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

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06326216
• Lead Sponsor: Mayo Clinic

Brief 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.

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.

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls	Baseline	Levels of prostate cancer-derived EVs will be assess using blood and urine samples
Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs	Baseline	PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis.
Prostate cancer-derived EV levels	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).
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy	Pre-surgery; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection until (optional)	Levels of prostate cancer-derived EVs will be assessed using blood and urine samples

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States