this study
San Francisco California, 94143, United States
Washington District of Columbia, 20307, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28233, United States
Cleveland Ohio, 44195, United States
Burlington Vermont, 05401, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98431, United States
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