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

NCT03597386 | Withdrawn

• 1 other identifier: 71689
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Disease

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Correlation of PIRADS scores with ConfirmMDx testing outcomes

  baseline

• Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes

  baseline

• Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy

  baseline

Study Arms (1)

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only men are eligible for this prostate study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

MR/US prostate fusion biopsy

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Urology

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: January 23, 2019
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)