Measuring Prostate Cancer-Derived Extracellular Vesicles After Treatment
Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer
This study is testing how levels of prostate cancer-related particles in blood and urine change before and after treatment in men with prostate cancer, while also looking at how these levels relate to PSA levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06326216 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the levels of prostate cancer-derived extracellular vesicles in blood and urine samples from patients undergoing radical prostatectomy and neoadjuvant treatment. The study will compare these levels pre- and post-treatment and analyze their correlation with prostate-specific antigen (PSA) levels. Participants will be divided into cohorts based on their treatment type, and medical records will be reviewed to gather comprehensive data. Additionally, female control patients will also provide samples for comparison.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with high-risk prostate cancer who are undergoing primary prostatectomy.
Not a fit: Patients with metastatic prostate cancer or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of prostate cancer treatment responses and improve patient monitoring.
How similar studies have performed: Other studies have explored the role of extracellular vesicles in cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Eugene D. Kwon, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.