Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

November 25, 2025 updated by: University of Arizona

Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique

The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.

Description

Inclusion Criteria:

  1. Able to give informed consent
  2. Male - age > 18
  3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa)
  4. Scheduled for TRUS biopsy for prostate lesion or mass

Exclusion Criteria:

  1. Age under 18 years of age.
  2. Female
  3. Pre-existing blood dyscrasias
  4. Inability to perform TRUS due to anal sphincter closure/surgery
  5. Patients needing general anesthesia
  6. Patients allergic to lidocaine
  7. Patients allergic or unable to take antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All subjects
The experimental conditions will include a standard prostate biopsy using an FDA-approved ultrasound machine with application of the experimental (non-FDA approved) image fusion software.
Diagnostic test: TRUS biopsy
The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate investigational fusion software.
Time Frame: Through study completion, planned 5 year duration.
To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI.
Through study completion, planned 5 year duration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess accuracy of mpMRI.
Time Frame: Through study completion, planned 5 year duration.
To assess the diagnostic accuracy of Multiparametric Magnetic Resonance Imaging (mpMRI) provided Prostate Imaging Reporting and Data System (PIRADS) with pathology as the reference standard. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images.
Through study completion, planned 5 year duration.
Assess sensitivity of software.
Time Frame: Through study completion, planned 5 year duration.
To assess the sensitivity of the investigation software in successfully targeting clinically significant prostate cancer, defined as Gleason score of 3+4 or greater. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images.
Through study completion, planned 5 year duration.
Correlation of imaging with biomarkers.
Time Frame: Through study completion, planned 5 year duration.
To correlate Prostate Imaging Reporting and Data System (PIRADS) score from Multiparametric Magnetic Resonance Imaging (mpMRI) with cellular/ molecular biomarkers of aggressive cancer in the biopsy tissue samples. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images.
Through study completion, planned 5 year duration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Hina Arif-Tiwari, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012285076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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