Clinical trial · Interventional
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: A 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men With Clinical Suspicion of Prostate Cancer.
NCT05220501CI-TRIAL-00097081OPTIMUMcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microultrasonography Targeted Biopsy | Diagnostic Test | — | UNRESOLVED |
| MRI Targeted Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Microultrasonography only
- description
- Subjects will undergo biopsy using micro-ultrasound only.
- interventionNames
- Diagnostic Test: Microultrasonography Targeted Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Microultrasonography + MRI
- description
- Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
- interventionNames
- Diagnostic Test: Microultrasonography Targeted Biopsy
- Diagnostic Test: MRI Targeted Biopsy
- type
- ACTIVE_COMPARATOR
- label
- MRI + Conventional Ultrasonography
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKinnaird A, Luger F, Cash H, Ghai S, Urdaneta-Salegui LF, Pavlovich CP, Brito J, Shore ND, Struck JP, Schostak M, Harland N, Rodriguez-Socarras M, Brisbane WG, Lughezzani G, Toledano H, Ouertani MS, Macek P, Fung C, Tu W, Gusenleitner A, Gunzel K, Incze PF, George AK, Pereira JG, Jansen R, Renzulli J 2nd, Klotz L; OPTIMUM Investigators. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. 2025 May 20;333(19):1679-1687. doi: 10.1001/jama.2025.3579. PMID 40121537