This randomized community-based study evaluated whether a prostate cancer screening model that combines serum total prostate-specific antigen (tPSA) with biparametric magnetic resonance imaging (bpMRI) is feasible and clinically valuable in a Chinese population. The primary aim was to compare detection of clinically significant prostate cancer (csPCa) between a precision screening strategy using tPSA plus bpMRI and a standard screening pathway based on tPSA-guided systematic biopsy.
Between May 2024 and May 2025, investigators enrolled 2,251 men aged 50 years or older from three community health service centers in Beijing. Participants were randomized in a 2:1 ratio to a precision screening group (n = 985) or a standard screening group (n = 1,266). The cohort’s median age was 68 years (range 57–90 years). The study recorded the numbers recommended for biopsy, numbers who actually underwent biopsy, biopsy positivity rates, and concordance between biopsy and post-operative Gleason scores. The primary outcome measure was the csPCa detection rate; intergroup comparisons were performed as reported in the abstract.
In the precision screening group, men with tPSA ≥4 μg/L underwent bpMRI. Management after imaging was protocolized: those with a prostate imaging reporting and data system (PI-RADS) score ≥3 were recommended to receive systematic combined with targeted biopsy; those with tPSA ≥10 μg/L and PI-RADS <3 were recommended to undergo systematic biopsy alone.
In the standard screening group, men with tPSA ≥4 μg/L were recommended to undergo systematic biopsy without prebiopsy MRI.
The protocol distinguished between recommended biopsy rates based on screening pathway and imaging findings. The study recorded both the recommended biopsy rates and the number of participants who actually underwent biopsy in each arm, allowing comparison of real-world uptake and diagnostic yield between precision and standard approaches.
Primary outcome: detection rate of csPCa. Secondary process and diagnostic outcomes included recommended biopsy rate, actual biopsy uptake, overall positive biopsy rate, distribution of tumor stage at diagnosis, and concordance between biopsy Gleason score and post-operative pathology for patients undergoing radical prostatectomy. The English abstract reports use of the Mann-Whitney U test for intergroup comparisons; the Chinese abstract reports chi-square testing for the primary outcome comparisons. Reported P values for key comparisons are provided where available in the source.
In the precision screening group (n = 985): 115 (11.7%) participants had tPSA ≥4 μg/L, and 30 underwent bpMRI. The recommended biopsy rate in this group was 2.9% (29/985), and 20 participants actually underwent prostate biopsy. Among those biopsied, 15 prostate cancer cases were detected: 14 met criteria for csPCa and 1 was clinically insignificant.
In the standard screening group (n = 1,266): 111 (8.8%) participants had tPSA ≥4 μg/L, yielding a recommended biopsy rate of 8.8% (111/1,266). Twenty-six participants underwent systematic biopsy, and 14 prostate cancer cases were detected, comprising 7 csPCa and 7 clinically insignificant cancers.
Overall positive biopsy rate was 75.0% in the precision screening group versus 58.3% in the standard group; this difference did not reach statistical significance (P = 0.141). The csPCa detection rate was substantially higher in the precision screening group: 70.0% versus 26.9% in the standard group, a statistically significant difference (P = 0.004).
Across the 29 patients diagnosed with prostate cancer in the trial, staging distribution was reported as 17 (58.6%) localized disease, 10 (34.5%) locally advanced disease, and 2 (6.9%) metastatic disease. Twenty-one patients went on to radical surgery; among these, concordance between biopsy and post-operative pathological Gleason scores was 70.0% in the precision screening group and 36.4% in the standard screening group. The difference in concordance rates did not reach statistical significance (P = 0.198) according to the source.
Within this community-based randomized cohort, a screening approach that triaged men with tPSA ≥4 μg/L to bpMRI and then to targeted plus systematic biopsy when PI-RADS ≥3, or to systematic biopsy when tPSA ≥10 μg/L with low PI-RADS, proved feasible. It was associated with a lower recommended biopsy rate and fewer biopsies performed overall compared with the standard tPSA-only screening pathway, while achieving a significantly higher csPCa detection rate. The precision pathway also showed higher biopsy-to-surgical Gleason concordance numerically, though this did not meet statistical significance in the reported sample. The authors conclude the combined tPSA plus bpMRI model can reduce unnecessary biopsies, optimize screening resource allocation, and serve as a basis for precision screening strategies in similar settings.
All authors declared no conflicts of interest. Keywords listed in the source include Biparametric magnetic resonance imaging; Prostate cancer; Prostate-specific antigen; Screening.