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临床试验/NCT00421265
NCT00421265Unknown不适用

Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年1月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1

研究概览

简要总结

In patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. Active surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. We hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Prospective

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion
  • Gleason's score of 6 or less.
  • Clinical T1C per digital rectal exam.
  • Pre biopsy PSA serum level of 6.0ng/ml or less.
  • The presence of cancer in a single biopsy core of at least 8 taken.
  • The presence of cancer in no more than 10% of the length of the core involved.
  • Patient's consent to engage in active surveillance after being informed of the benefits and potential risks of this approach as well as of alternative lines of therapy.
  • Israeli residence with the readiness to be available for the followup schedule.

排除标准

  • Patients who do not meet the above eligibility criteria

研究者

申办方类型
Other Gov

研究点 (1)

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