A Study To Determine Baseline Levels For Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-011292
NCT ID: NCT06326216
Sponsor Protocol Number: 19-011292
About this study
The purposes of this study are to determine the levels of prostate cancer-derived extracellular vesicles pre- and post-local therapy (radical prostatectomy or radiation therapy), to correlate analysis for PSA levels and prostate cancer-derived extracellular vesicles, and to determine baseline levels of prostate cancer-derived extracellular vesicles in patients undergoing different lines of primary local treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18+ years of age.
- Able to give informed consent.
Prostate Cancer Patients
- Patients with intermediate-risk, high-risk or very-high risk prostate cancer (≥ Grade Group 2).
- Patients scheduled to undergo open radical prostatectomy (ORP).
- Patients scheduled to undergo conventional laparoscopic radical prostatectomy (LRP).
- Patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RALP).
- Patients scheduled to undergo external beam radiation therapy (EBRT).
Nephrolithiasis Patients
- Patients treated for nephrolithiasis (Extracorporeal Shock Wave Lithotripsy/Surgery).
Exclusion Criteria:
Prostate Cancer patients
- Unable or unwilling to provide informed consent.
- On hormone therapy (Casodex, GnRH agonist/antagonist).
- Patients with Benign Prostatic Hyperplasia (BPH).
- Active (non-skin) malignancy within the past 5 years excluding prostate cancer.
- Metastatic prostate cancer – defined as pathologic N+ on final pathology or radiographic evidence of metastatic disease on pre-procedural testing.
Nephrolithiasis Patients
- Unable or unwilling to provide informed consent.
- History of Benign Prostatic Hypertrophy (BPH).
- Active (non-skin) malignancy within the past 5 years including prostate cancer.
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Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Eugene Kwon, M.D. |
Closed for enrollment |
Contact information:
Tami Krpata
5074225768
Contact Uskrpata.tami@mayo.edu
|
More information
Publications
Publications are currently not available