NCT05180305Unknown不适用
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mitomic Prostate Test (MPT)
研究概览
简要总结
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.
详细描述
To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA < 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA < 10ng/ml within the previous 3 months.
- •Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
- •Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
- •The index biopsy must occur following and within 16 weeks of blood draw.
排除标准
- •Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
- •Previous diagnosis of prostate cancer;
- •Prostate biopsy within the previous 3 months;
- •Men with a total PSA>10ng/ml within the previous 3 months;
- •Provides less than the required amount of blood;
- •Considered incompetent to provide informed consent;
- •Does not understand and read language of informed consent;
- •Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
- •Males who are not of screening age (<45);
- •Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
- •Blood collected after index biopsy.
- •Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.
结局指标
主要结局
Mitomic Prostate Test (MPT)
时间窗: 16 weeks
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.
次要结局
- MPT compared to the current standard of care (SOC).(16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Multi-Modal Image Fusion for Precision Prostate Biopsy NavigationProstate CancerNCT06441292Shanghai East Hospital602
Unknown
3 期
The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-firingProstate CancerNCT00851292Amphia Hospital800
已完成
不适用
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer DiagnosticPatients With Suspected Prostate CancerNCT05763355Elsan101
已完成
2 期
Targeted Fusion Biopsy of the ProstateProstatic NeoplasmsNCT02744534Emory University21
Unknown
不适用
MR-targeted vs. Random TRUS-guided Prostate BiopsyProstate CancerNCT02678481Fondazione del Piemonte per l'Oncologia90