Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.
[BACKGROUND AND OBJECTIVE] Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use.
- 95% CI 0.69-0.75
APA
Björnebo L, Discacciati A, et al. (2025). Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.. European urology focus, 11(6), 855-862. https://doi.org/10.1016/j.euf.2025.06.008
MLA
Björnebo L, et al.. "Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.." European urology focus, vol. 11, no. 6, 2025, pp. 855-862.
PMID
40738795
Abstract
[BACKGROUND AND OBJECTIVE] Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use. Prostate-specific antigen (PSA) density (PSAD) correlates more strongly with clinically significant cancer than PSA alone. We compare outcomes using various PSAD cutoffs to select men for magnetic resonance imaging (MRI).
[METHODS] STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml. Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.
[KEY FINDINGS AND LIMITATIONS] Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml (IQR, 0.07-0.14 ng/ml). A PSAD cutoff of 0.075 ng/ml reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.
[CONCLUSIONS AND CLINICAL IMPLICATIONS] The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.
[METHODS] STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml. Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.
[KEY FINDINGS AND LIMITATIONS] Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml (IQR, 0.07-0.14 ng/ml). A PSAD cutoff of 0.075 ng/ml reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.
[CONCLUSIONS AND CLINICAL IMPLICATIONS] The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.
MeSH Terms
Aged; Humans; Male; Middle Aged; Early Detection of Cancer; Magnetic Resonance Imaging; Neoplasm Grading; Prostate; Prostate-Specific Antigen; Prostatic Neoplasms