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临床试验/NCT07207902
NCT07207902进行中(未招募)不适用

Surveillance or Focal Therapy (SOFT) for Prostate Cancer

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David S Finley, MD

Associate Professor of Urology

Kaiser Permanente

研究点 (2)

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