Identification of Clinically Insignificant or Significant Prostate Cancer With the miR Scientific Sentinel™ Platform

Status unconfirmed

Conditions studied: Prostate Cancer

In brief

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 Antigen (PSA), and/or family medical history of prostate cancer, among other reasons) and who meet the inclusion/exclusion criteria will be asked to consent to the clinical study and provide a 40-60 mL urine sample, without prior DRE, along with relevant de-identified clinical data, at the time of the initial consultation, prior to core-needle biopsy. The miR Scientific Sentinel® Prostate Cancer Classifier Platform (Sentinel® PCC4 Test) is a new molecular test that interrogates 442 small non-coding RNAs (sncRNA) extracted from urinary exosomes. Using the expression levels of 442 sncRNAs isolated from urine exosomes, the Sentinel® PCC4 Test provides an initial classification of disease status as either no molecular evidence of prostate cancer (NMEPC), or molecular evidence (MEPC) of low-, intermediate- or high-risk of aggressive prostate cancer. This study is designed to validate the classification algorithm and finalize the performance characteristics of the Test using risk-group labeling based on pathological grading from core-needle biopsy data.

Key facts

Study ID

NCT04100811

Run by

miR Scientific LLC

People needed

2019

Starts

2019-12-01

Expected to finish

2024-12-31

Last updated by the study team

2023-10-25

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Georgia Urology — Atlanta, Georgia, United States
• Urology of Greater Atlanta — Stockbridge, Georgia, United States
• Integrated Medical Professionals — Farmingdale, New York, United States

Full record on ClinicalTrials.gov

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