Evaluation of the Sentinel™ PCC4 Assay for Diagnosis, Prognosis and Monitoring of Prostate Cancer in Puerto Rico
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|ClinicalTrials.gov Identifier: NCT04661176|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2020
Last Update Posted : September 14, 2022
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Diagnostic Test: miR Sentinel™ PCC4 Assay|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Evaluation of the Training Plan and Impact on Acceptance of the Sentinel™ Prostate Cancer Classifier Platform (Sentinel™ PCC4 Assay) and Determination of Assay Performance Characteristics of Clinical Utility in a Puerto Rican Population|
|Actual Study Start Date :||November 30, 2020|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
- 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.
- Acceptability of the Sentinel™ PCC4 Assay for physicians assessing the prostate health in men [ Time Frame: 1 month after the intial 200 participants are accrued, and when 350 and 500 participants have been accrued. ]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.
- Validate the performance characteristics of the Sentinel™ PCC4 Assay in men in Puerto Rico [ Time Frame: 72 hours post sample receipt, urinary exosomal RNA samples will be extracted and analyzed using the Sentinel™ PCC4 Assay ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661176
|San Juan Bautista School of Medicine Clinical Research Unit|
|Caguas, Puerto Rico, 00725|
|Hospital Menonita de Caguas|
|Caguas, Puerto Rico, 00726|
|Hospital Metropolitano Dr. Pila|
|Ponce, Puerto Rico, 00717|
|Principal Investigator:||Alvin Lopez-Pujals, MD||San Juan Bautista School of Medicine Clinical Research Unit|