This single-center, retrospective comparative study evaluated whether targeted biopsy (TB) alone achieves similar diagnostic performance to combined targeted plus systematic biopsy (SB) in patients with prostate lesions scored PI-RADS v2.1 category 4–5 on pre-biopsy biparametric MRI. Clinical data were collected from March 2018 to December 2023.
A total of 1,060 consecutive patients who underwent combined TB and SB at the authors' institution were included. All patients had pre-biopsy biparametric magnetic resonance imaging with lesions assigned PI-RADS v2.1 category 4 or 5. The cohort constituted the population used to compare detection rates between biopsy strategies.
Two diagnostic approaches were compared: 1) performing targeted biopsy alone of MRI-identified lesions; and 2) performing combined targeted biopsy plus systematic biopsy. Although all patients in the cohort had received combined TB+SB clinically, the study compared the diagnostic yield of TB alone versus the combined approach using the same dataset.
Using the full cohort (n = 1,060), detection rates for prostate cancer (PCa) and clinically significant prostate cancer (csPCa) were reported for each strategy.
TB alone detected PCa in 79.6% (844/1,060) of patients and csPCa in 67.9% (720/1,060).
Combined TB+SB detected PCa in 82.2% (871/1,060) of patients and csPCa in 69.7% (739/1,060).
Statistical testing showed no significant difference between the two strategies for PCa detection (P = 0.136) or csPCa detection (P = 0.373). Measures of agreement indicated substantial concordance between TB alone and the combined approach (Kappa = 0.918 for PCa and Kappa = 0.958 for csPCa; both P < 0.001).
The authors performed stratified analyses by PI-RADS category to assess whether agreement persisted within PI-RADS 4 and PI-RADS 5 subgroups.
Among patients with PI-RADS 4 lesions (n = 667), csPCa detection was 59.2% (395/667) with TB alone and 61.5% (410/667) with combined TB+SB. Agreement was high (Kappa = 0.953, P < 0.001).
Among patients with PI-RADS 5 lesions (n = 393), csPCa detection was 82.7% (325/393) with TB alone and 83.7% (329/393) with combined TB+SB. Agreement again was high (Kappa = 0.964, P < 0.001).
These subgroup results indicate that the close diagnostic correspondence between TB alone and combined biopsy held across both PI-RADS 4 and PI-RADS 5 lesions in this cohort.
A subset of 730 patients who underwent radical prostatectomy provided postoperative pathological findings used as the reference standard for assessing pathological upgrading.
Overall pathological upgrading rates were reported as 30.5% (223/730) for TB alone and 25.9% (189/730) for the combined biopsy strategy.
Upgrading specifically from biopsy-negative or clinically insignificant prostate cancer on biopsy to clinically significant prostate cancer on postoperative pathology occurred in 12.3% (90/730) after TB alone and in 9.9% (72/730) after combined TB+SB.
These comparisons against long-term surgical pathology suggest a modest reduction in upgrading when systematic sampling is added, although the study emphasizes comparable detection rates at the time of biopsy.
Across the full cohort and subgroups, comparisons between TB alone and combined TB+SB demonstrated no statistically significant differences in detection of PCa or csPCa. High Kappa values in the overall cohort and in PI-RADS 4 and 5 subgroups indicate substantial to near‑perfect agreement (all reported P values < 0.001 for agreement measures).
The investigators conclude that in patients with PI-RADS 4–5 lesions on biparametric MRI, targeted biopsy alone may provide diagnostic performance comparable to combined targeted plus systematic biopsy. They state that adopting TB alone in this population could reduce procedural burden for patients and conserve healthcare resources while maintaining diagnostic efficacy.
All authors declared no competing interests. The abstract provides numerical results for detection rates, agreement statistics, and upgrading rates. Detailed procedural specifics, complication rates, or additional limitations beyond what appears in the abstract were not reported in the PubMed abstract; full-text details would be required to evaluate technique, operator experience, or other potential confounders.
For patients with MRI-visible PI-RADS 4–5 lesions, TB alone detected the majority of PCa and csPCa cases and demonstrated high concordance with combined TB+SB in this retrospective series of 1,060 patients.
When postoperative pathology in 730 radical prostatectomy specimens was used as the reference, combined biopsy showed a lower pathological upgrading rate than TB alone, but both approaches missed or under-graded a fraction of csPCa.
The authors propose that TB alone could be a clinically equivalent, less burdensome alternative to combined biopsy in the specified MRI-positive population; further details and prospective validation would be needed to inform changes to practice.