Population-based randomized trial of screening for clinically significant prostate cancer ProScreen: A pilot study Journal Article


Authors: Rannikko, A.; Leht, M.; Mirtti, T.; Kenttämies, A.; Tolonen, T.; Rinta-Kiikka, I.; Kilpeläinen, T. P.; Natunen, K.; Lilja, H.; Lehtimäki, T.; Raitanen, J.; Kujala, P.; Ronkainen, J.; Matikainen, M.; Petas, A.; Taari, K.; Tammela, T.; Auvinen, A.
Article Title: Population-based randomized trial of screening for clinically significant prostate cancer ProScreen: A pilot study
Abstract: Objectives: To evaluate the feasibility of a population-based screening trial using prostate-specific antigen (PSA), a kallikrein panel and multiparametric magnetic resonance imaging (MRI) aimed at minimizing 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 was identified from the population registry and invited for screening with three stepwise tests (PSA, kallikrein panel and MRI). Men with PSA levels ≥3 ng/mL were further tested with the kallikrein panel, and those with positive findings (risk >7.5%) were referred for prostate MRI. Men with positive MRI (Prostate Imaging Reporting and Data System [PI-RADS] 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 levels ≥3 ng/mL (7% of the invited and 17% of the participants). Of these, 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 [kallikrein panel]-positive) had a suspicious MRI finding (PI-RADS score ≥3) and five were diagnosed with a clinically significant prostate cancer (Gleason Grade Group [GG] ≥2) at fusion biopsy (3% of the participants), with two GG 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 suboptimal. © 2021 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.
Keywords: prostate cancer; prostate-specific antigen; screening; randomized trial; 4-kallikrein panel; targeted biopsy; multiparametric mri; #pcsm; #prostatecancer; #uroonc
Journal Title: BJU International
Volume: 130
Issue: 2
ISSN: 1464-4096
Publisher: Wiley Blackwell  
Date Published: 2022-08-01
Start Page: 193
End Page: 199
Language: English
DOI: 10.1111/bju.15683
PUBMED: 34958531
PROVIDER: scopus
PMCID: PMC9327584
DOI/URL:
Notes: Article -- Export Date: 1 August 2022 -- Source: Scopus
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  1. Hans Gosta Lilja
    345 Lilja