Prostate Cancers in the Prostate-specific Antigen Interval of 1.8-3 ng/ml: Results from the Göteborg-2 Prostate Cancer Screening Trial.

BACKGROUND AND

OBJECTIVE

Magnetic resonance imaging(MRI) and targeted biopsies reduce overdiagnosis of prostate cancer(PC). It is uncertain how this strategy performs for low PSA levels. The objective was to investigate the PI-RADS distribution, frequency and characteristics of screen-detected PC with PSA of 1.8-<3ng/ml and 3-<10ng/ml.

METHODS

In the population-based Göteborg-2 screening study, 17 974 men choose to participate by having a PSA(2015-2020). One-third of the participants(n=6006) were randomized to Arm 3, men with a PSA ≥1.8ng/ml were recommended MRI. Men with positive MRI(PI-RADS3-5) had four targeted biopsies from each MRI-visible lesion. Clinically significant PC was defined as Gleason score ≥3+4.

KEY FINDINGS AND LIMITATIONS: 6006 men were included. Median age was 55.9 years. 670(11%) had PSA of 1.8-<3ng/ml(low-PSA group), median PSA 2.1ng/ml, and 377(6.3%) had PSA of 3-<10ng/ml(high-PSA group), median PSA 3.9ng/ml. PI-RADS scores of 3, 4, and 5 were observed in 7.8%, 15%, and 1.0% in the low-PSA group, and in 6.9%, 17%, and 5.3% in the high-PSA group, respectively. PC was found in 64 men (41%, 95%CI 0.33-0.49) with positive MRI findings in the low-PSA group, 33(21%) had Gleason 6 and 31(20%) had Gleason ≥7. In the high-PSA group, PC was detected in 61men (56%, 95%CI 0.46-0.66), 26(24%) had Gleason 6 and 35(32%) had Gleason ≥7. Limitations include results from only a single screening round.

CONCLUSIONS AND CLINICAL IMPLICATIONS: A non-negligible number of men with PSA 1.8-3ng/ml have clinically significant PC. Whether a delay in the diagnosis of these tumors until they reached PSA ≥3ng/ml would impair their chance of cure remains to be evaluated.