- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177865
Study of Treatment Choice in Patients With Localized Prostate Cancer
Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
RATIONALE: Gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options.
PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, WIT 3AA
- Recruiting
- University College of London Hospitals
-
Contact:
- Contact Person
- Phone Number: 44-20-7380-9194
- Email: markemberton1@btinternet.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
|
Treatment choice in respect to risks to sexual function and urinary function, return to normal activities, aim to treat the whole gland or only cancer areas or important cancer areas, retreatment rate, and mortality rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000682206
- UCL-COMPARE
- EU-21055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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