Status:
UNKNOWN
Identification of Clinically Insignificant or Significant Prostate Cancer With the miR Scientific Sentinel™ Platform
Lead Sponsor:
miR Scientific LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
45+ years
Brief Summary
In this non-interventional study, men being seen by urologists in the course of their normal practice that present with clinical suspicion of prostate cancer (based on DRE, elevated Prostate Specific ...
Detailed Description
The miR Scientific Sentinel® Prostate Cancer Classifier Platform (Sentinel® PCC4 Test) is a new molecular test that interrogates 442 small non-coding RNAs extracted from urinary exosomes. The Sentinel...
Eligibility Criteria
Inclusion
- Males ≥ 45 years old
- Males with clinical suspicion of prostate cancer, including but not limited to elevated PSA level, suspicious DRE, family history of prostate cancer, and/or germline mutation, who as a result undergo TRUS- or MRI-guided core-needle biopsy and PSA recording (for NCCN group label).
- Signed informed consent prior to initiation of any study-related procedures.
- The patient provided a voided urine sample within 30 days prior to biopsy being performed and prior to DRE (if any). This collection must be ≥ 1 hour after the last urination.
Exclusion
- Persons previously diagnosed with prostate cancer.
- Persons who have previously undergone a 12 core or fusion biopsy in the last 12 months
- Persons who have had a DRE within 72 hours of the urine collection
- Persons incapable of providing informed consent.
- Persons presenting with clinical symptoms of urinary tract infection, including prostatitis at the time of enrollment.
- Persons with prior history of invasive treatment for benign prostatic hyperplasia within 3-6 months of study enrollment.
- Patients treated with a 5-alpha-reductase inhibitor, Saw Palmetto for BPH or male pattern baldness within 3 months of the urine collection.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
2019 Patients enrolled
Trial Details
Trial ID
NCT04100811
Start Date
December 1 2019
End Date
December 31 2024
Last Update
October 25 2023
Active Locations (3)
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1
Georgia Urology
Atlanta, Georgia, United States, 30328
2
Urology of Greater Atlanta
Stockbridge, Georgia, United States, 30281
3
Integrated Medical Professionals
Farmingdale, New York, United States, 11735