ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

NCT ID: NCT04357717

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2021-09-01

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.

Detailed Description

Primary Endpoint:

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

Secondary Endpoints (exploratory):

1. Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.

2. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).

3. Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.

4. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ExoDx Prostate

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 50+ 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Exosome Diagnostics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

New Jersey Urology

Voorhees Township, New Jersey, United States

Countries

United States

Other Identifiers

ECT2018-001

Identifier Type: -

Identifier Source: org_study_id