Surveillance or Focal Therapy (SOFT) for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Treatment choice
研究概览
简要总结
Patients with newly diagnosed low-intermediate risk prostate cancer often are not advised of all the options in an easy to understand way. This trial will show patients a 2 minute animated Explainer video to better understand their treatment options. Patients will choose their treatment choice (surveillance, focal therapy, or standard treatment option) and we will determine disease related anxiety and decision regret scores.
详细描述
Low risk prostate cancer is usually monitored with active surveillance (AS). Some evidence suggests no differences in health-related quality of life (HRQoL) and wellness between men undergoing AS and those receiving treatment. However, other studies have shown a significant subset of patients suffers from anxiety or depression related to disease uncertainty. Many patients are given an "all-or-none" binary choice between monitoring or radical treatment. Focal therapy (FT), however, is a potentially less intense treatment option that exists between these extreme choices but is not always presented to the patient due to provider variability. This study seeks to define the proportion of newly diagnosed low/low-int risk prostate cancer patients who elect to pursue HIFU or surveillance when presented with all treatment options devoid of persuasive rhetoric using an animated explainer video. Secondary outcomes will include anxiety score and decision regret.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Gleason 3+3 (GG 1) or 3+4 (GG2)
- •Prostate < 60cc
- •MRI non-focal or PIRADS 3-4 in peripheral gland
- •Absence of significant anterior disease
排除标准
- •Anal stenosis
- •Prostatic calfcifations
- •Latex allergy
- •Gleason grade group 3-5
- •Multifocal or anterior disease
- •Prostate > 60 cc
结局指标
主要结局
Treatment choice
时间窗: 12 months
Incidence of surveillance, focal therapy, or other treatment choice
次要结局
- Decision regret and anxiety scale(12 months)
研究者
David S Finley, MD
Associate Professor of Urology
Kaiser Permanente
