Prostate CancerNCT06748456
A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice
A study testing Podcast, Cluster meeting and Hand-out material 1 in people with Prostate Cancer and Evidence Based Medicine, run by University of Copenhagen at 1 site in Denmark.
Trial summary
It is widely acknowledged that prostate specific antigen (PSA) testing can lead to false-positives, overdiagnosis and overtreatment of prostate cancer. The current national clinical guidelines only recommend the test to a small group of patients and does not recommend neither systematic nor opportunistic screening for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer, Evidence Based Medicine, Prostate Specific Antigen
- What is being tested?
- Podcast, Cluster meeting and Hand-out material 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Sep 2024to 1 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Quality clusters with a cluster coordinator
- Quality clusters willing to participate in a cluster meeting with PSA as a theme in 2025.
Who cannot join
- Quality clusters who already planned their cluster meetings in 2025.
- Quality clusters unwilling to await allocation before planning their cluster meetings in 2025.
- Quality clusters participating in the pilot study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center of General Practice, Department of Public Health, University of Copenhagen
Copenhagen
Christian Leick, PhD student, 004560898397, christian.leick@sund.ku.dk
About this study
Official title: Development and Evaluation of a Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice: A Cluster Randomized Trial
It is widely acknowledged that prostate specific antigen (PSA) testing can lead to false-positives, overdiagnosis and overtreatment of prostate cancer. The current national clinical guidelines only recommend the test to a small group of patients and does not recommend neither systematic nor opportunistic screening for prostate cancer with the test.
The aim of this cluster randomized trial is to evaluate the effectiveness of a complex intervention aimed at improving the use of evidence based practice when using prostate specific antigen tests in general practice.
The complex intervention in this study is a so called cluster package which is meeting material to a quality cluster meeting as almost every general practitioner is a member of a quality cluster. Therefore, the investigators have developed a cluster package aimed at promoting an evidence-based use of the prostate specific antigen test to general practitioners.
Read the detailed description
Prostate cancer (PC) is the most common type of cancer among men in Denmark with an incidence of approximately 4.500 cases and 1.300 deaths every year. Usually prostate cancer develops very slowly and men with a detectable prostate tumor can live for many years without experiencing any symptoms. Autopsy studies of males who died of other causes finds PC in approximately 30 percent of males in their fifties and up to 70 percent of males in their seventies. From that perspective most men die with prostate cancer than because of it.
In Denmark the first examinations of a possible prostate cancer diagnosis take place in general practice. Every citizen in Denmark with a social security number has free and direct access to a general practitioner (GP) and works as a gatekeeper to the healthcare system. If the GP suspects prostate cancer in a patient the GP has the possibility to measure the level of prostate specific antigen (PSA) in a blood sample. If the level of PSA is high it may indicate the presence of prostate cancer.
However, according to the national clinical guidelines on detection and diagnostic investigation of prostate cancer the PSA-test is only recommended on a small patient group with very specific and rare symptoms. Furthermore they do not recommend neither systematic nor opportunistic screening with the PSA-test.
The reason for the rather restrictive guidelines for PSA-testing is to avoid overdiagnosis and overtreatment of prostate cancer. A high level of PSA in a blood sample is not necessarily due to prostate cancer but could also be elevated by other conditions such as cystitis or an enlarged benign prostate. Even if the further examinations at a urology department in a hospital finds prostate cancer in the patient it is potentially indolent cancer and not a clinically important tumor which is an prostate cancer overdiagnosis and could lead to unnecessary treatment which is overtreatment. The treatment of prostate cancer could cause harms such as impotence, incontinence and faecal incontinence.
Since 2018, GP's in Denmark has been encouraged to cluster in groups of other GP's from their local area to work with quality development and form so called quality clusters. The aim of these quality clusters was to create a medical professional forum where the GP's could meet 2-4 times a year and exchange experiences with each other in a specific clinically relevant area decided by the cluster itself. One of the main points of the quality cluster concept was that the quality development work should be based on descriptive data from their own GP clinics. At present 116 quality clusters exist in Denmark and includes 3.519 GP's in 1.542 GP clinics.
