Authors' objectives: The objective of this STA was to appraise the evidence provided in the submission file from A3P Biomedical (submitter) concerning the use of the Stockholm3 test for estimating the risk of prostate cancer compared with using only prostate-specific antigen (PSA). We also appraised the cost-minimisation analysis and budget impact analysis provided by the submitter.

Authors' results and conclusions: Clinical effectiveness The submitter included eight studies in their literature review. However, these eight studies do not represent eight independent samples. All studies compared Stockholm3 with PSA and were conducted in Sweden and/or Norway. None of the studies has been conducted by an independent research group. All studies excluded patients with previous prostate cancer diagnosis. One of the studies was a randomized controlled trial. The others were prospective paired diagnostic studies or observational studies. The largest study (Grönberg 2015) which was a prospective, population-based, paired, screen-positive, diagnostic study with more than 58,000 participants reported that use of the Stockholm3 model could reduce the number of biopsies by 32% (95% CI 24–39), could avoid 44% (35–54) of benign biopsies, and reduce unnecessary biopsies by 37%. It was not feasible to pool the results from the studies presented in the submission, due to variations in designs and research questions. Health economics Testing with Stockholm3 entails an additional direct costs of XXXX NOK per test. However, the submitted analysis indicates that it could be a cost-saving strategy compared to PSA testing alone. The analysis shows cost-savings of 1,400 NOK per man. The submitted budget impact analysis also indicates cost savings each year after implementation of Stockholm3.

Authors' methods: The appraisal included assessment of the quality of the literature search, the submitter’s summary of the prognostic accuracy of the Stockholm3 test, and the cost-minimization and budget impact analyses provided by the submitter. This implies that NIPH has not performed additional literature searches, any compilations of effects and safety, nor conducted any supplementary health economic analyses.

Project Status: Completed

Year Published: 2023

URL for published report: https://www.fhi.no/en/publ/2024/Stockholm3-test-to-estimate-the-risk-of-prostate-cancer/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo