Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 8
- 主要终点
- Rate of BCR or metastasis after selection of active surveillance (AS)
研究概览
简要总结
Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.
详细描述
This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.
The primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.
The secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1,
- •Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.
- •Have NCCN low-risk disease2.
排除标准
- •Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.
- •Over 80 years of age at diagnosis.
- •History of hypogonadism at the time of diagnosis.
- •Co-occurring malignancy, excluding non-melanoma skin cancer.
- •Enrolled in another investigational study.
结局指标
主要结局
Rate of BCR or metastasis after selection of active surveillance (AS)
时间窗: Up to five years post Prolaris report
This study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men.
次要结局
未报告次要终点