Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
NCT ID: NCT00052481
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2002-09-30
2004-04-30
Brief Summary
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PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.
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Detailed Description
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* 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Quality of life questionnaire
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.
quality-of-life assessment
Interventions
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quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Sandra G. Martin, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Walter Reed Army Medical Center
Washington D.C., 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
St 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
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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ACOSOG-Z0071
Identifier Type: -
Identifier Source: secondary_id
CDR0000258478
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0071
Identifier Type: -
Identifier Source: org_study_id
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