Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 805
- 试验地点
- 15
- 主要终点
- Binomial proportion of men on active surveillance without treatment
研究概览
简要总结
This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.
详细描述
All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.
Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.
After reviewing the results, patients and their treating physicians will decide on a management strategy.
Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.
FEB2026- Amendment was approved to decrease accrual from 900 to 800 as the study had been going on for longer than anticipated due to decreasing enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 diagnostic prostate biopsy in the past 9 months.
- •Prostate biopsy tumor tissue (FFPR block) available for processing
- •Age 18 years or older
- •PSA <20 ng/ml
- •Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
- •Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.
排除标准
- •Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
- •Nodal or metastatic prostate cancer (if staging imaging performed)
- •Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
- •Prior prostate gene expression classier testing
研究组 & 干预措施
Standard of care + pre-treatment genomics testing
Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.
干预措施: Prolaris (Device)
Standard of care + pre-treatment genomics testing
Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.
干预措施: Oncotype Dx Genomic Prostate Score (GPS) (Device)
Standard of care + pre-treatment genomics testing
Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.
干预措施: Standard of care (askMUSIC score) (Other)
Standard of care (no pre-treatment genomics testing)
Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).
干预措施: Standard of care (askMUSIC score) (Other)
Standard of care + pre-treatment genomics testing
Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.
干预措施: Decipher (Device)
结局指标
主要结局
Binomial proportion of men on active surveillance without treatment
时间窗: At 2 years
次要结局
- Mean score per arm of patient reported urinary function questionnaire(At 2 years)
- Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).(Baseline to 12 months and 2 years)
- Mean score per arm of patient reported sexual function questionnaire(At 2 years)
- Rate of indolent pathology(At time of prostatectomy (for patients who undergo procedure), up to 2 years)
- Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).(Baseline to 12 months and 2 years)
- Occurence of grade reclassification(At 2 years)
- Time to biochemical recurrence (BCR)(From time of radical therapy until the event or the last measured follow-up, up to 2 years)
- Time to distant metastases(From time of radical therapy until the event or the last measured follow-up, up to 2 years)
- Mean score per arm of health-related quality of life (HRQOL)(At 2 years)
- Rate of adverse pathology at prostatectomy(At time of prostatectomy, up to 5 years from enrollment)
- Rate of biochemical recurrence(Up to 5 years following treatment)