N/A Completed N=802 Randomized Diagnostic

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Prostate Cancer

Source: ClinicalTrials.gov NCT05220501 ↗

Enrolled (actual)

802

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcomePrimary: Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy — 160; 141 Participants — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy	160; 141	<0.001 sig
SECONDARY Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy	106; 141	—

Eligibility Criteria

Inclusion Criteria

Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05220501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.