Prostate Cancers in the Prostate-specific Antigen Interval of 1.8–3 ng/ml: Results from the Göteborg-2 Prostate Cancer Screening Trial
European Urology(2024)
Abstract
Background
Magnetic resonance imaging (MRI) and targeted biopsies reduce overdiagnosis of prostate cancer (PC). It is uncertain how this strategy performs for low prostate-specific antigen (PSA) levels.
Objective
To investigate the Prostate Imaging Reporting and Data System (PI-RADS) distribution, frequency, and characteristics of screen-detected PC with PSA of 1.8–<3 ng/ml and 3–<10 ng/ml.
Design, setting, and participants
In the population-based Göteborg-2 screening study, 17974 men choose to participate by having a PSA test (2015–2020). One-third of the participants (n = 6006) were randomized to arm 3, men with a PSA value of ≥1.8 ng/ml were recommended for MRI. Men with positive MRI (PI-RADS 3–5) had four targeted biopsies from each MRI-visible lesion.
Outcome measurements and statistical analysis
Clinically significant PC was defined as Gleason score ≥3 + 4.
Results and limitations
A total of 6006 men were included. The median age was 55.9 yr (interquartile range [IQR] 52.6–59.6). Of them, 4929 (82%) had PSA of <1.8 ng/ml, 670 (11%) had PSA of 1.8–<3 ng/ml (low-PSA group, median PSA 2.1 ng/ml [IQR 1.9–2.5]), and 377 (6.3%) had PSA of 3–<10 ng/ml (high-PSA group, median PSA 3.9 ng/ml [IQR 3.3–5.0]). PI-RADS scores of 3, 4, and 5 were observed in 7.8%, 15%, and 1.0% of men in the low-PSA group, and in 6.9%, 17%, and 5.3% of men in the high-PSA group, respectively. PC was found in 64 men (41%, 95% confidence interval [CI] 0.33–0.49) with positive MRI findings in the low-PSA group, of whom 33 (21%) had Gleason 6 (insignificant PC) and 31 (20%) had Gleason ≥7 (significant PC). In the high-PSA group, PC was detected in 61 men (56%, 95% CI 0.46–0.66), of whom 26 (24%) had Gleason 6 (insignificant PC) and 35 (32%) had Gleason ≥7 (significant PC). Limitations include results from only a single screening round.
Conclusions
A non-negligible number of men with PSA 1.8–3 ng/ml have clinically significant PC. Whether a delay in the diagnosis of these tumors until they reached PSA ≥3 ng/ml would impair their chance of cure remains to be evaluated.
Patient summary
We studied screening using prostate-specific antigen (PSA) and magnetic resonance imaging in men with PSA 1.8–3 ng/ml. We found a non-negligible number of potentially harmful prostate cancers in these men.
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Key words
Prostate cancer,Prostate-specific antigen,Magnetic resonance imaging,Screening
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