By the same time of the establishment of the quality cluster a national organization called KiAP (a Danish acronym for Quality in General Practice) was founded. The primary purpose was to support the quality clusters with their quality development work. One of the supportive initiatives by KiAP is the development of cluster packages which is meeting material for the quality clusters on their cluster meetings. A cluster packages has one specific clinically relevant theme and consists of data, expert videos, reflection questions among other things.
The investigators have chosen to develop a cluster package about PSA-tests in general practice with the purpose to promote an evidence-based practice. A pilot study will be conducted in the development process. The aim of the study is to evaluate the effectiveness of the cluster package. Since the study is a cluster randomized trial the investigators invited all the Danish quality clusters to agree to use the cluster package on one of their cluster meetings. The participating quality clusters are randomized to an intervention group and a control group.
- Being tested
- Podcast, Cluster meeting, Hand-out material 1, Hand-out material 2
- Keywords
- PSA-test, Prostate Cancer, Evidence based medicine, Quality clusters, General practice
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PodcastBehavioural
A pre-recorded podcast with a urologist and a GP discussing the theme to promote preparatory reflections among the GPs before the cluster meeting
Cluster meetingBehavioural
A two-hour meeting facilitated by either the GPs cluster coordinator, another GP from the cluster or a facilitator outside the cluster chosen by the cluster itself with specific slides about PSA in general, guidelines, expert videos, data from the clinics, cases, and group discussions
Hand-out material 1Behavioural
Hand-outs of the main take-home messages to facilitate further discussion in their respective GP offices
Hand-out material 2Behavioural
Hand-outs to be used by GP and patients to facilitate communication about the relevance of taking a PSA-test
| Study group | Role | What they receive |
|---|---|---|
| Cluster package intervention group | Experimental | The intervention consists of:
* A pre-recorded podcast to be heard by the GP's prior to the cluster meeting.
* A two-hour meeting with a specific slideshow about PSA, data from the clinics within the cluster, current guidelines, cases and group discussions.
* Two sets of hand-outs for the GP's to use in their own clinics.
The intervention group will be offered the intervention during the intervention period of six months. Receives: Behavioral: Podcast; Behavioral: Cluster meeting; Behavioral: Hand-out material 1; Behavioral: Hand-out material 2 |
| Standard care control group | No intervention | The control group will be offered the intervention at the end of the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of prostate specific antigen tests on unique men ≥40 taken by general practitioners
The primary outcome is a reduction in the prevalence of prostate specific antigen (PSA) test on unique men ≥40 taken at the level of the quality health cluster from six month pre-intervention until six months post-intervention, in the intervention group compared to the control group. The overall aim is to improve practice of evidence based medicine by general practitioners (GP's), therefore we do not attempt to remove all PSA-test taken, neither do we set a pre-defined number that needs to be achieved. However, when following Danish Guidelines for PSA-testing, only a very small proportion of males over 40 should have the test, and therefore we consider any reduction clinically relevant.
Measured: From cluster meeting to the end of intervention period at 6 months
Secondary outcomes (3)
Pre/post intervention change
The prevalence of PSA test on unique men ≥40 taken at each GP clinic from pre- to post-intervention
Measured: From cluster meeting to the end of intervention period at 6 months
High-user change
The change in the prevalence of PSA test on unique men ≥40 taken by the 10% highest users defined as all GP clinics
Measured: From cluster meeting to the end of intervention period at 6 months
Variance between GPs
The homogeneity in the prevalence of PSA tests on unique men ≥40 within each cluster in the intervention group
Measured: From cluster meeting to the end of intervention period at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start9 Sep 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a cluster randomized trial. The quality clusters are the participants (clusters) and randomization will take place at quality cluster level. Each cluster includes on average 13 GP clinics. The control group will be offered the intervention at the end of the intervention period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Kvalitet i Almen Praksis (KiAP)
- Responsible party
- Sponsor
- Investigators
- Marius Brostrøm Kousgaard, Associate professor, Principal investigator, Center of General Practice, Department of Public Health, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748456
- Sponsor's protocol ID
- 103342
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmkjaer P, Leick C, Drivsholm T, Siersma V, Bro F, Kousgaard MB. A cluster randomized trial to evaluate the effects of a quality cluster-based intervention on the use of prostate-specific antigen test in general practice-a study protocol. Trials. 2026 Jun 29. doi: 10.1186/s13063-026-09867-1. Online ahead of print.
