Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
2 other identifiers
observational
500
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2002
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 24, 2003
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedJuly 6, 2016
July 1, 2016
1.6 years
January 24, 2003
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to treatment failure
Up to 10 years
Secondary Outcomes (1)
disease progression
Up to 10 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients diagnosed with adenocarcinoma of the prostate and previously enrolled on ACOSOG-Z0070.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (13)
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1062, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Presbyterian Hospital
Charlotte, North Carolina, 28233-3549, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sandra G. Martin, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2003
First Posted
January 27, 2003
Study Start
September 1, 2002
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
July 6, 2016
Record last verified: 2016-07