Comparing a Standard of Care Prostate Biopsy System With a Novel System Using Standard as Well as Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Atypical Small Acinar Proliferation
研究概览
简要总结
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.
详细描述
Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.
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
- Single (Outcomes Assessor)
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
- •Adult males with PSA density greater than or equal to 0.15
- •Lesions are visible under MRI
- •PIRADS score is greater than or equal to 3
- •Able to and willing to provide consent
排除标准
- •Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
- •History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
- •Is a prisoner currently or has a history of incarceration
- •Unable to understand English
- •Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
- •Has concurrent malignancies
- •Is positive for HIV, HBV, and/or HCV infection
- •Has low-performance status
研究组 & 干预措施
Test group
The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.
干预措施: Novel needle biopsy catheter (test) (Device)
Single Arm
The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.
干预措施: Novel needle biopsy catheter (test) (Device)
结局指标
主要结局
Atypical Small Acinar Proliferation
时间窗: From enrollment to end of treatment at 1 day
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
Gleason Score
时间窗: From enrollment to end of treatment at 1 day
Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
Tissue area and length
时间窗: From treatment to end of pathology review at 2 days
The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
Tissue toruosity
时间窗: From treatment to end of pathology review at 2 days
Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.
次要结局
- Standard Pathology versus Computational Pathology Results(From treatment to end of pathology review at 2 days)