Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy|
- time to treatment failure [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- disease progression [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
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.
|Procedure: quality-of-life assessment|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052481
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0128|
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1062|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28233-3549|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Vermont|
|Fletcher Allen Health Care - Medical Center Campus|
|Burlington, Vermont, United States, 05401|
|United States, Virginia|
|Sentara Norfolk General Hospital|
|Norfolk, Virginia, United States, 23507|
|United States, Washington|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431-5048|
|Study Chair:||Sandra G. Martin, MD||Beth Israel Deaconess Medical Center|