Prostate CancerNCT01177865
Study of Treatment Choice in Patients With Localized Prostate Cancer
A study testing informational intervention and questionnaire administration in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- informational intervention and questionnaire administration
- How many people
- 432 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College of London Hospitals
London, England, WIT 3AA
Contact Person, 44-20-7380-9194, markemberton1@btinternet.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- informational intervention, questionnaire administration
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informational interventionOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Mark Emberton, MD, FRCS, MBBS, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177865
- Sponsor's protocol ID
- CDR0000682206
- Other IDs
- UCL-COMPARE, EU-21055
- Status last verified
- Nov 2010
- First submitted
- 6 Aug 2010
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
- ClinicalTrials.gov ID
- NCT01177865
- Acronym / sponsor ID
- CDR0000682206
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| informational intervention | Other | – |
| questionnaire administration | Other | – |
Primary outcome
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
1 secondary outcome
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University College of London Hospitals
London, United Kingdom
Mark Emberton, MD, FRCS, MBBS principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing informational intervention and questionnaire administration in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.