STHLM3 - Prostate cancer diagnostic trial

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Micoli C, Crippa A, Connor JT, I‐SPY COVID Consortium, Eklund M, Discacciati A.

2026-01-011 citations

10.1002/pst.70050

Digital Rectal Examination in Stockholm3 Biomarker-based Prostate Cancer Screening

Joel Andersson, Thorgerdur Palsdottir, Anna Lantz, Markus Aly, Henrik Grönberg et al. (8 authors)

European Urology Open Science2022-08-2912 citations

10.1016/j.euros.2022.08.006

Artificial intelligence for diagnosis and grading of prostate cancer in biopsies: a population-based, diagnostic study.

Ström P, Kartasalo K, Olsson H, Solorzano L, Delahunt B, Berney DM, Bostwick DG, Evans AJ, Grignon DJ, Humphrey PA, Iczkowski KA, Kench JG, Kristiansen G, van der Kwast TH, Leite KRM, McKenney JK, Oxley J, Pan CC, Samaratunga H, Srigley JR, Takahashi H, Tsuzuki T, Varma M, Zhou M, Lindberg J, Lindskog C, Ruusuvuori P, Wählby C, Grönberg H, Rantalainen M, Egevad L, Eklund M.

2020-01-08385 citations

10.1016/s1470-2045(19)30738-7

Effects of increasing the PSA cutoff to perform additional biomarker tests before prostate biopsy.

Nordström T, Adolfsson J, Grönberg H, Eklund M.

2017-10-034 citations

10.1186/s12894-017-0281-8

Prostate cancer screening in men aged 50 to 69 years (STHLM3): A prospective population-based diagnostic study. Grönberg H, Adolfsson J, Aly M, Nordström T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M.Lancet Oncol. 2015 Dec;16(16):1667-76. [Epub 2015 Nov 10]. doi: 10.1016/S1470-2045(15)00361-7.

Scott E, Adolfsson J, Aly M, Nordström T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M.

2017-03-012 citations

10.1016/j.urolonc.2016.03.013

The risk-based STHLM3 model to improve prostate cancer testing in men 50-69 years: Further health, economic, and clinic evaluation.

Henrik Grönberg, Jan Adolfsson, Markus Aly, Tobias Nordström, Peter Wiklund et al. (12 authors)

Journal of Clinical Oncology2016-01-10

10.1200/jco.2016.34.2_suppl.36

Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study.

Grönberg H, Adolfsson J, Aly M, Nordström T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M.

2015-11-10287 citations

10.1016/s1470-2045(15)00361-7

Interventions

The two study arms will be: Control/PSA arm, where referral to biopsy will be based on Prostate-specific antigen (PSA) only with PSA = 3 as the level of referral to prostate biopsy

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: All men between 50 and 69 years of age who have a permanent postal address in Stockholm County Council or Region Gotland (N=260,000) will be asked whether they would like to take part in STHLM3.

Exclusion criteria

Exclusion criteria: Diagnosed with prostate cancer

Design outcomes

Primary

Measure	Time frame
To increase the specificity of a combined prostate cancer test compared to the PSA test without decreasing the sensitivity of high risk of prostate cancers (defined as Gleason 7 or higher). The primary endpoint is number of prostate biopsies.	—

Secondary

Measure	Time frame
1. To decrease the number of low risk prostate cancers diagnosed 2. To increase the health related quality of life and knowledge of prostate cancer testing 3. To assess the health economic consequences of implementing prostate cancer screening 4. To improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm 5. To assess the overall long-term mortality of prostate cancer in the Stockholm/Gotland area over a 10-15 year period 6. To assess the combination of a blood based ?best biomarker panel? and urine biomarkers in men with initial negative prostate biopsy (separate study protocol STHLM3-Rebiopsy) and 7. To facilitate inclusion in active surveillance protocol in men diagnosed with low risk prostate cancers	—

Measure

Time frame

1. To decrease the number of low risk prostate cancers diagnosed 2. To increase the health related quality of life and knowledge of prostate cancer testing 3. To assess the health economic consequences of implementing prostate cancer screening 4. To improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm 5. To assess the overall long-term mortality of prostate cancer in the Stockholm/Gotland area over a 10-15 year period 6. To assess the combination of a blood based ?best biomarker panel? and urine biomarkers in men with initial negative prostate biopsy (separate study protocol STHLM3-Rebiopsy) and 7. To facilitate inclusion in active surveillance protocol in men diagnosed with low risk prostate cancers

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Countries

Sweden

Outcome results

None listed