Status:
UNKNOWN
Evaluation of the Sentinel™ PCC4 Assay for Diagnosis, Prognosis and Monitoring of Prostate Cancer in Puerto Rico
Lead Sponsor:
miR Scientific LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
22+ years
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 provide...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04661176
Start Date
November 30 2020
End Date
December 31 2024
Last Update
October 25 2023
Active Locations (3)
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1
San Juan Bautista School of Medicine Clinical Research Unit
Caguas, Puerto Rico, 00725
2
Hospital Menonita de Caguas
Caguas, Puerto Rico, 00726
3
Hospital Metropolitano Dr. Pila
Ponce, Puerto Rico, 00717