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

Rannikko, Antti ; Leht, Mare ; Mirtti, Tuomas ; Kenttämies, Anu ; Tolonen, Teemu ; Rinta-Kiikka, Irina ; Kilpeläinen, Tuomas P. ; Natunen, Kari ; Lilja, Hans LU orcid and Lehtimäki, Terho , et al. (2022) In BJU International 130(2). p.193-199
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
BJU International
volume
130
issue
2
pages
193 - 199
publisher
John Wiley & Sons Inc.
external identifiers
  • scopus:85122654060
  • pmid:34958531
ISSN
1464-4096
DOI
10.1111/bju.15683
language
English
LU publication?
yes
id
c7e785a3-5210-4762-a876-a638d3004bfe
date added to LUP
2022-03-07 11:47:08
date last changed
2025-03-15 17:49:07
@article{c7e785a3-5210-4762-a876-a638d3004bfe,
  abstract     = {{<p>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 &gt;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.</p>}},
  author       = {{Rannikko, Antti and Leht, Mare and Mirtti, Tuomas and Kenttämies, Anu and Tolonen, Teemu and Rinta-Kiikka, Irina and Kilpeläinen, Tuomas P. and Natunen, Kari and Lilja, Hans and Lehtimäki, Terho and Raitanen, Jani and Kujala, Paula and Ronkainen, Johanna and Matikainen, Mika and Petas, Anssi and Taari, Kimmo and Tammela, Teuvo and Auvinen, Anssi}},
  issn         = {{1464-4096}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{193--199}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{BJU International}},
  title        = {{Population-based randomized trial of screening for clinically significant prostate cancer ProScreen : a pilot study}},
  url          = {{http://dx.doi.org/10.1111/bju.15683}},
  doi          = {{10.1111/bju.15683}},
  volume       = {{130}},
  year         = {{2022}},
}