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| ID | Type | Description | Link |
|---|---|---|---|
| UCL-COMPARE | |||
| EU-21055 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| informational intervention | Other | |||
| questionnaire administration | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics |
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DISEASE CHARACTERISTICS:
Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies
Clinical stage ≤ T2c N0 M0 (radiological T3a allowed)
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Emberton, MD, FRCS, MBBS | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College of London Hospitals | Recruiting | London | England | WIT 3AA | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |