NCT05064111

Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-11-01
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2021-10-01
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study