ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

NCT04357717 | Terminated

• 1 other identifier: ECT2018-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy. Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

Conditions

Prostate Cancer

Keywords

exosome; ExoDx Prostate

Outcome Measures

Primary Outcomes (1)

• Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.

  6 months

Interventions

ExoDx Prostate DIAGNOSTIC_TEST

Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml and at least one prior negative prostate biopsy

You may qualify if:

• + years of age
• Clinical suspicion for prostate cancer
• Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
• At least one (1) prior negative prostate biopsy

You may not qualify if:

• Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
• Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
• History of prostate cancer.
• History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
• No known hepatitis status (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead

Study Sites (2)

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

New Jersey Urology

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: March 15, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

US (2)