NCT01177865Unknown不适用
Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
University College London Hospitals2 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 432
- 试验地点
- 2
- 主要终点
- Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Health Services Research
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
次要结局
- Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
研究者
研究点 (2)
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