Prostate CancerNorDCaP ASNCT04627948
STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
An observational study of Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stockholm3 test
- How many people
- 199 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2019to 1 Jul 2024
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men diagnosed with low-risk PC, currently on AS and planned for follow-up with biopsies from the different inclusion sites will be invited to the study. Potential participants will be invited to the study by their urologist at their yearly follow up.
Who may be able to join
- Men diagnosed with low-risk PC and currently on AS and planned for follow-up with systematic and/or fusion biopsies as following standard of care.
Who cannot join
- History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.
Read the detailed description
STHLM3 AS NorDCaP is a cross-sectional multi-center study, evaluating the predictive value of Stockholm3 test in a prostate cancer cohort on AS for upgrading on rebiopsy. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional investigations, sampling will be synchronized with timing for planned follow-up within the AS program for each individual.
At baseline blood will be drawn for Stockholm3 analyses. The patient will be asked to fill out an informed consent. For each man the following data will be collected: Stockholm3 Risk Score, Stockholm3 Prostate Volume cut-off, total PSA, DRE status, MRI results (PI-RADS, optional, only if MRI is conducted within 3 months before biopsy), prostate volume, biopsy results (ISUP, cancer length, number of positive cores, total number of cores and stage).
Main outcome measurement will be number of upgrading, i.e. number of detected ISUP ≥ 2 cancers.
- Conditions
- Prostate Cancer
- Being tested
- Stockholm3 test
- Keywords
- Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stockholm3 testDiagnostic test
Diagnostic test: Stockholm3-test. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading
Number of ISUP ≥ 2 prostate cancer
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, University of Aarhus, Mehiläinen, Finland, St Goran's Hospital
- Responsible party
- Principal investigator, Anna Lantz, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627948
- Sponsor's protocol ID
- 2019-02020
- Other IDs
- 2019
- Acronym
- NorDCaP AS
- Status last verified
- Dec 2022
- First submitted
- 5 Nov 2020
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. All data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the National Biobank Act and other relevant laws. Everyone who works with STHLM3 AS NorDCaP are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced. Treatment of the personal data is in accordance with GDPR and other relevant national laws.
Publications
Giudici N, Scuderi S, Palsdottir T, Nordstrom T, Eklund M, Jensby EF, Borre M, Pedersen BG, Gronberg H, Sorensen KD, Kjosavik SR, Lantz A. STHLM3 NorDCaP: prospective multicentre trial of Stockholm3 for active surveillance biopsy guidance. BJU Int. 2026 Sep;138(3):471-479. doi: 10.1111/bju.70366. Epub 2026 Jul 1.
PubMed 42383465
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04627948
- Acronym / sponsor ID
- NorDCaP AS / 2019-02020
- Conditions
- Prostate Cancer
- Keywords
- Active Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, University of Aarhus, Mehiläinen, Finland, St Goran's Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Nov 2020 (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.
The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.
Detailed description
STHLM3 AS NorDCaP is a cross-sectional multi-center study, evaluating the predictive value of Stockholm3 test in a prostate cancer cohort on AS for upgrading on rebiopsy. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional investigations, sampling will be synchronized with timing for planned follow-up within the AS program for each individual.
At baseline blood will be drawn for Stockholm3 analyses. The patient will be asked to fill out an informed consent. For each man the following data will be collected: Stockholm3 Risk Score, Stockholm3 Prostate Volume cut-off, total PSA, DRE status, MRI results (PI-RADS, optional, only if MRI is conducted within 3 months before biopsy), prostate volume, biopsy results (ISUP, cancer length, number of positive cores, total number of cores and stage).
Main outcome measurement will be number of upgrading, i.e. number of detected ISUP ≥ 2 cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men diagnosed with low-risk PC, currently on AS and planned for follow-up with biopsies from the different inclusion sites will be invited to the study. Potential participants will be invited to the study by their urologist at their yearly follow up.
Key inclusion criteria (1 listed)
- Men diagnosed with low-risk PC and currently on AS and planned for follow-up with systematic and/or fusion biopsies as following standard of care.
Key exclusion criteria (2 listed)
- History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
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 |
|---|---|---|
| Stockholm3 testDiagnostic test: Stockholm3-test. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. | Diagnostic test | – |
Primary outcome
Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading
Time frame: Through study completion, an average of 1 year
Number of ISUP ≥ 2 prostate cancer
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 21 Jan 2025.
- Derived from this study: PubMed 42383465Giudici N, Scuderi S, Palsdottir T, Nordstrom T, Eklund M, Jensby EF, Borre M, Pedersen BG, Gronberg H, Sorensen KD, Kjosavik SR, Lantz A. STHLM3 NorDCaP: prospective multicentre trial of Stockholm3 for active surveillance biopsy guidance. BJU Int. 2026 Sep;138(3):471-479. doi: 10.1111/bju.70366. Epub 2026 Jul 1.
- Individual participant dataSharing planned: No. Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. All data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the National Biobank Act and other relevant laws. Everyone who works with STHLM3 AS NorDCaP are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced. Treatment of the personal data is in accordance with GDPR and other relevant national laws.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 2 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 21 Jan 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?
Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading (time frame: Through study completion, an average of 1 year). 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 NCT04627948, 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 21 Jan 2025.