UAB-NCI Collaborative Study on Integrating Genomic Prostate Score With MRI Targeted Prostate Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- relationship between continuous GPS score and occult high-risk disease
研究概览
简要总结
Background:
Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further.
Objective:
To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer.
Eligibility:
Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers.
Design:
This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used.
Tumor tissue will be tested with the GPS.
Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results.
Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards....
详细描述
Background:
- Prostate cancer is one of the most common malignancies occurring in men. While many men will qualify for active surveillance (AS), those with intermediate risk disease are often recommended definitive therapy despite the morbidity.
- Focal therapy for prostate cancer has been promoted as an alternative to the standard paradigm of immediate radical prostatectomy (RP) versus AS for prostate cancer management. Focal therapy treats the areas of cancer selectively, leaving the remainder of the prostate intact.
- While focal therapy offers great promise in terms of minimizing side effects and helping prostate cancer patients avoid radical therapies, careful patient selection is required.
- The Oncotype DX Genomic Prostate Score (GPS) assay was developed using the ability to extract and amplify RNA of sufficient quantity and quality from the very small amounts of prostate tumor tissue from biopsy samples. Using these samples, a discovery study identified 12 cancerrelated genes associated with multiple clinically relevant endpoints including adverse pathology, biochemical recurrence, clinical recurrence, and prostate cancer associated death.
- The GPS assay uses these 12 genes and 5 reference genes to construct an algorithm giving a score from 0-100 to predict the likelihood of adverse pathology.
- The goal of this study is to evaluate how GPS may be useful in conjunction with MRI to improve patient selection for focal therapy of prostate cancer.
Objectives:
-To determine if there is a positive association between continuous GPS score and occult high risk and/or non-organ confined disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on multiparameter MRI (mpMRI)
Eligibility:
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
- 否
入选标准
- •INCLUSION CRITERIA:
- •Samples and images from men > =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay
- •Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy
- •3Tesla MRI with/without coil performed within 6 months preceding diagnostic biopsy
- •Availability of diagnostic biopsy
排除标准
- •Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition
- •Men with NCCN high risk or very high-risk prostate cancer
- •Biopsy Gleason 8
- •No biopsy tissue available
- •Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review
- •Missing diagnostic PSA
- •Missing clinical T stage
- •Known lymph node positive or metastatic disease at time of diagnosis
- •Missing MRI 6 months before diagnostic biopsy
研究组 & 干预措施
GPS Cohort 1
Samples and images from up to 277 evaluable patients diagnosed with NCCN low or intermediate risk prostate cancer, Gleason <= 7, managed with RP, and mpMRI within 6 months prior to prostatectomy
结局指标
主要结局
relationship between continuous GPS score and occult high-risk disease
时间窗: 2-3 years
To determine if there is a positive relationship between continuous GPS score and occult high-risk disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on mpMRI
次要结局
- distributions of clinical, pathological and demographic variables(2-3 years)