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Evaluation of the Sentinel™ PCC4 Assay for Diagnosis, Prognosis and Monitoring of Prostate Cancer in Puerto Rico

NCT04661176 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-10-25

No results posted yet for this study

Summary

The miR Scientific Sentinel™ Prostate Cancer Classifier Platform (Sentinel™ PCC4 Assay) is a new molecular assay that interrogates 442 small non-coding RNAs extracted from urinary exosomes and provides urologists an early, very precise indication of disease status in men presenting with suspicion of prostate cancer. The assay classifies the disease status as having no molecular evidence of prostate cancer (NMEPC) or molecular evidence of low-, intermediate- or high-risk of aggressive, potentially lethal prostate cancer.

The primary objective of this study is to assess the clarity of explanation of the biological background and clinical impact of the Sentinel™ PCC4 Assay, and the comfort level of urologists with the clinical data and report form, including the ease of understanding of results, and the potential use in clinical management of prostate cancer.

Men being seen by urologists in the course of their normal practice, presenting with suspicion of prostate cancer (based on DRE and/or elevated Prostate Specific Antigen (PSA)) and scheduled for core-needle biopsy will be asked to consent to the clinical study and provide one or more 50 mL sample of non-DRE urine along with relevant anonymized clinical data with the study team. The urine samples will be shipped to miR Scientific laboratories in Rensselaer NY, for exosomal sncRNA extraction and interrogation. The molecular status of the participant will be reported as a Sentinel™ PCC4 Risk Level.

The second primary objective of this study is to establish the performance characteristics of the Sentinel™ PCC4 Assay in the Puerto Rican population for identifying men with NMEPC, and men with evidence of high-risk prostate cancer.

Participants will receive the standard of care (SOC), including measurement of PSA, DRE and TRUS-guided systematic or MRI-guided targeted biopsy. Based on the histopathology report of the core-needle biopsy, read by pathologists associated with local institution, participants with no positive cores will be designated "cancer-free"; otherwise patients with cancer in one or more cores will have the clinical data associated with the SOC collected (including the Gleason grade group, tumor staging, PSA, race and CAPRA risk assessment score). The CAPRA score will be compared to the molecular classification provided by the Sentinel™ PCC4 Assay.

Conditions

Interventions

DIAGNOSTIC_TEST

miR Sentinel™ PCC4 Assay

This study is a prospective clinical utility study. Urine samples will be collected from participants for the miR Sentinel™ PCC4 Assay, which interrogates the expression profile of 442 small non-coding RNAs to classify disease status as having no molecular evidence of prostate cancer (NMEPC) or molecular evidence of low-, intermediate- or high-risk prostate cancer.

Sponsors & Collaborators

  • miR Scientific LLC

    lead INDUSTRY

Principal Investigators

  • Alvin Lopez-Pujals, MD · San Juan Bautista School of Medicine Clinical Research Unit

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661176 on ClinicalTrials.gov