Prostate CarcinomaNCT06326216
Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
An observational study of Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 12Show fewer
- PSA >= 20 ng/ml
- AND/OR Gleason >= 8
- AND/OR clinical stage >= T3
- FEMALE CONTROL PATIENTS:
- Age 18+
- Able to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational (Cohort I) | Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed. Receives: Other: Non-Interventional Study | |
| Observational (Cohort III) | Female urology clinic patients and female volunteers undergo blood and urine sample collection on study. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
Levels of prostate cancer-derived EVs will be assessed using blood and urine samples
Measured: 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
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Jun 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene D. Kwon, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326216
- Sponsor's protocol ID
- 19-011292
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06326216
- Acronym / sponsor ID
- 19-011292
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational (Cohort I) | – | Other: Non-Interventional StudyProstate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed. |
| Observational (Cohort III) | – | Other: Non-Interventional StudyFemale urology clinic patients and female volunteers undergo blood and urine sample collection on study. |
| Observational (Cohort II) | – | –Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- PROSTATE CANCER PATIENTS:
- FEMALE CONTROL PATIENTS:
Key exclusion criteria (5 listed)
- PROSTATE CANCER PATIENTS:
- FEMALE CONTROL PATIENTS:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational (Cohort I), Observational (Cohort III) |
Primary outcome
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy
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 EVs will be assessed using blood and urine samples
Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls
Time frame: Baseline
Levels of prostate cancer-derived EVs will be assess using blood and urine samples
Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs
Time frame: Baseline
PSA levels and EVs will be determined from blood and urine samples and will be assessed by correlation analysis.
Prostate cancer-derived EV levels
Time frame: Baseline
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Prostate Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene D. Kwon, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy (time frame: Pre-surgery; once post-surgery, 6 weeks to 6 months after surgery (likely collected during routine visits); annual blood collection (optional)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.