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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- miR Scientific LLC
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Acceptability of the Sentinel™ PCC4 Assay for physicians assessing the prostate health in men
Study Overview
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.
Detailed Description
The Sentinel™ PCC4 Assay is a new molecular classification technology that provides an assessment of risk of advanced disease based on the expression of a cohort of 442 small non-coding RNAs.
At the start of the study, miR Scientific will schedule a teleconference call with all of the participating physicians in Puerto Rico (San Juan Bautista Hospital) to outline the study, the basis for the test and to explain the differences between this Sentinel™ PCC4 Assay and the calculators commonly used in risk assessment for prostate cancer (the CAPRA and/or D'Amico risk calculators and any other risk assessment methodology the uro-oncologists utilize on a routine basis).
After the clinical data (see CRF form) and Sentinel™ result have been compiled for each of the first 50 patients who meet the inclusion/exclusion criteria, the CSO and/or Medical Director of miR Scientific will chair one or more teleconference call with the participating physicians to compare the results of the Sentinel™ PCC4 Assay and the CAPRA and other risk assessment calculators, discuss the relative strengths and weaknesses of the tests and answer any questions regarding the performance of the Sentinel™ Assay and discordances (if any) between the test results. It is important to note that while the clinical data and the Sentinel Score are affiliated with specific barcodes, these data are fully anonymized and cannot be associated with specific patients. In addition to preserving the PHI confidentiality, this also ensures that the information related to the Sentinel™ PCC4 Score will not influence the current standard of care for these patients.
At the end of each session, the participating physicians will complete a questionnaire designed to evaluate the quality of the training and information related to the test result (see appendix 1). This process will be repeated for every 50 new patients enrolled for the first 200 patients and then again after the data for 350 patients becomes available. The analysis of the complete data set for the 500-patient cohort will also be presented at the completion of the study, and a final questionnaire will be administered.
To validate the performance of the miR Sentinel™ PCC4 Assay for identifying patients with prostate cancer in men with suspicion of prostate cancer for whom a core-needle biopsy is performed, the miR Sentinel™ PCC4 results with low-, intermediate- and high-risk prostate cancer (histopathological Grade Group 1, 2 or 3-5) will be compared to the results of the CAPRA score. The sensitivity, specificity, positive and negative predictive values (PPV, NPV) will be established.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported