Study of Treatment Choice in Patients With Localized Prostate Cancer
NCT ID: NCT01177865
Last Updated: 2013-08-26
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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UNKNOWN
NA
432 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.
Detailed Description
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Primary
* To evaluate the importance of prostate cancer treatment characteristics to men with localized prostate cancer.
* To determine to what extent men will choose the strengths and weaknesses of one treatment over a different set of strengths and weaknesses of another treatment when making a choice between them.
Secondary
* To determine the correlation between attributes that are important to men and baseline demographics, functional status, and disease risk characteristics.
OUTLINE: This is a multicenter study.
Patients complete a 'discrete choice experiment' questionnaire presenting three treatment options based on 8 aspects of treatment. Attributes relevant to men with prostate cancer (e.g., sexual health, urinary function, return to normal activities \[work, gardening, sports, shopping\]) that apply to surveillance, radical therapies and new minimally-invasive therapies have been selected for consideration. Baseline demographics such as age, working/retired/unemployed/household income, prostate cancer characteristics (PSA level, Gleason grade, stage), baseline functional status (genitourinary function), and final treatment choice will also be collected in order to ascertain whether there is any relationship and association between patient preferences for treatment and these baseline demographics. Individuals will be asked to choose between the three treatment profiles.
Conditions
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Keywords
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Study Design
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HEALTH_SERVICES_RESEARCH
Interventions
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informational intervention
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies
* Clinical stage ≤ T2c N0 M0 (radiological T3a allowed)
* Local staging imaging as per guidelines to demonstrate localized disease (e.g., MRI, CT, and/or bone scan)
* No metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* No prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer
* Gleason grade ≤ 7
* Serum PSA ≤ 15 ng/mL
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy
* No androgen suppression/hormone treatment within the previous 12 months for prostate cancer
45 Years
80 Years
MALE
No
Sponsors
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University College London Hospitals
OTHER
Principal Investigators
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Mark Emberton, MD, FRCS, MBBS
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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University College of London Hospitals
London, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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UCL-COMPARE
Identifier Type: -
Identifier Source: secondary_id
EU-21055
Identifier Type: -
Identifier Source: secondary_id
CDR0000682206
Identifier Type: -
Identifier Source: org_study_id