Prostate CancerNCT07206693
Impact of PSA-based Screening on Mortality Among Men Aged 75-79: Target Trial Emulation
An observational study of Prostate Cancer and Prostate Cancer Screening, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Opportunistic prostate-specific antigen (PSA) testing is widespread among men aged 75-79. Current American and European guidelines recommend PSA-based screening through shared decision-making if men are expected to live at least 10 more years-a threshold previously tied to ages 70-74. Read more about this study
- Who is it for?
- Ages 75 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Screening, Prostate Cancer Screening Decision
- What is being tested?
- Prostate specific antigen (PSA)
- How many people
- 257,275 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2007to 31 Dec 2023
- How long will I take part?
- 17 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 to 79 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: This study and the target-trial emulation will use population-based register data of men living in Stockholm between 2007-2023 screened for prostate cancer, extracted from the Stockholm Prostate Cancer Diagnostics Register (STHLM0). STHLM0 has complete PSA test records since 1 January 2007. This will be supplemented with information on non-tested men from the STHLM0+ register. Demographic information, family history of prostate cancer, diagnoses, hospitalization, specialized outpatient healthcare, prostate cancer treatment, and mortality information are provided from the linked Swedish population registers
Who may be able to join
- Men aged 75-79 between 2007-2023, with no prostate cancer diagnosis at the time of inclusion (based on each trial emulation) will be considered eligible for the trials. To ensure proper control for potential confounding, and to be able to evaluate the eligibility criteria, only men with complete information on their screening status, outcomes, and confounders in the registers will be included.
Who cannot join
- Men younger than 75 or older than 79 between 2007-2023. Have prostate cancer diagnosis at the time of inclusion (based on each trial emulation) Missing data on the exposure, outcomes, and confounders.
Trial locations and contacts
1 site in 1 country.
About this study
Opportunistic prostate-specific antigen (PSA) testing is widespread among men aged 75-79. Current American and European guidelines recommend PSA-based screening through shared decision-making if men are expected to live at least 10 more years-a threshold previously tied to ages 70-74. With rising life expectancy, Swedish men aged 75-79 now exceed this benchmark, averaging over 10 years.
Since no randomized controlled trials have examined screening in this age group, this study will use data from the Stockholm Prostate Cancer Diagnostics Register (2007-2023) to emulate a target trial. Men without prior prostate cancer will be assigned to screened or unscreened groups based on PSA test records and followed until death or December 2023. Analyses will use survival models, cumulative incidence functions, and sensitivity checks (e.g., varying follow-up duration, calendar year vs. age enrollment, and comparisons with men aged 65-69).
The goal is to determine whether PSA screening at ages 75-79 improves overall and prostate cancer-specific survival, and whether guidelines should expand to include this group while balancing the risk of overdiagnosis. Results will inform both clinical practice and the design of future randomized trials.
- Conditions
- Prostate Cancer, Prostate Cancer Screening, Prostate Cancer Screening Decision, Prostate Specific Antigen Screening
- Being tested
- Prostate specific antigen (PSA)
- Keywords
- prostate cancer, screening, prostate specific antigen, older adults, urology, mortality, emulation of target trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate specific antigen (PSA)Diagnostic test
Prostate specific antigen (PSA) for prostate cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Men aged 75-79 living in Stockholm from 2007-2023 | Not described Receives: Diagnostic Test: Prostate specific antigen (PSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 17 years
Prostate-cancer specific mortality
Measured: 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2007
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257,275 participants (actual)
- Target duration
- 17 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Nordström, Karolinska Institutet
- Investigators
- Tobias Nordström, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206693
- Sponsor's protocol ID
- 2012/438-31/3
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publically because of restrictions from Swedish laws and GDPR. However, the IPD can be requested from the study PI following approval from the Swedish ethics committee, and approval of the data sharing agreement between the two institutions at Karolinska Institutet.
Publications
Abbadi A, Micoli C, Discacciati A, Olarte Parra C, Lantz A, Bjornebo L, Arvendell M, Chandra Engel J, Andersson J, Falagario U, Gronberg H, Eklund M, Clements M, Nordstrom T. Can Prostate Cancer Screening Reduce Mortality in Men Aged 75-79 Years? A Protocol for Target-trial Emulation. Eur Urol Open Sci. 2025 Nov 6;82:147-154. doi: 10.1016/j.euros.2025.10.016. eCollection 2025 Dec.
