Protocol Summary

Protocol No.: OCR41608

Sponsor Protocol No.: EVU-2021-001; OPTIMUM; UF-GU-006

Protocol Title.: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Principal Investigator: Brisbane, Wayne

Objective: OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Description: The purpose of the Clinical Investigation Plan and Study Protocol is to present information for the OPTIMUM clinical investigation, including the scientific basis for the study, the procedural details, the ExactVu High Resolution Micro-Ultrasound System, its safety details, and administrative details. It has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.

Phase: N/A

Age Group: Adult

Age: 18 Years - N/A

Gender: Male

Scope: National

Treatment:

Active Comparator: Micro-US Only
Subjects will undergo biopsy using micro-ultrasound only.

Active Comparator: mpMRI + Micro-US
Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

Active Comparator: mpMRI Only
Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Detailed Eligibility:

Inclusion Criteria: - Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE - No history of prior prostate biopsy - No history of genitourinary cancer, including prostate cancer - 18 years or older - No contraindications to biopsy - No contraindications to mpMRI Exclusion Criteria: - History of prior prostate biopsy - History of genitourinary cancer, including prostate cancer - Contraindications to biopsy - Contraindications to mpMRI

Applicable Conditions:

  • Prostate
  • Participation Institution:

  • No UF Health MRN : Casey Walsh
  • UF Gainesville : Casey Walsh
  • Contact:
    Casey Walsh
    Email: caseyjwh2o@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT05220501