Objectives

To evaluate feasibility of a population-based screening trial using prostate-specific antigen (PSA), a kallikrein panel and multiparametric magnetic resonance imaging (MRI) aimed at minimising overdiagnosis, while retaining mortality benefit.

Patients and Methods

Feasibility of the screening algorithm was evaluated in terms of participation, screening test results and cancer detection. A random sample of 400 men aged 65 years were identified from population registry and invited for screening with three stepwise tests (PSA, kallikrein panel and MRI). Men with PSA ≥3 ng/ml were further tested with kallikrein panel, and those with positive finding (risk>7.5%) were referred for prostate MRI. Men with positive MRI (PIRADS score 3-5) had targeted biopsies only. Men with negative MRI, but PSA density ≥0.15 underwent systematic biopsies.

Results

Of the 399 men invited, 158 (40%) participated and 27 had PSA ≥3 ng/ml (7% of the invited and 17% of the participants). Of them, 22 had a positive kallikrein panel (6% of the invited and 81% of the PSA-positive men). Finally, 10 men (3% of the invited and 45% of 4Kscore-positive) had a suspicious MRI finding (PI-RADS score ≥3) and five were diagnosed with a clinically significant prostate cancer (PCa) (Gleason Grade Group GGG≥2) at fusion biopsy (3% of the participants), with two GGG 1 cases (1%). Additional testing (kallikrein panel and MRI) after PSA reduced biopsies by 56%.

Conclusion

The findings constitute proof of principle for our screening protocol, as we achieved a substantial detection rate for clinically significant cancer with few clinically insignificant cases. Participation, however, was sub-optimal.