PubMed 41280154
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PSA-based Screening on Mortality Among Men Aged 75-79: Target Trial Emulation
- ClinicalTrials.gov ID
- NCT07206693
- Acronym / sponsor ID
- 2012/438-31/3
- Conditions
- Prostate Cancer, Prostate Cancer Screening, Prostate Cancer Screening Decision, Prostate Specific Antigen Screening
- Keywords
- prostate cancer, screening, prostate specific antigen, older adults, urology, mortality, emulation of target trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257,275 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Oct 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.
Opportunistic prostate-specific antigen (PSA) testing is widespread among men aged 75-79. Current American and European guidelines recommend PSA-based screening through shared decision-making if men are expected to live at least 10 more years-a threshold previously tied to ages 70-74. With rising life expectancy, Swedish men aged 75-79 now exceed this benchmark, averaging over 10 years.
Since no randomized controlled trials have examined screening in this age group, this study will use data from the Stockholm Prostate Cancer Diagnostics Register (2007-2023) to emulate a target trial. Men without prior prostate cancer will be assigned to screened or unscreened groups based on PSA test records and followed until death or December 2023. Analyses will use survival models, cumulative incidence functions, and sensitivity checks (e.g., varying follow-up duration, calendar year vs. age enrollment, and comparisons with men aged 65-69).
The goal is to determine whether PSA screening at ages 75-79 improves overall and prostate cancer-specific survival, and whether guidelines should expand to include this group while balancing the risk of overdiagnosis. Results will inform both clinical practice and the design of future randomized trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men aged 75-79 living in Stockholm from 2007-2023 | – | Diagnostic Test: Prostate specific antigen (PSA) |
Who may qualify
- Ages
- 75 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study and the target-trial emulation will use population-based register data of men living in Stockholm between 2007-2023 screened for prostate cancer, extracted from the Stockholm Prostate Cancer Diagnostics Register (STHLM0). STHLM0 has complete PSA test records since 1 January 2007. This will be supplemented with information on non-tested men from the STHLM0+ register. Demographic information, family history of prostate cancer, diagnoses, hospitalization, specialized outpatient healthcare, prostate cancer treatment, and mortality information are provided from the linked Swedish population registers
Key inclusion criteria (1 listed)
- Men aged 75-79 between 2007-2023, with no prostate cancer diagnosis at the time of inclusion (based on each trial emulation) will be considered eligible for the trials. To ensure proper control for potential confounding, and to be able to evaluate the eligibility criteria, only men with complete information on their screening status, outcomes, and confounders in the registers will be included.
Key exclusion criteria (1 listed)
- Men younger than 75 or older than 79 between 2007-2023. Have prostate cancer diagnosis at the time of inclusion (based on each trial emulation) Missing data on the exposure, outcomes, and confounders.
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 |
|---|---|---|
| Prostate specific antigen (PSA)Prostate specific antigen (PSA) for prostate cancer screening | Diagnostic test | Men aged 75-79 living in Stockholm from 2007-2023 |
Primary outcome
All-cause mortality
Time frame: 17 years
Prostate-cancer specific mortality
Time frame: 17 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 41280154Abbadi A, Micoli C, Discacciati A, Olarte Parra C, Lantz A, Bjornebo L, Arvendell M, Chandra Engel J, Andersson J, Falagario U, Gronberg H, Eklund M, Clements M, Nordstrom T. Can Prostate Cancer Screening Reduce Mortality in Men Aged 75-79 Years? A Protocol for Target-trial Emulation. Eur Urol Open Sci. 2025 Nov 6;82:147-154. doi: 10.1016/j.euros.2025.10.016. eCollection 2025 Dec.
- Individual participant dataSharing planned: No. IPD will not be shared publically because of restrictions from Swedish laws and GDPR. However, the IPD can be requested from the study PI following approval from the Swedish ethics committee, and approval of the data sharing agreement between the two institutions at Karolinska Institutet.
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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, MD PhD 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?
An observational study of Prostate Cancer and Prostate Cancer Screening, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause mortality (time frame: 17 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?
On the ClinicalTrials.gov record for NCT07206693, which also lists 1 linked publication.
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 3 Oct 2025.