Frozen section analysis assisted MRI targeted prostate biopsy - results of the randomized clinical FAST trial
In brief
Frozen sections cut prostate biopsy cores from 15 to 3, with similar detection
In 160 men with suspicious MRI lesions, frozen-section review of targeted cores let clinicians skip systematic sampling when cancer was found: clinically significant cancer detection was 97% versus 93% with standard biopsy, while median cores fell from 15 to 3. Patients also reported less pain and bleeding. This small trial supports fewer cores without reduced detection in this selected group, but broader confirmation is needed.
- Journal
- European journal of cancer (Oxford, England : 1990) (Q1)
- Published
- 8 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Matthias Jahnen, Kristina Schwamborn, Andreas Sauter, Phillip Korn, Flemming Lischweski, Ludwig Pachmayr, et al.
- PMID
- 42858622
- DOI
- 10.1016/j.ejca.2026.117772
Why clinicians should know about it
- Picked for Radiology, Radiation Oncology, Nuclear Medicine, Medical Physics and Imaging (paper of the day, 12 October 2026): FSA‑guided prostate biopsy non‑inferiority trial
- Picked for Pathology and Forensic Medicine (paper of the day, 12 October 2026): Frozen section guides targeted biopsy, pathology central
- Picked for Urology (paper of the day, 12 October 2026): Non‑inferior MRI‑targeted biopsy, reduces cores
Abstract
PURPOSE: Multiparametric magnetic resonance imaging (mpMRI) targeted prostate biopsy is still commonly combined with systematic biopsy, resulting in a high number of extracted biopsy cores. This study evaluated whether a frozen section analysis (FSA) guided biopsy strategy enabling immediate assessment of targeted biopsy and omitting systematic biopsy in case of clinically significant prostate cancer (csPCa) is non-inferior to standard combined biopsy while substantially reducing the number of biopsy cores. MATERIAL AND METHODS: In this prospective randomized trial, men with PI-RADS ≥ 4 lesions were randomized to standard combined biopsy (Arm A) or FSA guided primarily MRI-targeted biopsy (Arm B). In Arm B, three targeted cores were obtained, with two immediately analyzed by FSA. Additional systematic biopsy was performed only if FSA was negative or inconclusive. The primary endpoint was detection of csPCa (ISUP grade group ≥2). A non-inferiority margin of -10 %age points was prespecified. RESULTS: A total of 160 patients were randomized (Arm A: 80, Arm B: 80). csPCa detection rates were 93% in Arm A and 97% in Arm B, yielding a risk difference of 5.0% (95% CI -5.2-14.7), meeting non-inferiority criteria. The median number of biopsy cores was reduced from 15 to 3 in Arm B (p < 0.001). Pain, discomfort, macrohematuria, and hematospermia were significantly lower in the experimental arm (all p < 0.05). CONCLUSIONS: FSA guided prostate biopsy enabling immediate assessment of targeted biopsy cores is safe, minimally invasive, and non-inferior regarding the detection of csPCa to standard biopsy in men with suspicious mpMRI lesions. This approach substantially reduces biopsy cores and patient burden by omitting systematic biopsy in case of positive FSA while maintaining oncological safety.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.