Clinical trial NCT06326216: Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
Official title: Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
timeFrame: Pre-surgery; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection until (optional)
measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
timeFrame: Baseline
measure: Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
timeFrame: Baseline
measure: Prostate cancer-derived EV levels
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Eugene D. Kwon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: