Quantification and Purification of Circulating Prostasomes as Diagnostic Tool for Prostate Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- sensitivity of the prostasome purification methodology
研究概览
简要总结
Prostate cancer is the most frequently diagnosed cancer among men over 50 years old in Western societies, with an incidence that is steadily increasing in most countries. The current, most commonly used biomarker for prostate cancer is prostate specific antigen (PSA), which has well known limitations in accuracy and requires additional testing. However, prostate cancer cells secrete exosomes, also known as prostasomes, which are only detectable in the blood of prostate cancer patients. The presence of prostasomes in the blood is in itself a prostate cancer diagnosis. However, the assay that has been designed for the purification of prostasomes requires additional testing for evaluating its robustness and usefulness in the clinical setting. Additionally, the evaluation of the cargo of the purified prostasomes may provide more information on the nature of the prostate cancer, which may help develop a molecular assay for a prostate cancer liquid biopsy rather than a tissue biopsy. Therefore, the purpose of this study is two-fold: a validation phase where the purification of prostasomes will be tested on plasma collected from prostate cancer patients and a molecular testing phase where the contents of the purified prostasomes will be evaluated on their ability to determine the grade of the prostate tumors.
We will collaborate with Dr. Masood Kamali-Moghaddam at the Uppsala University (Department of Immunology, Genetics and Pathology) for molecular assay processing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •With elevated PSA or patients with diagnosed prostate cancer
- •18 years and older
- •Willingness to participate in the study and compliance with protocol requirements
- •Have not received any type of treatment for prostate cancer
排除标准
- •Patients with confirmed or suspected prostate cancer that have already received any type of treatment
- •Patients with another primary cancer within the past five years of prostate cancer diagnosis. However, superficial skin cancers such as basal cell or squamous cell cancers would not exclude a patient.
研究组 & 干预措施
Patient population
Male individuals with elevated PSA and a positive MRI-driven biopsy AND male individuals with diagnosed prostate cancer (but prior to any treatment)
干预措施: Genetic analysis for the detection of prostasomes (Diagnostic Test)
Control Population
Male individuals with elevated PSA and a negative MRI-driven biopsy
干预措施: Genetic analysis for the detection of prostasomes (Diagnostic Test)
结局指标
主要结局
sensitivity of the prostasome purification methodology
时间窗: through study completion - up to 24 months
true positive rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls)
specificity of the prostasome purification methodology
时间窗: through study completion - up to 24 months
true negative rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls)
次要结局
- Time to disease progression(in patient cohort only)(Up to 24 months)
- Time to disease relapse (in patient cohort only)(Up to 24 months)
- Overall survival (in patient cohort only)(Up to 24 months)
- Quantification of the miRNA expression profiles of the purified protostomes both before and after treatment (in patients cohort only)(through study completion - up to 24 months)