Comparison of transperineal and transrectal prostate biopsy in the outpatient setting: a randomized controlled trial

Objective: to compare transperineal (TP) versus transrectal (TR) prostate biopsy under local anesthesia in terms of diagnostic yield, safety, and patient tolerability in an outpatient randomized trial.
Material and Methods. A total of 106 men with suspected prostate cancer were randomized 1:1 to TP (n=54) or TR (n=52) biopsy. All patients underwent 12-core systematic sampling; MRI-targeted cores were added for PI-RADS ≥3. Antibiotic prophylaxis was given only in the TR group. The primary endpoint was detection of clinically signifcant prostate cancer (csPCa, ISUP ≥2). Secondary outcomes included overall cancer detection, complications (Clavien–Dindo), pain scores (VAS), procedure time, and satisfaction.
Results. Cancer was detected in 74.1 % of TP vs 55.8 % of TR patients (p=0.066). csPCa was found in 44.4 % vs 34.6 % (p=0.33). Infectious complications occurred only after TR biopsy (11.5 % vs 0 %; p=0.012). No severe (grade III–V) events were observed. Minor events (hematuria, hematospermia) occurred in 30 % of both groups. Median VAS pain was lower in TP (3 vs 5, p<0.01); severe pain (VAS ≥6) was reported by 6 % in TP vs 33 % in TR. Median procedure time was longer with TP (20 vs 8 min, p<0.001). Patient satisfaction was high in both arms (85 % vs 75 %, p=0.20).
Conclusion. Outpatient TP biopsy provided equivalent diagnostic performance to TR, with markedly fewer infectious complications and lower pain scores. Despite longer procedure time, satisfaction remained high. These fndings support TP biopsy as a safer alternative to TR in routine practice.

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