Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

University of Arizona

Status: Suspended

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Diagnostic Test: TRUS biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05064111

2012285076

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

All subjects

Description:

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.

Treatment:

Diagnostic Test: TRUS biopsy