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

Mayo Clinic

Status: Active, not recruiting

Conditions: Prostate Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06326216

19-011292 (Other Identifier)

NCI-2023-05221 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

98 participants in 3 patient groups

Observational (Cohort I)

Description:

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

Treatment:

Other: Non-Interventional Study

Observational (Cohort III)

Description:

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

Treatment:

Other: Non-Interventional Study

Observational (Cohort II)

Description:

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