Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
研究概览
简要总结
This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the levels of prostate cancer-derived extracellular vesicles pre- and post-RP.
II. Determine the correlation between levels of prostate cancer-derived extracellular vesicles and PSA.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.
COHORT I (RADICAL PROSTATECTOMY): Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PROSTATE CANCER PATIENTS:
- •Able to give informed consent
- •Patients with prostate cancer
- •Patients treated with primary prostatectomy
- •The focus will be on high-risk patients with at least one of either criterion:
- •PSA >= 20 ng/ml
- •AND/OR Gleason >= 8
- •AND/OR clinical stage >= T3
- •FEMALE CONTROL PATIENTS:
- •Able to give informed consent
排除标准
- •PROSTATE CANCER PATIENTS:
- •Unable or unwilling to provide informed consent
- •Metastatic prostate cancer - defined evidence of metastatic disease on pre-procedural testing
- •FEMALE CONTROL PATIENTS:
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Observational (Cohort I)
Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.
干预措施: Non-Interventional Study (Other)
Observational (Cohort III)
Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.
干预措施: Non-Interventional Study (Other)
Observational (Cohort II)
Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.
结局指标
主要结局
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
时间窗: Baseline
Levels of prostate cancer-derived EVs will be assess using blood and urine samples
Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
时间窗: Baseline
PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis.
Prostate cancer-derived EV levels
时间窗: Baseline
Prostate cancer-derived EV levels will be determined from blood and urine samples and will be assessed by comparative analysis between prostate cancer patients and female patients (negative controls).
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
时间窗: Baseline
Levels of prostate cancer-derived EVs will be assess using blood and urine samples
Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
时间窗: Baseline
PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis.
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
时间窗: Pre-surgery; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection (optional)
Levels of prostate cancer-derived EVs will be assessed using blood and urine samples
Prostate cancer-derived EV levels
时间窗: Baseline
Prostate cancer-derived EV levels will be determined from blood and urine samples and will be assessed by comparative analysis between prostate cancer patients and female patients (negative controls).
次要结局
未报告次要终点