Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
130Conditions
Prostate CarcinomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Eugene D. Kwon, M.D.
Eligibility Criteria
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
Study Plan
Observational (Cohort I)
Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational (Cohort III)
Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational (Cohort II)
Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.
Outcome Measures
Primary Outcome Measures
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
Prostate cancer-derived EV levels
Timeline
Last Updated
February 10, 2025Start Date
March 22, 2024Today
May 9, 2025Completion Date ( Estimated )
July 1, 2025
Sponsors of this trial
Lead Sponsor
Mayo Clinic
RECRUITING 
≥ 18 Years