Prostate Carcinoma
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* PROSTATE CANCER PATIENTS: * Age 18+ * 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: * Age 18+ * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy | 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 |
| Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls | 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 | 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 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREugene D. Kwon, M.D.
Mayo Clinic in Rochester
Outcome results
None listed