Descriptive analysis of patients
The clinical characteristics of all patients are shown in Table 1.
"12 + X" failed to deliver sufficient detection efficiency for TZ patients.
The incidence of csPCa detected by biopsy in patients with lesions in the PZ was notably higher than that in patients with lesions in the TZ (92%, n = 121 vs. 78%, n = 83, p = 0.006) (Fig. 3a). However, there was no disparity in the incidence of csPCa determined by RP between PZ and TZ patients (97%, n = 121 VS. 95%, n = 83, p = 0.718) (Fig. 3b). Additionally, a higher incidence of RP-diagnosed csPCa compared to biopsy-detected csPCa was observed in TZ patients (95%, n = 83 vs. 78%, n = 83, p = 0.006) (Fig. 3c), while no such difference was found in PZ patients (97%, n = 121 vs. 92%, n = 121, p = 0.167) (Fig. 3d).
The detection rate of TZ csPCa using the "12 + X" approach surpassed that using "12" alone (82%, n = 79 vs. 67%, n = 79, p = 0.028) (Fig. 3e). Patients with upgraded TZ lesions exhibited a smaller tumor volume ratio compared to those without upgrading (1.26% vs. 3.35%, p = 0.027) (Fig. 3f). Moreover, the incidence of lesions was higher in the transitional zone anterior (TZa) than in the transitional zone posterior (TZp) (right 47% vs. 17%, left 52% vs. 17%, n = 83, p < 0.001) (Fig. 3g).
The construction of the "18 + X" and "18 + X" templates aimed to enhance accuracy compared with "12 + X" in detecting csPCa in the TZ.
The smaller the proportion of tumor volume, the lower the possibility of biopsy to penetrate the main pathological structure, and the more cores were required 19. The detection rate of TZ csPCa using the “12 + X” approach was higher than that using “12” alone, suggesting that the missed detection of TZ csPCa may be due to the lower distribution of “12” cores in the TZ (Fig. 3e). According to the finding that upgraded TZ patients had a smaller tumor volume ratio than the non-upgraded patients (1.26% vs. 3.35%, p = 0.027), we calculated that if upgraded patients wanted to achieve the biopsy accuracy of the non-upgraded patients, the TZ area might require 10 biopsy cores (3.35/1.26×4 ≈ 10) (Fig. 3f). Combined with the higher incidence of TZa lesions compared to TZp (Fig. 3g), we designed the “18 + X” template (Fig. 2).
Among the enrolled patients, 145 had MP-MRI lesions localized in the TZ. In TZ patients, the positive biopsy rate of “18 + X” was higher than that of “12 + X” (concurrent control: 88%, n = 145 vs. 65%, n = 51, p < 0.001, Fig. 4a; self-control: 87% vs 76%, n = 145, p = 0.016, Fig. 4b). After “12 + X” or “18 + X” PBx, 33 and 127 patients, respectively, were diagnosed with PCa by biopsy. Among them, 23 and 81 patients, respectively, were finally diagnosed with csPCa in the radical specimens. For the detection rate of csPCa in TZ patients: in the concurrent control, “18 + X” was higher than “12 + X” (83%, n = 81 vs 61%, n = 23, p = 0.026, Fig. 4c); in self-control, there was a trend of difference (83% vs. 72%, n = 81, p = 0.092, Fig. 4d). Additionally, there was no significant difference in the incidence of clinically insignificant PCa (concurrent control: 28%, n = 127 vs. 33%, n = 33, p = 0.514, Fig. 4e; self-control: 28% VS 25%, n = 127, p = 0.715, Fig. 4f) and biopsy complications (concurrent control: hematuria, 9%, n = 280 vs. 8%, n = 120, p = 0.700; fever, 1%, n = 280 vs. 2%, n = 120, p = 0.689; uroschesis, 3%, n = 280 vs. 2%, n = 120, p > 0.999, Fig. 4g) between “18 + X” and “12 + X”. The analysis results of total patients, PZ patients, and detailed self-control were shown in Supplements 1–2.
Improved "New 12” and “New 12 + X” templates showed equivalent detection rates of csPCa in TZ patients.
Based on the distribution of positive cores in TZ patient biopsies using the “18” and “18 + X” templates, we gradually refined the “New 12” and “New 12 + X” templates for TZ patients (Fig. 2). The process of refinement is illustrated in Fig. 4h and Supplement 3.
A self-control study was conducted on 145 patients with TZ lesions (81 patients with radical prostatectomy). There was no significant difference in the positive biopsy rate among the four biopsy templates of “18”, “New 12”, “18 + X”, and “New 12 + X” (83% vs. 79% vs. 87% vs. 83%, n = 145, p > 0.050), as shown in Fig. 4i. Similarly, there was no significant difference in the detection rate of csPCa among the four biopsy templates (80% vs. 80% vs. 83% VS 83%, n = 81, p > 0.050), as depicted in Fig. 4j.