Safety and Diagnostic Performance of a Novel Prostate Biopsy Technique Using MRI Fused Cone-Beam CT

Purpose: To evaluate the safety profile and diagnostic performance of a novel MRI-fused CBCT-guided transgluteal prostate biopsy technique.

Materials and Methods: A retrospective chart review was performed of patients who underwent MRI-fused CBCT-guided prostate biopsy at a single academic center between September 2019 and October 2024. Eligible patients had prostate lesions scored as PI-RADS 3 or greater on MRI with clinical suspicion for prostate cancer. Patient demographics, comorbidities, prostate-specific antigen (PSA) levels, biopsy outcomes, complications, and treatment decisions were recorded. Descriptive statistics were calculated, and Spearman’s rank correlation was used to assess the relationship between PI-RADS and Gleason scores.

Results: A total of 139 patients underwent 161 procedures. The mean age was 68.0 ± 7.1 years, and mean PSA was 10.7 ± 7.2 ng/ml. Most patients (80.7%) had at least one prior biopsy. Partial or complete inconclusive results occurred in 16 procedures (9.9%). Clinically significant cancers (Gleason ≥7) were more frequently identified in PI-RADS 5 lesions. Spearman correlation demonstrated a statistically significant weakly positive association between PI-RADS and Gleason scores (ρ = 0.3, p < 0.001). The overall complication rate was 2.5%, including two cases of sepsis, one urinary tract infection, and one episode of gross hematuria with urinary retention. Mild hematuria occurred in 9.3% of patients and resolved spontaneously prior to same-day discharge.

Conclusion: MRI-fused CBCT-guided transgluteal biopsy demonstrates a favorable safety profile and diagnostic performance, supporting its potential as a reliable alternative to traditional prostate biopsy methods.