Introduction

Despite the unequivocal contribution of targeted MRI fusion biopsy, it is known that ultrasound-guided biopsy with systematic sampling still is the main tool for prostate cancer (PC) diagnosis in developing countries. However, the number of sampled fragments remains a matter of controversy. Our objective was to compare the cancer detection rate (CDR) and the complications of 12 versus 20-core ultrasound guided transrectal prostate biopsy.

Methods

A prospective controlled study was conducted enrolling 758 consecutive patients who underwent biopsy with 1:1 randomization ratio for 12-core versus 20-core biopsy under periprostatic block local anesthesia. 76 patients were on active surveillance and 284 had at least one previous biopsy. The overall and the significant (Gleason ≥7) CDR were compared between the 2 techniques. We also evaluated the CDR according to PSA, free PSA, PSA density, prostate volume, previous biopsy and suspicious digital rectal examination. We assessed the occurrence of complications and the pain immediately after the procedure using the visual analogue pain intensity scale.

Results

The CDR was 47.7% and 37.7% in 20-core and 12-core groups, respectively (OR 1.510; 95% CI: 1.130 to 2.018, p=0.0052). An overall 18.5% significant increase in Gleason score ≥7 detection rate was found in the 20-core group (83.7 vs. 65.2% p=0.0463). The CDR was also in favor of the 20-core when the active surveillance patients were excluded 45.6% and 32.9% (OR 1.712; CI 95% 1.215 to 2.412 p=0.002). Considering only the surveillance patients the 20-core protocol also showed higher CDR 66.7 vs. 52.5% (p=0,209). The CDR between the two techniques were similar according to PSA levels (p=0.874), prostate volume p=0.619), previous biopsy (p=0.5973), age (p=0.070), suspicious DRE (p=0.146), free-to-total (p=0.542) and PSA density (p=0.585).The occurrence of any complication and acute prostatitis were similar between the 20- and 12- core groups: 10.7 vs. 10.4% (p=0.899) and 6.5 vs. 4.2% (p=0.2166), respectively. The mean visual analogue pain intensity scale were also similar in 20-core when compared to 12-core group 2.35 vs. 2.19 (p=0.7977).

Conclusions

Our randomized trial revealed that the overall cancer positivity and the diagnosis of aggressive tumors were significantly higher in the 20-core prostate biopsy when compared to the 12-core protocol. The complication rates and the pain experienced by the patients were similar in both groups. _x000D_ _x000D_ ClinicalTrials.gov NCT02825225

Funding

None