PubMed 42374596
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06748456
- Acronym / sponsor ID
- 103342
- Keywords
- PSA-test, Prostate Cancer, Evidence based medicine, Quality clusters, General practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Kvalitet i Almen Praksis (KiAP)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
It is widely acknowledged that prostate specific antigen (PSA) testing can lead to false-positives, overdiagnosis and overtreatment of prostate cancer. The current national clinical guidelines only recommend the test to a small group of patients and does not recommend neither systematic nor opportunistic screening for prostate cancer with the test.
The aim of this cluster randomized trial is to evaluate the effectiveness of a complex intervention aimed at improving the use of evidence based practice when using prostate specific antigen tests in general practice.
The complex intervention in this study is a so called cluster package which is meeting material to a quality cluster meeting as almost every general practitioner is a member of a quality cluster. Therefore, the investigators have developed a cluster package aimed at promoting an evidence-based use of the prostate specific antigen test to general practitioners.
Detailed description
Prostate cancer (PC) is the most common type of cancer among men in Denmark with an incidence of approximately 4.500 cases and 1.300 deaths every year. Usually prostate cancer develops very slowly and men with a detectable prostate tumor can live for many years without experiencing any symptoms. Autopsy studies of males who died of other causes finds PC in approximately 30 percent of males in their fifties and up to 70 percent of males in their seventies. From that perspective most men die with prostate cancer than because of it.
In Denmark the first examinations of a possible prostate cancer diagnosis take place in general practice. Every citizen in Denmark with a social security number has free and direct access to a general practitioner (GP) and works as a gatekeeper to the healthcare system. If the GP suspects prostate cancer in a patient the GP has the possibility to measure the level of prostate specific antigen (PSA) in a blood sample. If the level of PSA is high it may indicate the presence of prostate cancer.
However, according to the national clinical guidelines on detection and diagnostic investigation of prostate cancer the PSA-test is only recommended on a small patient group with very specific and rare symptoms. Furthermore they do not recommend neither systematic nor opportunistic screening with the PSA-test.
The reason for the rather restrictive guidelines for PSA-testing is to avoid overdiagnosis and overtreatment of prostate cancer. A high level of PSA in a blood sample is not necessarily due to prostate cancer but could also be elevated by other conditions such as cystitis or an enlarged benign prostate. Even if the further examinations at a urology department in a hospital finds prostate cancer in the patient it is potentially indolent cancer and not a clinically important tumor which is an prostate cancer overdiagnosis and could lead to unnecessary treatment which is overtreatment. The treatment of prostate cancer could cause harms such as impotence, incontinence and faecal incontinence.
Since 2018, GP's in Denmark has been encouraged to cluster in groups of other GP's from their local area to work with quality development and form so called quality clusters. The aim of these quality clusters was to create a medical professional forum where the GP's could meet 2-4 times a year and exchange experiences with each other in a specific clinically relevant area decided by the cluster itself. One of the main points of the quality cluster concept was that the quality development work should be based on descriptive data from their own GP clinics. At present 116 quality clusters exist in Denmark and includes 3.519 GP's in 1.542 GP clinics.
By the same time of the establishment of the quality cluster a national organization called KiAP (a Danish acronym for Quality in General Practice) was founded. The primary purpose was to support the quality clusters with their quality development work. One of the supportive initiatives by KiAP is the development of cluster packages which is meeting material for the quality clusters on their cluster meetings. A cluster packages has one specific clinically relevant theme and consists of data, expert videos, reflection questions among other things.
