ExoDx Prostate Evaluation in Active Surveillance Patient... | NCT05572099

Studies
ExoDx Prostate Evaluation in Active Surveillance Patient Population

NCT05572099

Sponsor

Exosome Diagnostics, Inc.

Status

Unknown status

Last Update Posted

Oct 7, 2022Actual

Enrollment

750Estimated

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Oct 5, 2022

First Posted Date

Oct 7, 2022Actual

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

Oct 5, 2022

Last Update Posted Date

Oct 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

Detailed Description

The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

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

Retention

Enrollment

750Estimated

Name	Type	Description	Arm Group Labels	Other Names
ExoDx Prostate	Diagnostic Test	Observational only.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Develop and evaluate risk-based scoring using the ExoDx Prostate test.		1yr after last enrolled patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Exclusion Criteria:

Clinical symptoms of urinary tract infection at time of enrollment.
History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
Known hepatitis or HIV
History of concurrent renal/bladder tumors

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Have a prostate

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sonia Kumar, PhD	Contact	6175880500		Sonia.Kumar@bio-techne.com

Overall Officials

Name	Affiliation	Role
Sonia Kumar, PhD	Exosome Diagnostics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chesapeake Urology	Recruiting	Towson	Maryland	21204	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Browse Leaves

Not provided

Browse Branches

Not provided