Study of Treatment Choice in Patients With Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
informational intervention
questionnaire administration
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Eligibility Criteria
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
Sites / Locations
- University College of London HospitalsRecruiting
Outcomes
Primary Outcome Measures
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
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
Full Information
NCT ID
NCT01177865
First Posted
August 6, 2010
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01177865
Brief Title
Study of Treatment Choice in Patients With Localized Prostate Cancer
Official Title
Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University College London Hospitals
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
432 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
Title
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 Measure Information:
Title
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Emberton, MD, FRCS, MBBS
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-7380-9194
Email
markemberton1@btinternet.com
12. IPD Sharing Statement
Learn more about this trial
Study of Treatment Choice in Patients With Localized Prostate Cancer
We'll reach out to this number within 24 hrs