Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:

Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326216
• Other study ID #: 19-011292
• Secondary ID: NCI-2023-0522119
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

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