ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

Prostate Cancer Clinical Trial

Official title:

Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04357717
• Other study ID #: ECT2018-001
• Status: Terminated
• Start date: March 15, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Exosome Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• ExoDx Prostate
Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

Locations

Country	Name	City	State
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	New Jersey Urology	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Exosome Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.		6 months