The investigators have chosen to develop a cluster package about PSA-tests in general practice with the purpose to promote an evidence-based practice. A pilot study will be conducted in the development process. The aim of the study is to evaluate the effectiveness of the cluster package. Since the study is a cluster randomized trial the investigators invited all the Danish quality clusters to agree to use the cluster package on one of their cluster meetings. The participating quality clusters are randomized to an intervention group and a control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a cluster randomized trial. The quality clusters are the participants (clusters) and randomization will take place at quality cluster level. Each cluster includes on average 13 GP clinics. The control group will be offered the intervention at the end of the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Cluster package intervention group | Experimental | Behavioral: Podcast, Behavioral: Cluster meeting, Behavioral: Hand-out material 1, Behavioral: Hand-out material 2The intervention consists of: * A pre-recorded podcast to be heard by the GP's prior to the cluster meeting. * A two-hour meeting with a specific slideshow about PSA, data from the clinics within the cluster, current guidelines, cases and group discussions. * Two sets of hand-outs for the GP's to use in their own clinics. The intervention group will be offered the intervention during the intervention period of six months. |
| Standard care control group | No intervention | –The control group will be offered the intervention at the end of the intervention period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Quality clusters with a cluster coordinator
- Quality clusters willing to participate in a cluster meeting with PSA as a theme in 2025.
Key exclusion criteria (3 listed)
- Quality clusters who already planned their cluster meetings in 2025.
- Quality clusters unwilling to await allocation before planning their cluster meetings in 2025.
- Quality clusters participating in the pilot study
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 |
|---|---|---|
| PodcastA pre-recorded podcast with a urologist and a GP discussing the theme to promote preparatory reflections among the GPs before the cluster meeting | Behavioural | Cluster package intervention group |
| Cluster meetingA two-hour meeting facilitated by either the GPs cluster coordinator, another GP from the cluster or a facilitator outside the cluster chosen by the cluster itself with specific slides about PSA in general, guidelines, expert videos, data from the clinics, cases, and group discussions | Behavioural | Cluster package intervention group |
| Hand-out material 1Hand-outs of the main take-home messages to facilitate further discussion in their respective GP offices | Behavioural | Cluster package intervention group |
| Hand-out material 2Hand-outs to be used by GP and patients to facilitate communication about the relevance of taking a PSA-test | Behavioural | Cluster package intervention group |
Primary outcome
Change of prostate specific antigen tests on unique men ≥40 taken by general practitioners
Time frame: From cluster meeting to the end of intervention period at 6 months
The primary outcome is a reduction in the prevalence of prostate specific antigen (PSA) test on unique men ≥40 taken at the level of the quality health cluster from six month pre-intervention until six months post-intervention, in the intervention group compared to the control group. The overall aim is to improve practice of evidence based medicine by general practitioners (GP's), therefore we do not attempt to remove all PSA-test taken, neither do we set a pre-defined number that needs to be achieved. However, when following Danish Guidelines for PSA-testing, only a very small proportion of males over 40 should have the test, and therefore we consider any reduction clinically relevant.
3 secondary outcomes
Pre/post intervention change
Time frame: From cluster meeting to the end of intervention period at 6 months
High-user change
Time frame: From cluster meeting to the end of intervention period at 6 months
Variance between GPs
Time frame: From cluster meeting to the end of intervention period at 6 months
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 27 Dec 2024.
- Derived from this study: PubMed 42374596Holmkjaer P, Leick C, Drivsholm T, Siersma V, Bro F, Kousgaard MB. A cluster randomized trial to evaluate the effects of a quality cluster-based intervention on the use of prostate-specific antigen test in general practice-a study protocol. Trials. 2026 Jun 29. doi: 10.1186/s13063-026-09867-1. Online ahead of print.
- 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.
Marius Brostrøm Kousgaard, Associate professor principal investigator
Center of General Practice, Department of Public Health, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podcast, Cluster meeting and Hand-out material 1 in people with Prostate Cancer and Evidence Based Medicine, run by University of Copenhagen at 1 site in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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 Denmark. 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?
Contact Christian Leick, PhD student (004560898397, christian.leick@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of prostate specific antigen tests on unique men ≥40 taken by general practitioners (time frame: From cluster meeting to the end of intervention period at 6 months). 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 NCT06748456, 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 27 Dec 2024.