MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy (OU-SCC-PROBX)

University of Oklahoma (OU)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Standard of Care Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05471128

IRG-19-142-01 (Other Grant/Funding Number)

OU-SCC-PROBX

Details and patient eligibility

About

The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

Full description

This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.

Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients scheduled to undergo biopsy and with one of the following:

   • Men with suspicion of prostate cancer
   • Men on active surveillance

2. Age ≥18 [30]

3. Have available multiparametric prostate MRI

4. Able to provide written, informed consent

5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures

6. Be willing and able to comply with scheduled visits

Exclusion criteria

1. Previously confirmed prostate cancer diagnosis with Grade Group >= 2
2. Unable to undergo prostate biopsy
3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
4. Men with contraindication for MRI or a prostate biopsy
5. Prostate biopsy within 8 weeks prior to mpMRI.
6. Any history of prostate treatment