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Clinical Trial
. 2025 May 20;333(19):1679-1687.
doi: 10.1001/jama.2025.3579.

Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial

Adam Kinnaird  1 , Ferdinand Luger  2 , Hannes Cash  3   4 , Sangeet Ghai  5 , L Felipe Urdaneta-Salegui  6 , Christian P Pavlovich  7 , Joseph Brito  8 , Neal D Shore  9 , Julian P Struck  10 , Martin Schostak  4   11 , Niklas Harland  12 , Moisés Rodriguez-Socarrás  13 , Wayne G Brisbane  14   15 , Giovanni Lughezzani  16   17 , Harry Toledano  18 , Mohammed Salah Ouertani  19 , Petr Macek  20   21 , Christopher Fung  22 , Wendy Tu  22 , Andreas Gusenleitner  2 , Karsten Günzel  23 , Peter F Incze  24 , Arvin K George  7 , José G Pereira  6 , Robert Jansen  9 , Joseph Renzulli 2nd  8 , Laurence Klotz  25 ; OPTIMUM Investigators
Collaborators, Affiliations
Clinical Trial

Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial

Adam Kinnaird et al. JAMA. .

Abstract

Importance: High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.

Objective: To compare microultrasonography-guided and MRI fusion-guided biopsy.

Design, setting, and participants: A multicenter, international, open-label, randomized, noninferiority trial of biopsy-naive men from 20 centers (8 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and/or abnormal digital rectal examination findings) from December 2021 to September 2024.

Interventions: Participants were assigned to receive either microultrasonography-guided biopsy (n = 121), microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI; n = 226, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography; n = 331). All participants received synchronous systematic biopsy.

Main outcomes and measures: The primary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers using microultrasonography plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The secondary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers found using microultrasonography/MRI plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The noninferiority margin was set at 10%.

Results: A total of 802 men underwent randomization and 678 underwent biopsy. Median (IQR) age was 65 (59-70) years and prostate-specific antigen level was 6.9 (5.2-9.8) ng/mL; 83% self-identified as White. Gleason Grade Group 2 or higher cancer was detected in 57 participants (47.1%) in the microultrasonography group, in 141 (42.6%) in the MRI/conventional ultrasonography group, and in 106 (46.9%) in the microultrasonography/MRI group. Microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy (difference, 3.52% [95% CI, -3.95% to 10.92%]; noninferiority P < .001). Combined biopsy with microultrasonography/MRI was also noninferior to MRI/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29% [95% CI, -4.06% to 12.63%]; noninferiority P < .001). The rate of Gleason Grade Group 2 or higher cancer diagnosed by targeted biopsy only was 38.0% in the microultrasonography group, 34.1% in the MRI/conventional ultrasonography group, and 40.3% in the microultrasonography/MRI group; these differences were not significant.

Conclusions and relevance: The use of microultrasonography-guided biopsy was noninferior to MRI/conventional ultrasonography fusion-guided biopsy for the detection of Gleason Grade Group 2 or higher prostate cancer in biopsy-naive men. Microultrasonography may provide an alternative to MRI for image-guided prostate biopsy.

Trial registration: ClinicalTrials.gov Identifier: NCT05220501.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kinnaird reported receiving personal fees from Bayer and Boston Scientific outside the submitted work. Dr Ghai reported receiving personal speaker fees from Exact Imaging outside the submitted work. Dr Pavlovich reported stock options in Exact Imaging offered in recompense for consulting done more than 36 months ago. Dr Harland reported receiving personal fees from EDAP TMS and nonfinancial support from artificial neural network analysis (ANNA) of prostatic transrectal ultrasound and Endomedica outside the submitted work. Dr George reported receiving personal fees from Koelis and BK Medical outside the submitted work. Dr Jansen reported receiving personal fees from Exact Imaging for physician training/consulting outside the submitted work. Dr Renzulli reported receiving personal fees from Astellas Pharmaceutical, Intuitive Surgical, and Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Participants in the OPTIMUM Trial
aRandomization was performed using an online tool built into the electronic data capture system. No stratification or other adjustments were performed.
Figure 2.
Figure 2.. Primary and Per-Protocol Analyses of the Primary and Secondary Outcomes for the Detection of Clinically Significant Prostate Cancer
See this image and copyright information in PMC

References

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