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Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

About

Brief Summary

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.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

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
  • No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study

Exclusion Criteria:

  • History of prior prostate biopsy
  • History of genitourinary cancer, including prostate cancer
  • Contraindications to biopsy
  • Contraindications to mpMRI

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Study Stats
Protocol No.
23-000511
Category
Prostate Cancer
Contact
Ankush Sachdeva
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05220501
For detailed technical eligibility, visit ClinicalTrials.gov.