Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

NCT05064111 | Suspended FDA Device

• 1 other identifier: 2012285076
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate investigational fusion software.

  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 Outcomes (3)

• Assess accuracy of mpMRI.

  Through study completion, planned 5 year duration.

• Assess sensitivity of software.

  Through study completion, planned 5 year duration.

• Correlation of imaging with biomarkers.

  Through study completion, planned 5 year duration.

Study Arms (1)

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

Interventions

TRUS biopsy DIAGNOSTIC_TEST

The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.

All subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hina Arif-Tiwari, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: October 1, 2021
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)