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NCT Number: NCT06326216

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy

    Time frame: 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 EVs will be assessed using blood and urine samples

  2. 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

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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