Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
STHLM3 - Prostate cancer diagnostic randomized trial
Acronym
STHLM3
Study hypothesis
STHLM3 [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
Stockholm Ethical Review Board, 09/05/2012, ref: r DNR 2012/572-31/1
Study design
Two-armed randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Patient information in Swedish can be found at http://sthlm3.se/dokument/
Condition
Prostate cancer
Intervention
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
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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/01/2013
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
All
Age group
Adult
Gender
Male
Target number of participants
140,000
Participant exclusion criteria
Diagnosed with prostate cancer
Recruitment start date
01/01/2013
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Nobels väg 12
Stockholm
17177
Sweden
Sponsor information
Organisation
Karolinska Institutet (Sweden)
Sponsor details
Department of Medical Epidemiology and Biostatistics
PO Box 281
Stockholm
17177
Sweden
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden)
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26563502