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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (Cohort I) | Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed. |
| |
| Observational (Cohort III) | Female urology clinic patients and female volunteers undergo blood and urine sample collection on study. |
| |
| Observational (Cohort II) | Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy | Levels of prostate cancer-derived EVs will be assessed using blood and urine samples | 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 extracellular vesicles (EVs) - negative controls | Levels of prostate cancer-derived EVs will be assess using blood and urine samples | Baseline |
| Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs | PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis. | Baseline |
| Prostate cancer-derived EV levels | 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). | Baseline |
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Inclusion Criteria:
PROSTATE CANCER PATIENTS:
Age 18+
Able to give informed consent
Patients with prostate cancer
Patients treated with primary prostatectomy
PSA >= 20 ng/ml
AND/OR Gleason >= 8
AND/OR clinical stage >= T3
FEMALE CONTROL PATIENTS:
Exclusion Criteria:
PROSTATE CANCER PATIENTS:
FEMALE CONTROL PATIENTS:
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Patients with prostate cancer and undergoing prostatectomy as a local treatment and female patients seen in the Urology Clinic or female research volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Eugene D. Kwon, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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With permission of participant, blood and urine samples may be retained for use in future research.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |