Prostate CancerProCaRisNCT01739062
The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
A study testing Genetic risk assessment in people with Prostate Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Genetic risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to 30 Oct 2031
- 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 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who receive a PSA test
Who cannot join
- age over 80 years
- elevated PSA-level (> 4,0 ng/ml) concurrently or within previous 2 years
- prostate or bladder disease
- prostate cancer
- non-Caucasians
- do not speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.
- Conditions
- Prostate Cancer
- Being tested
- Genetic risk assessment
- Keywords
- PSA test, Prostate cancer, Genetic screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic risk assessmentGenetic
Also called Single nucleotide polymorphism
| Study group | Role | What they receive |
|---|---|---|
| Genetic risk assessment | Experimental | At least 40 SNP (single nucleotide polymorphisms)increase the risk of PCa. The individual risk of PCa accumulates with the increasing number of these genetic variants. The risk is doubled if patient has familial disposition as well. In retrospective studies, non-genetic risk-prediction models were compared to risk-prediction models containing both non-genetic factors and SNPs analyses. The genetic models had a significantly higher specificity than the non-genetic models. It has been argued that genetic PCa risk assessment could reduce the inexpedient use of PSA tests, saving it for patients at high risk of PCa. Receives: Genetic: Genetic risk assessment |
| Familial disposition risk assessment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of low risk patients who get a PSA test
The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice.
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 University of AarhusThe 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
- None (open label)
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Karina D Sørensen, PhD, Principal investigator, Department of Molecular Medicine, Aarhus University Hospital, DenmarkFlemming Bro, Professor, Study chair, The Research Unit for General Practice, Aarhus University, DenmarkPeter Vedsted, Professor, Study chair, Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739062
- Sponsor's protocol ID
- 2011-41-6904
- Acronym
- ProCaRis
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2012
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fredsoe J, Kirkegaard P, Edwards A, Vedsted P, Sorensen KD, Bro F. A genetic risk assessment for prostate cancer influences patients' risk perception and use of repeat PSA testing: a cross-sectional study in Danish general practice. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101039. doi: 10.3399/bjgpopen20X101039. Print 2020.
PubMed 32457098Fredsoe J, Koetsenruyter J, Vedsted P, Kirkegaard P, Vaeth M, Edwards A, Orntoft TF, Sorensen KD, Bro F. The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial. PLoS Med. 2020 Feb 7;17(2):e1003033. doi: 10.1371/journal.pmed.1003033. eCollection 2020 Feb.
PubMed 32032355Kirkegaard P, Edwards A, Nielsen TLO, Orntoft TF, Sorensen KD, Borre M, Bro F. Perceptions about screening for prostate cancer using genetic lifetime risk assessment: a qualitative study. BMC Fam Pract. 2018 Feb 17;19(1):32. doi: 10.1186/s12875-018-0717-6.
PubMed 29454309Kirkegaard P, Vedsted P, Edwards A, Fenger-Gron M, Bro F. A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice--the ProCaRis study: study protocol. BMJ Open. 2013 Mar 1;3(3):e002452. doi: 10.1136/bmjopen-2012-002452.
PubMed 23457331
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
- ClinicalTrials.gov ID
- NCT01739062
- Acronym / sponsor ID
- ProCaRis / 2011-41-6904
- Conditions
- Prostate Cancer
- Keywords
- PSA test, Prostate cancer, Genetic screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Velux Fonden, Aarhus University Hospital
- Study start
- Feb 2013 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 30 Nov 2012 (estimated)
- 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 preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic risk assessment | Experimental | Genetic: Genetic risk assessmentAt least 40 SNP (single nucleotide polymorphisms)increase the risk of PCa. The individual risk of PCa accumulates with the increasing number of these genetic variants. The risk is doubled if patient has familial disposition as well. In retrospective studies, non-genetic risk-prediction models were compared to risk-prediction models containing both non-genetic factors and SNPs analyses. The genetic models had a significantly higher specificity than the non-genetic models. It has been argued that genetic PCa risk assessment could reduce the inexpedient use of PSA tests, saving it for patients at high risk of PCa. |
| Familial disposition risk assessment | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who receive a PSA test
Key exclusion criteria (6 listed)
- age over 80 years
- elevated PSA-level (> 4,0 ng/ml) concurrently or within previous 2 years
- prostate or bladder disease
- prostate cancer
- non-Caucasians
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 |
|---|---|---|
| Genetic risk assessmentAlso: Single nucleotide polymorphism | Genetic | Genetic risk assessment |
Primary outcome
Number of low risk patients who get a PSA test
Time frame: 1 year, 2 years
The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice.
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 Dec 2023.
- Background: PubMed 32457098Fredsoe J, Kirkegaard P, Edwards A, Vedsted P, Sorensen KD, Bro F. A genetic risk assessment for prostate cancer influences patients' risk perception and use of repeat PSA testing: a cross-sectional study in Danish general practice. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101039. doi: 10.3399/bjgpopen20X101039. Print 2020.
- Background: PubMed 32032355Fredsoe J, Koetsenruyter J, Vedsted P, Kirkegaard P, Vaeth M, Edwards A, Orntoft TF, Sorensen KD, Bro F. The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial. PLoS Med. 2020 Feb 7;17(2):e1003033. doi: 10.1371/journal.pmed.1003033. eCollection 2020 Feb.
- Background: PubMed 29454309Kirkegaard P, Edwards A, Nielsen TLO, Orntoft TF, Sorensen KD, Borre M, Bro F. Perceptions about screening for prostate cancer using genetic lifetime risk assessment: a qualitative study. BMC Fam Pract. 2018 Feb 17;19(1):32. doi: 10.1186/s12875-018-0717-6.
- Derived from this study: PubMed 23457331Kirkegaard P, Vedsted P, Edwards A, Fenger-Gron M, Bro F. A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice--the ProCaRis study: study protocol. BMJ Open. 2013 Mar 1;3(3):e002452. doi: 10.1136/bmjopen-2012-002452.
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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.
Karina D Sørensen, PhD principal investigator
Department of Molecular Medicine, Aarhus University Hospital, Denmark
Flemming Bro, Professor study chair
The Research Unit for General Practice, Aarhus University, Denmark
Peter Vedsted, Professor study chair
Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic risk assessment in people with Prostate Cancer, run by University of Aarhus 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 1 inclusion and 6 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 Dec 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 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?
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?
Number of low risk patients who get a PSA test (time frame: 1 year, 2 years). 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 NCT01739062, which also lists 4 linked publications.
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 Dec 2023.