ISRCTN ISRCTN84445406
DOI https://doi.org/10.1186/ISRCTN84445406
Secondary identifying numbers N/A
Submission date
14/11/2012
Registration date
03/01/2013
Last edited
04/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Prostate cancer is a leading cause of cancer death among men in the Western world. A PSA test looks for raised levels of PSA in the blood that may be a sign of prostate cancer in its early stages. Although PSA screening has been shown to prevent deaths, it can also lead to over-diagnosis (diagnosis of disease that would not have caused symptoms or death) and performing unnecessary biopsies (where a sample of the prostate is taken for diagnosis). The aim of this study is to assess whether a new biomarker test for prostate cancer can reduce how many men are referred to biopsy whilst still detecting high-risk prostate cancer. The study will also assess whether the new test decreases the number of low-risk prostate cancers diagnosed and improves the quality and effectiveness of prostate cancer diagnosis in routine health care in Stockholm.

Who can participate?
Men aged 50 to 69 living in Stockholm County Council or Region Gotland who have not previously been diagnosed with prostate cancer

What does the study involve?
Participants are randomly allocated to one of two groups. One group are referred to biopsy based on the PSA test result only. The other group are referred to biopsy based on their age, their genes, their family history and biomarkers.

What are the possible benefits and risks of participating?
There are no benefits for the participants other than a free prostate cancer test. There is a low risk of over-diagnosis of low-risk cancers.

Where is the study run from?
Karolinska Institutet (Sweden)

When is the study starting and how long is it expected to run for?
January 2013 to December 2014

Who is funding the study?
Stockholm County Council (Sweden)

Who is the main contact?
Prof. Henrik Grönberg

Study website

Contact information

Prof Henrik Grönberg
Scientific

Nobels väg 12
Stockholm
17177
Sweden

Study information

Study designTwo-armed randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Patient information in Swedish can be found at http://sthlm3.se/dokument/
Scientific titleSTHLM3 - Prostate cancer diagnostic randomized trial
Study acronymSTHLM3
Study objectivesSTHLM3 [STHLM relates to the city of Stockholm, Number 3 relates to that this is the third study within the same setting] is a randomized controlled trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for high risk prostate cancer.
Ethics approval(s)Stockholm Ethical Review Board, 09/05/2012, ref: r DNR 2012/572-31/1
Health condition(s) or problem(s) studiedProstate cancer
InterventionThe 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

Intervention/Best biomarker panel (BBP) arm, where referral to biopsy will be determined by a risk prediction model based on age, an array of single-nucleotide polymorphism (SNPs), family history and protein-based biomarkers.
Intervention typeOther
Primary outcome measureTo 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 outcome measures1. 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
Overall study start date01/01/2013
Completion date31/12/2014

Eligibility

Participant type(s)All
Age groupAdult
SexMale
Target number of participants140,000
Key inclusion criteriaAll 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.
Key exclusion criteriaDiagnosed with prostate cancer
Date of first enrolment01/01/2013
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • Sweden

Study participating centre

Nobels väg 12
Stockholm
17177
Sweden

Sponsor information

Karolinska Institutet (Sweden)
Research organisation

Department of Medical Epidemiology and Biostatistics
PO Box 281
Stockholm
17177
Sweden

Website http://ki.se/ki/jsp/polopoly.jsp?l=en&d=9600
ROR logo "ROR" https://ror.org/056d84691

Funders

Funder type

Government

Stockholm County Council (Sweden)
Government organisation / Local government
Alternative name(s)
Stockholm County Council
Location
Sweden

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2015 Yes No
Results article 29/08/2022 04/10/2022 Yes No

Editorial Notes

04/10/2022: Publication reference added.
19/07/2016: Plain English summary added.
04/05/2016: Publication reference added.