STHLM3 - Prostate cancer diagnostic trial
| ISRCTN | ISRCTN84445406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84445406 |
| Protocol serial number | N/A |
| Sponsor | Karolinska Institutet (Sweden) |
| Funder | Stockholm County Council (Sweden) |
- 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
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
Contact information
Scientific
Nobels väg 12
Stockholm
17177
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | STHLM3 - Prostate cancer diagnostic randomized trial |
| Study acronym | STHLM3 |
| Study objectives | 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(s) | Stockholm Ethical Review Board, 09/05/2012, ref: r DNR 2012/572-31/1 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. To decrease the number of low risk prostate cancers diagnosed |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 140000 |
| Key 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. |
| Key exclusion criteria | Diagnosed with prostate cancer |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Sweden
Study participating centre
17177
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2022: Publication reference added.
19/07/2016: Plain English summary added.
04/05/2016: Publication reference added.
