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

March 21, 2024 updated by: Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Eugene D. Kwon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with prostate cancer and undergoing prostatectomy as a local treatment and female patients seen in the Urology Clinic or female research volunteers.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (Cohort I)
Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.
Other: Non-Interventional Study
Non-interventional study
Observational (Cohort II)
Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
Time Frame: Pre-surgery; within two weeks after surgery; 6 weeks to 7 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
Pre-surgery; within two weeks after surgery; 6 weeks to 7 months after surgery (likely collected during routine visits); annual blood collection (optional)
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: 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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Eugene D. Kwon, M.D., Mayo Clinic in Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-011292 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2023-05221 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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