Trial results comparing ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy for Prostate Cancer were posted on 2025-11-10. The study enrolled 804 participants.
Background
Prostate cancer remains a significant health concern, and accurate diagnosis is critical for effective treatment planning. Biopsy is the definitive method for diagnosis, and advancements in imaging techniques aim to improve the precision and yield of these procedures. Multiparametric MRI (mpMRI) combined with conventional ultrasound (US) fusion biopsy has become a standard approach, allowing targeted biopsies of suspicious lesions. The emergence of ultra-high resolution micro-ultrasound offers another potential tool to enhance biopsy guidance, aiming to improve the detection of clinically significant prostate cancer (csPCa) and higher-grade cancers.
Trial design
The OPTIMUM study, a completed trial designated as Phase NA, enrolled 804 participants with Prostate Cancer. The trial was designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy. The study aimed to assess differences in the detection rates of clinically significant prostate cancer and higher-grade cancers between these two guidance methods.
Key results
The trial reported key measurements comparing the two biopsy guidance methods:
- For the outcome "Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy":
- The Microultrasonography/MRI group had 106 participants with csPCa.
- The MRI/conventional ultrasonography group had 141 participants with csPCa.
- For the outcome "Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy":
- The Microultrasonography group detected Gleason Grade Group 2 or Higher Cancers in 160 participants.
- The MRI/Conventional ultrasonography group detected Gleason Grade Group 2 or Higher Cancers in 141 participants.
A key analysis using the Jeffreys interval method reported a p-value of 0.001, indicating a statistically significant difference between the compared groups for at least one of the measured outcomes.
What this means
The results suggest that micro-ultrasound guided biopsy, either alone or in combination with MRI, may offer different detection profiles for prostate cancer compared to conventional MRI/ultrasonography fusion biopsy. Specifically, the data indicates that microUS/MRI-guided fusion biopsy detected fewer csPCa cases than MRI/conventional ultrasonography fusion biopsy, while microUS plus systematic biopsy detected more Gleason Grade Group 2 or higher cancers than mpMRI/conventional ultrasonography plus systematic biopsy. The statistically significant p-value of 0.001 highlights that these observed differences are unlikely due to chance, potentially influencing future strategies for prostate cancer diagnosis and biopsy guidance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05220501, titled "Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI", were posted on 2025-11-10 on clinicaltrials.gov.