Abstract:

Objective: To evaluate the feasibility and clinical value of a prostate cancer screening model incorporating total prostate-specific antigen (tPSA) and biparametric magnetic resonance imaging (bpMRI) in a Chinese population. Methods: Between May 2024 and May 2025, 2 251 men aged 50 years or older from three community health service centers in Beijing were enrolled, who were randomly assigned to the precise screening group and the standard screening group in a 2 ∶ 1 ratio in the community health service centers. In the precision screening group, participants with tPSA≥4 μg/L underwent bpMRI; those with a prostate imaging reporting and data system (PI-RADS) score≥3 were recommended to undergo systematic combined with targeted biopsy, while those with tPSA≥10 μg/L and PI-RADS < 3 were recommended to undergo systematic biopsy alone. In the standard screening group, participants with tPSA≥4 μg/L were recommended to undergo systematic biopsy. The number of participants who actually underwent biopsy, biopsy positivity rate, and Gleason score concordance rate was recorded. The primary outcome measure was the detection rate of clinically significant prostate cancer (csPCa), and the intergroup comparisons were performed using the Mann-Whitney U test. Results: A total of 2 251 men were included in the analysis, with a median age of 68 years (range: 57-90 years). In the precision screening group (n=985), 115 (11.7%) participants had tPSA≥4 μg/L, of whom 30 underwent bpMRI. The recommended biopsy rate was 2.9% (29/985), and 20 participants actually underwent prostate biopsy. A total of 15 prostate cancer cases were detected, including 14 csPCa and one clinically insignificant prostate cancer. In the standard screening group (n=1 266), 111 (8.8%) participants had tPSA ≥4 μg/L, with a recommended biopsy rate of 8.8% (111/1 266); 26 of them underwent systematic biopsy, and 14 prostate cancer cases were detected, including 7 csPCa and 7 clinically insignificant prostate cancer. The overall positive biopsy rate in the precision screening group was 75.0%, which was not statistically significant compared with that in the standard screening group (58.3%, P=0.141). However, the csPCa detection rate in the precision screening group reached 70.0%, which was significantly higher than that in the standard screening group (26.9%), and the difference was statistically significant (P=0.004). Among the 29 diagnosed prostate cancer patients, 17 (58.6%) had localized disease, 10 (34.5%) had locally advanced disease, and 2 (6.9%) had metastatic disease. Among the 21 patients who underwent radical surgery, the concordance rate between biopsy and post-operative pathological Gleason scores was 70.0% in the precision screening group, higher than that in the standard screening group (36.4%), although the difference was not statistically significant (P=0.198). Conclusion: The prostate cancer screening model based on serum tPSA combined with bpMRI demonstrates good feasibility, reduces unnecessary biopsies, optimizes the allocation of screening resources, and provides a basis for precision screening strategies.

Key words: Prostate cancer, Biparametric magnetic resonance imaging, Screening, Prostate-specific antigen