Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

Suspended

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Diagnostic Test: TRUS biopsy

• Registration Number: NCT05064111
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	TRUS biopsy	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.

Primary Outcome Measures

Name	Time	Method
Evaluate investigational fusion software.	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.

Secondary Outcome Measures

Name	Time	Method
Assess sensitivity of software.	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.
Correlation of imaging with biomarkers.	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.
Assess accuracy of mpMRI.	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.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States