ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Sc... | NCT03597386

Studies
ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy

NCT03597386

Sponsor

University of Rochester

Status

Withdrawn

Last Update Posted

Mar 1, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostate Disease

Interventions

Not provided

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study will not be conducted

Expanded Access Info

Start Date

Jan 23, 2019Actual

Primary Completion Date

Jan 24, 2019Actual

Completion Date

Jan 24, 2019Actual

First Submitted Date

Jul 13, 2018

First Submission Date that Met QC Criteria

Jul 13, 2018

First Posted Date

Jul 24, 2018Actual

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

Feb 27, 2019

Last Update Posted Date

Mar 1, 2019Actual

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 purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.

Detailed Description

Not provided

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

0Actual

Label	Type	Description	Intervention Names
All Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy		baseline

Secondary Outcomes

Measure	Description	Time Frame
Correlation of PIRADS scores with ConfirmMDx testing outcomes		baseline
Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes		baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prior documented elevated PSA (> 4.0 ng/ml)
MRI lesion based on PIRADS scoring within the past 3 years
Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed.
May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy
Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy
Ability to give informed consent

Exclusion Criteria:

Any metastatic cancer
Any prostate cancer
Active infection: urinary tract infection or prostate infection precluding prostate biopsy
Anal stenosis or severe anal disease preventing prostate biopsy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only men are eligible for this prostate study

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects were selected due to increased risk of prostate cancer with prior elevated prostate specific antigen (PSA), mpMRI, prostatic lesions and negative MRI-ultrasound guided fusion biopsy due to the potential for prostate cancer that was not detected prior.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center		Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011469	Prostatic Diseases

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided