Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
This study has been completed.
Sponsor:
American College of Surgeons
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052481
First received: January 24, 2003
Last updated: February 18, 2011
Last verified: February 2004
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | September 2002 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 6 months since prior hormonal therapy for prostate cancer
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052481
Locations
| 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 | |
| Presbyterian Hospital | |
| 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 | |
Sponsors and Collaborators
American College of Surgeons
Investigators
| Study Chair: | Martin G. Sanda, MD | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00052481 History of Changes |
| Other Study ID Numbers: | CDR0000258478, ACOSOG-Z0071 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIB prostate cancer stage IIA prostate cancer adenocarcinoma of the prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013