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

N/AActive Not RecruitingNCT06326216

Mayo Clinic98 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Carcinoma

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Levels of prostate cancer-derived EVs will be assessed using blood and urine samples

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 extracellular vesicles (EVs) - negative controls

Levels of prostate cancer-derived EVs will be assess using blood and urine samples

Time frame: 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.

Time frame: 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).

Time frame: Baseline

Data from ClinicalTrials.gov

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