Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality of life questionnaire<br>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 as part of ACOSOG-Z0071. | Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to treatment failure |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease progression |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate