Prostate CancerSTHLM3MRI_3NCT07155759
Long-term Outcomes of Prostate Cancer Screening
A study testing PSA/Stockholm3/MRI and PSA in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and… Read more about this study
- Who is it for?
- Ages 50 to 74 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA/Stockholm3/MRI and PSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to Nov 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).
- Permanent postal address in Stockholm
- Not a previous participant in the Stockholm3 study (2012-2014)
Who cannot join
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
- Men with a previous prostate biopsy the preceding 60 days before invitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.
- Conditions
- Prostate Cancer
- Being tested
- PSA/Stockholm3/MRI, PSA
- Keywords
- screening, magnetic resonance imaging, biomarker, mortality, stockholm3
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA/Stockholm3/MRIDiagnostic test
Stockholm3+PSA followed by MRI of the prostate
PSADiagnostic test
PSA followed by standard biopsies
| Study group | Role | What they receive |
|---|---|---|
| Organized screening including repeat testing (MRI+biomarkers) | Experimental | participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA>=3 | Stockholm3>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6 Receives: Diagnostic Test: PSA/Stockholm3/MRI |
| One-time invitation to testing arm (traditional biopsies) | Active comparator | participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered. Receives: Diagnostic Test: PSA |
| Population controls | No intervention | Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer mortality
Mortality from prostate cancer (yes/no)
Measured: 5-10 years
Detection of clinically significant prostate cancer
Gleason Score ≥7 disease detected (Yes/No)
Measured: 1-3 years
Secondary outcomes (5)
Prostate cancer metastasis-free survival
Measured: 5-10 years
Detection of prostate cancer by grade
ISUP (International Society of UroPathology) grade group 1-5
Measured: 1-3 years
Performed prostate biopsy
Participant undergone a biopsy procedure of the prostate (Yes/No)
Measured: 1-3 years
Performed MRI of prostate
Measured: 1-3 years
Grading of MRI prostate
PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS)
) score (1-5)
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation, The Swedish Research Council
- Responsible party
- Principal investigator, Tobias Nordström, Karolinska Institutet
- Investigators
- Tobias Nordström, Ass Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155759
- Sponsor's protocol ID
- STHLM3MRI_3
- Acronym
- STHLM3MRI_3
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in this project will be available after deidentification, together with the study protocol, statistical analysis plan, and analytic code. Data will be made available to researchers who provide a methodologically robust proposal, in which the aims are relevant and clear. Proposals can be submitted up to 24 months after publication of the first main article of the project and should be directed to tobias.nordstrom@ki.se. Only proposals with ethical approval will be granted access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial
- ClinicalTrials.gov ID
- NCT07155759
- Acronym / sponsor ID
- STHLM3MRI_3 / STHLM3MRI_3
- Conditions
- Prostate Cancer
- Keywords
- screening, magnetic resonance imaging, biomarker, mortality, stockholm3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation, The Swedish Research Council
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Organized screening including repeat testing (MRI+biomarkers) | Experimental | Diagnostic Test: PSA/Stockholm3/MRIparticipants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA>=3 | Stockholm3>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6 |
| One-time invitation to testing arm (traditional biopsies) | Active comparator | Diagnostic Test: PSAparticipants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered. |
| Population controls | No intervention | –Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare) |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).
- Permanent postal address in Stockholm
- Not a previous participant in the Stockholm3 study (2012-2014)
Key exclusion criteria (3 listed)
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
- Men with a previous prostate biopsy the preceding 60 days before invitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA/Stockholm3/MRIStockholm3+PSA followed by MRI of the prostate | Diagnostic test | Organized screening including repeat testing (MRI+biomarkers) |
| PSAPSA followed by standard biopsies | Diagnostic test | One-time invitation to testing arm (traditional biopsies) |
Primary outcome
Prostate cancer mortality
Time frame: 5-10 years
Mortality from prostate cancer (yes/no)
Detection of clinically significant prostate cancer
Time frame: 1-3 years
Gleason Score ≥7 disease detected (Yes/No)
5 secondary outcomes
Prostate cancer metastasis-free survival
Time frame: 5-10 years
Detection of prostate cancer by grade
Time frame: 1-3 years
Performed prostate biopsy
Time frame: 1-3 years
Performed MRI of prostate
Time frame: 1-3 years
Grading of MRI prostate
Time frame: 1-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in this project will be available after deidentification, together with the study protocol, statistical analysis plan, and analytic code. Data will be made available to researchers who provide a methodologically robust proposal, in which the aims are relevant and clear. Proposals can be submitted up to 24 months after publication of the first main article of the project and should be directed to tobias.nordstrom@ki.se. Only proposals with ethical approval will be granted access to the data.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Nordström, Ass Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA/Stockholm3/MRI and PSA in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer mortality (time frame: 5-10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.