Oncology · Medical Literature
[Feasibility and clinical value of a prostate cancer screening model based on biparametric magnetic resonance imaging combined with prostate-specific antigen in a Chinese population].
Abstract
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. 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. 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). 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.
Clinical relevance
This study addresses the critical gap in optimizing prostate cancer screening strategies for Chinese men by evaluating a precision model that integrates serum tPSA with biparametric MRI (bpMRI), thereby avoiding the reliance on full multiparametric MRI or systematic biopsy alone. The enrolled population — community-dwelling Chinese men aged ≥50 years — represents a large and underserved screening demographic where resource allocation and overdiagnosis of clinically insignificant disease remain major concerns. Given rising prostate cancer incidence in China and the known limitations of PSA-only screening, this work is timely and directly relevant to urologists and oncologists designing population-level screening protocols.
Key findings
1. The precision screening group (bpMRI-augmented, n=985) achieved a clinically significant prostate cancer (csPCa) detection rate of 70.0% (14/20 biopsied), compared to 26.9% (7/26 biopsied) in the standard screening group (PSA-only referral, n=1,266); this difference was statistically significant (P=0.004). 2. The recommended biopsy rate was markedly lower in the precision screening group at 2.9% (29/985) versus 8.8% (111/1,266) in the standard group, representing a ~67% relative reduction in unnecessary biopsy referrals. 3. The overall biopsy positivity rate was 75.0% in the precision screening group versus 58.3% in the standard group, though this difference did not reach statistical significance (P=0.141). 4. Among all 29 diagnosed prostate cancer patients across both groups, 58.6% (17/29) had localized disease, 34.5% (10/29) had locally advanced disease, and 6.9% (2/29) had metastatic disease, indicating a spectrum of disease stage at community-level detection. 5. Gleason score concordance between biopsy and post-operative pathology was 70.0% in the precision screening group versus 36.4% in the standard screening group among 21 surgical patients, though this difference was not statistically significant (P=0.198). 6. Among precision screening group participants with tPSA ≥4 µg/L, only 30 underwent bpMRI, of whom those with PI-RADS ≥3 were directed to systematic plus targeted biopsy, while those with tPSA ≥10 µg/L and PI-RADS <3 underwent systematic biopsy alone, demonstrating a tiered, risk-stratified referral pathway.
Practice implications
Clinicians screening men aged ≥50 years for prostate cancer should consider implementing a tiered tPSA + bpMRI pathway: refer men with tPSA ≥4 µg/L for bpMRI, restrict combined systematic plus targeted biopsy to those with PI-RADS ≥3, and reserve systematic biopsy alone for high-PSA (≥10 µg/L) cases with PI-RADS <2, thereby substantially reducing unnecessary procedures while significantly enriching csPCa yield. The nearly three-fold higher csPCa detection rate in the precision arm (70.0% vs. 26.9%, P=0.004) supports prioritizing bpMRI-guided workflows over PSA-threshold-only referral in resource-conscious community screening programs. The improved Gleason concordance trend in the precision group (70.0% vs. 36.4%) further suggests that bpMRI-guided targeting may enhance pre-operative risk stratification, with implications for treatment selection and surgical planning, though larger studies are needed to confirm significance.