NCT02080689已完成不适用
PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]
GenomeDx Biosciences Corp37 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 37
- 主要终点
- Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
研究概览
简要总结
The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR
详细描述
This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP:
- In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
- In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)
A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases.
As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathological T3 stage of disease (i.e., EPE or SVI), or
- •Positive surgical margins, or
- •Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
排除标准
- •For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
- •For salvage setting patients: Metastatic Disease at PSA rise
- •Failure of PSA to nadir after surgery
- •Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
- •Received any adjuvant chemotherapy
- •Required patient clinical data is not available for evaluation of eligibility criteria
- •For adjuvant setting patients, any treatment received after surgery
- •For salvage setting patients, lack of documented treatment or management recommendation on file
- •Tissue specimen is inadequate for sampling and analysis
结局指标
主要结局
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
时间窗: 3 months
次要结局
- Frequency of follow visits as a measure of reproducibility(12 months)
- Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool(3 months)
- The number of different treatment plans most influenced by Decipher as a measure of clinical utility(12 months)
- Measure the number of participants for which treatment was Increased or decreased in the intensity.(3 months)
- Account for the number of specific treatment assignments that correlated with a change in treatment recommendation(12 months)
- Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance(12 months)
- Evaluate number of participants which show coherence to treatment decisions(12 months)
- Comparison of type of treatment plans between high risk and low risk patients(6 months)
- A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients(12 months)
研究者
研究点 (37)
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