TY - JOUR
T1 - Population-based randomized trial of screening for clinically significant prostate cancer ProScreen
T2 - a pilot study
AU - Rannikko, Antti
AU - Leht, Mare
AU - Mirtti, Tuomas
AU - Kenttämies, Anu
AU - Tolonen, Teemu
AU - Rinta-Kiikka, Irina
AU - Kilpeläinen, Tuomas P.
AU - Natunen, Kari
AU - Lilja, Hans
AU - Lehtimäki, Terho
AU - Raitanen, Jani
AU - Kujala, Paula
AU - Ronkainen, Johanna
AU - Matikainen, Mika
AU - Petas, Anssi
AU - Taari, Kimmo
AU - Tammela, Teuvo
AU - Auvinen, Anssi
N1 - Funding Information:
This work was supported in part by a grant from the Academy of Finland (Grant No 311336 to Prof. Auvinen and Prof. Taari), and Finnish Cancer Organisations (to Prof. Auvinen), Competitive State Research Funding (VTR) administered by Pirkanmaa Hospital District (Project No.9X003), Finnish Cancer Organizations (to Prof. Rannikko), Jane and Aatos Erkko Foundation (to Prof. Rannikko), the National Institutes of Health/National Cancer Institute with a Cancer Centre Support Grant to the Memorial Sloan Kettering Cancer Centre (P30 CA008748), a SPORE grant in Prostate Cancer to Dr H. Scher [P50 CA092629]. This work was also supported in part by the Swedish Cancer Society (CAN 2017/559), the Swedish Research Council (VR‐MH project no. 2016‐02974), and General Hospital in Malmö Foundation for Combating Cancer.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1111/bju.15683
DO - 10.1111/bju.15683
M3 - Article
AN - SCOPUS:85122654060
SN - 1464-4096
VL - 130
JO - BJU International
JF - BJU International
IS - 2
ER -