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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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London, England, Reino Unido, WIT 3AA
- Reclutamiento
- University College of London Hospitals
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Contacto:
- Contact Person
- Número de teléfono: 44-20-7380-9194
- Correo electrónico: markemberton1@btinternet.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
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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
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Medidas de resultado secundarias
Medida de resultado |
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Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000682206
- UCL-COMPARE
- EU-21055
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