Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Non-Interventional Study
- Conditions
- Prostate Carcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
- Status
- Active, not recruiting
- Last Updated
- 9 days ago
Overview
Brief Summary
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.
Detailed Description
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. COHORT II (NEOADJUVANT): Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed. COHORT III (NEGATIVE CONTROLS): Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Observational (Cohort I)
Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.
Intervention: Non-Interventional Study
Observational (Cohort III)
Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.
Intervention: Non-Interventional Study
Observational (Cohort II)
Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.
Outcomes
Primary Outcomes
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).