ExoDx Prostate Evaluation in Prior Negative Prostate Biop... | NCT04357717

Studies
ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

NCT04357717

Sponsor

Exosome Diagnostics, Inc.

Status

Terminated

Last Update Posted

Mar 31, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

ExoDx Prostate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

project reprioritization

Expanded Access Info

Start Date

Mar 15, 2020Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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):

Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
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.
Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ExoDx Prostate	Diagnostic Test	Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chesapeake Urology Research Associates		Baltimore	Maryland	21204	United States
New Jersey Urology

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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