Prostate CancerPSA2STHLM3/1NCT03381105
From PSA to Stockholm3: Study Part 1
An observational study of Prostate Cancer, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA and Stockholm3
- How many people
- 13,431 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2017to 31 Dec 2030
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All men at risk of prostate cancer in the 18 municipalities covered by Stavanger University Hospital
Who may be able to join
- All men where a physicians in regular clinical work finds that there is an indication to take the test
Who cannot join
- known prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.
Read the detailed description
Background:
Prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in Norway. It is also the leading cause of cancer death among men, and nearly 1100 Norwegian men died from prostate cancer in 2014. However, only about 30 percent of new cases have an aggressive form of the disease. Therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer.
The Prostate-Specific Antigen (PSA) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. PSA is used for screening in many countries, but the Norwegian authorities consider the harms of using PSA for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). Nevertheless, it has been documented that a substantial amount of opportunistic PSA screening takes place in Norway.
At present, a novel test called the Stockholm3 test has been developed. A large prospective study has shown that the efficacy of the Stockholm3 test is superior to PSA, and both the sensitivity and the specificity are substantially higher for Stockholm3 than for PSA.
Aim The aim of this study is to analyze the effectiveness of the Stockholm3 test in regular clinical practice, including both primary care and specialized health care.
Study Design From September 2017, the urological department at Stavanger University Hospital requires a Stockholm3 answer in referrals of patients for further diagnostics of possible prostate cancer.
Comparable clinical data will be collected for a period before - and from a corresponding period after the Stockholm3 test was taken into use.
An analysis will then be carried out where the results from the period where referrals were based primarily on PSA will be compared with the results for the period in which the Stockholm 3 test was used.
Power calculation Based on results from the original Stockholm3 study and aggregated figures regarding PSA testing, prostate biopsies and MRI of the prostate in Stockholm and Stavanger, a statistical power has been calculated. Based on a two-sided alpha at 0.05 (i.e., 5%) and a 90% power the study need about 8000 participants to reliably answer the main study questions. An interim analysis will be conducted in the inclusion phase. A new power calculation will be performed based on the registered data, and the need of participants will be adjusted if necessary.
- Conditions
- Prostate Cancer
- Being tested
- PSA and Stockholm3
- Keywords
- Diagnostics, over-diagnosis
- 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 and Stockholm3Diagnostic test
The new Stockholm3 test and traditional PSA test
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6
The percentage of patients whose prostate biopsies showed a Gleason score ≤ 6 or ≥7 among those referred for diagnostics based on a PSA test or a Stockholm3 test
Measured: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
Secondary outcomes (1)
Rate of prostate biopsies among patients tested with PSA and Stockholm3
The percentage of patients referred for further diagnosis of potential prostate cancer with biopsy among those who were tested with PSA over a period of time, compared to those tested with Stockholm3 for a corresponding period of time
Measured: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2030 (estimated)
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.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Svein Kjosavik, MS PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381105
- Sponsor's protocol ID
- SUSID_637
- Acronym
- PSA2STHLM3/1
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2017
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gronberg H, Adolfsson J, Aly M, Nordstrom T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol. 2015 Dec;16(16):1667-76. doi: 10.1016/S1470-2045(15)00361-7. Epub 2015 Nov 10.
PubMed 26563502
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
- ClinicalTrials.gov ID
- NCT03381105
- Acronym / sponsor ID
- PSA2STHLM3/1 / SUSID_637
- Conditions
- Prostate Cancer
- Keywords
- Diagnostics, over-diagnosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13,431 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Dec 2017 (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 part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.
Detailed description
Background:
Prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in Norway. It is also the leading cause of cancer death among men, and nearly 1100 Norwegian men died from prostate cancer in 2014. However, only about 30 percent of new cases have an aggressive form of the disease. Therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer.
The Prostate-Specific Antigen (PSA) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. PSA is used for screening in many countries, but the Norwegian authorities consider the harms of using PSA for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). Nevertheless, it has been documented that a substantial amount of opportunistic PSA screening takes place in Norway.
At present, a novel test called the Stockholm3 test has been developed. A large prospective study has shown that the efficacy of the Stockholm3 test is superior to PSA, and both the sensitivity and the specificity are substantially higher for Stockholm3 than for PSA.
Aim The aim of this study is to analyze the effectiveness of the Stockholm3 test in regular clinical practice, including both primary care and specialized health care.
Study Design From September 2017, the urological department at Stavanger University Hospital requires a Stockholm3 answer in referrals of patients for further diagnostics of possible prostate cancer.
Comparable clinical data will be collected for a period before - and from a corresponding period after the Stockholm3 test was taken into use.
An analysis will then be carried out where the results from the period where referrals were based primarily on PSA will be compared with the results for the period in which the Stockholm 3 test was used.
Power calculation Based on results from the original Stockholm3 study and aggregated figures regarding PSA testing, prostate biopsies and MRI of the prostate in Stockholm and Stavanger, a statistical power has been calculated. Based on a two-sided alpha at 0.05 (i.e., 5%) and a 90% power the study need about 8000 participants to reliably answer the main study questions. An interim analysis will be conducted in the inclusion phase. A new power calculation will be performed based on the registered data, and the need of participants will be adjusted if necessary.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All men at risk of prostate cancer in the 18 municipalities covered by Stavanger University Hospital
Key inclusion criteria (1 listed)
- All men where a physicians in regular clinical work finds that there is an indication to take the test
Key exclusion criteria (1 listed)
- known prostate cancer
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 and Stockholm3The new Stockholm3 test and traditional PSA test | Diagnostic test | – |
Primary outcome
Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6
Time frame: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
The percentage of patients whose prostate biopsies showed a Gleason score ≤ 6 or ≥7 among those referred for diagnostics based on a PSA test or a Stockholm3 test
1 secondary outcome
Rate of prostate biopsies among patients tested with PSA and Stockholm3
Time frame: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
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 24 Apr 2023.
- Background: PubMed 26563502Gronberg H, Adolfsson J, Aly M, Nordstrom T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol. 2015 Dec;16(16):1667-76. doi: 10.1016/S1470-2045(15)00361-7. Epub 2015 Nov 10.
- Individual participant dataSharing planned: No
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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.
Svein Kjosavik, MS PhD principal investigator
Helse Stavanger HF
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 Helse Stavanger HF at 1 site in Norway.
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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2023. 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 Norway. 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?
Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6 (time frame: 9 to 12 months from september 2017 compared with a corresponding period one year earlier). 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 NCT03381105, 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 24 Apr 2023.