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

NCT04661176 | Unknown DMC

• 1 other identifier: MIR-P003
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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

Prostate Cancer

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (2)

• Acceptability of the Sentinel™ PCC4 Assay for physicians assessing the prostate health in men

  To assess the acceptability of the miR Scientific Sentinel™ Prostate Cancer Classifier Platform (Sentinel™ PCC4 Assay) for physicians assessing the prostate health of men presenting with suspicion of prostate cancer including, but not limited to elevated serum Prostate Specific Antigen (PSA) level, suspicious DRE, family history of prostate cancer or germline mutation. The Sentinel™ PCC4 Assay is a urine exosome-based diagnostic/prognostic assay that identifies patients with no prostate cancer and classifies patients with prostate cancer into low, intermediate or high-risk disease.

  1 month after the intial 200 participants are accrued, and when 350 and 500 participants have been accrued.

• Validate the performance characteristics of the Sentinel™ PCC4 Assay in men in Puerto Rico

  Using the data collected as part of the primary study objective #1 to establish and validate the performance characteristics of the Sentinel™ PCC4 Assay in men in Puerto Rico.

  72 hours post sample receipt, urinary exosomal RNA samples will be extracted and analyzed using the Sentinel™ PCC4 Assay

Interventions

miR Sentinel™ PCC4 Assay DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Must be male to screen for prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of up to 500 male subjects will be enrolled from multiple clinical sites in Puerto Rico. Subjects will be men older than 22 with a core needle biopsy as part of routine clinical workup for initial diagnosis of prostate cancer.

You may qualify if:

• Males with suspicion of prostate cancer including, but not limited to elevated PSA level, suspicious DRE, family history of prostate cancer, and/or germline mutation.
• Signed informed consent prior to initiation of any study-related procedures.
• Minorities are included in this protocol.
• The patient provided a urine sample within 30 days prior to biopsy being performed.
• Patients who sign the consent form, but after shared decision making discussions with their urologist decide not to undergo a core needle biopsy. Since these may represent up to 5% of patients and represent the current SOC, these patients will be separately categorized as "Prostate Biopsy Declined" (PBD).

You may not qualify if:

• Persons younger than 22 years of age. Since patients with germline mutations and/or family history may want to be screened before the age of 45 (as recommended by the NCCN) and some men over the age of 75 individuals may request a diagnostic core needle biopsy after shared decision making with their urologist, we have chosen not to include an age range that may exclude these individuals. The lower age limit is designed to exclude children from the study.
• 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 finasteride or bicalutamide for BPH or male pattern baldness.

Sponsors & Collaborators

• miR Scientific LLC: lead

Study Sites (3)

San Juan Bautista School of Medicine Clinical Research Unit

Caguas, 00725, Puerto Rico

Location

Hospital Menonita de Caguas

Caguas, 00726, Puerto Rico

Location

Hospital Metropolitano Dr. Pila

Ponce, 00717, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine (one or more 50 mL samples) for Sentinel™ PCC4 Assay where urinary exosomal RNA will be extracted and retained for study analysis

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alvin Lopez-Pujals, MD

  San Juan Bautista School of Medicine Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: November 30, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

PR (3)