NCT06326216

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2020Dec 2026

Study Start

First participant enrolled

June 10, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

March 15, 2024

Last Update Submit

April 20, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (4)

  • 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; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection (optional)

  • 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

  • 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

  • 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

Study Arms (3)

Observational (Cohort I)

Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.

Other: Non-Interventional Study

Observational (Cohort III)

Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.

Other: Non-Interventional Study

Observational (Cohort II)

Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational (Cohort I)Observational (Cohort III)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

With permission of participant, blood and urine samples may be retained for use in future research.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Eugene D. Kwon, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 22, 2024

Study Start

June 10, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)