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临床试验/NCT01525914
NCT01525914已完成不适用

Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
change in serum PSA

研究概览

简要总结

Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer.

The study will determine the prevalence of a secondary rise in PSA > 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.

详细描述

This analysis is a subset of the data associated with the active surveillance cohort at Sunnybrook Health Sciences Centre. Approximately 150 subjects within the cohort have received dutasteride therapy from 6 months to 3 years. All subjects have had serial PSAs at regular intervals between 3 to 6 months, and all have had a biopsy performed within 1 to 3 years of initiating dutasteride. The prevalence of a secondary rise in PSA > 0.5ng/ml will be calculated with the impact of dutasteride therapy on the PSA doubling time. This information will be correlated with baseline PSA value, prostate volume, extent of disease on initial biopsy and baseline PSA kinetics. PSA kinetics will be also correlated with Gleason score upgrading on repeat biopsy. The rate of negative biopsies in men on dutasteride therapy will be compared with a similar group of surveillance subjects not treated with dutasteride.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.

排除标准

  • 未提供

研究组 & 干预措施

dutasteride, active surveillance

men with favorable risk prostate cancer on surveillance treated with dutasteride

干预措施: Dutasteride (Drug)

结局指标

主要结局

change in serum PSA

时间窗: change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months

The time that the change in serum PSA from baseline to the secondary rise will be used to determine the PSA 'kinetics' in men on surveillance for prostate cancer.

次要结局

  • rate of secondary rise in serum PSA(at 6 months after starting dutasteride therapy)

研究者

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

Dr. Laurence Klotz

Principal Investigator

Sunnybrook Health Sciences Centre

研究点 (1)

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