Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 13
- 主要终点
- Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
研究概览
简要总结
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
详细描述
This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.
The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients who have undergone radical prostatectomy
- •PSA < 0.1 ng/ml at enrollment
- •At least one of the following:
- •pT3 (seminal vesicle invasion or extraprostatic extension), or
- •Positive surgical margins
- •Radical prostatectomy within one year of enrollment
排除标准
- •Individuals who have any of the following will not be eligible to participate:
- •Have regional or distant metastatic disease
- •Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
- •Node positive
研究组 & 干预措施
GC (Decipher) Arm
If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
干预措施: Decipher Prostate Cancer Classifier (Other)
Usual-Care-Based (UC) Arm
If enrolled during the UC period, only the CAPRA-S results will be provided.
结局指标
主要结局
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
时间窗: within 18 months of radical prostatectomy
Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.
次要结局
- Time (From Randomization) to Adjuvant Treatment Administration(Up to 18 months post randomization)
- Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)(Up to 24 months post radical prostatectomy)
- Time (From Randomization) to Salvage Treatment Administration(Up to 5 years post randomization)
- Time (From Randomization) to Biochemical Recurrence (BCR)(Up to 5 years post randomization)
- Time (From Randomization) to Metastatic Disease (Regional or Distant)(Up to 5 years post randomization)