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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06326216
Other study ID # 19-011292
Secondary ID NCI-2023-0522119
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2020
Est. completion date July 1, 2025

Study information

Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES: I. Determine the levels of prostate cancer-derived extracellular vesicles pre- and post-radical prostatectomy. 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: Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed. COHORT II: Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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; within two weeks after surgery; 6 weeks to 7 months after surgery (likely collected during routine visits); annual blood collection (optional)
Primary 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
Primary 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
Primary 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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