Prostate CancerNCT03431753
Early and Accurate Detection of Prostate Cancer in General Practice
A study testing PSA, STHLM3 and mpMRI for PC detection in people with Prostate Cancer and Prostate Neoplasm, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided… Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma
- What is being tested?
- PSA, STHLM3 and mpMRI for PC detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- 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 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 50-69 years
- no previous pelvic cancer
- no previous prostate biopsy
- no previous elevated PSA results
- informed consent from the participant
Who cannot join
- palpable prostatae tumor by digital rectal examination
- previously diagnosed with/or treated for an urogenital cancer disease
- contraindications to 3 T MRI
- known severe renal impairment with estimated glomerular filtration rate <30 ml / min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.
Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy.
This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.
Read the detailed description
While early stage PC can be cured by surgery or radiation therapy, advanced PC is incurable and associated with high morbidity and mortality. Early detection is critical to save lives, but many newly diagnosed PCs are in reality non-aggressive and will not affect the patient's life or health, even if left untreated. There is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive PC while curable, reduce unnecessary prostate biopsies incl. risk of sepsis and reduce overdiagnosis/-treatment of indolent PC.
New molecular biomarkers applied in general practice, serving as a pre-selection test for follow-up, and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems.
In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers (STHLM3 test) in general practice with mpMRI and MR-guided in bore biopsy (MRGB) for early PC detection in a biopsy naïve population.
- Conditions
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma
- Being tested
- PSA, STHLM3 and mpMRI for PC detection
- Keywords
- STHLM3-test, prostate cancer, MR-imaging, MR-targeted biopsy, MRI, Novel biomarkers, 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.
PSA, STHLM3 and mpMRI for PC detectionDiagnostic test
Men who request a prostate specific antigen test from their general practitioner will be offered study participation.
Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination.
| Study group | Role | What they receive |
|---|---|---|
| PSA, STHLM3 and mpMRI for PC detection | Experimental | mpMRI, and if suspect MR-targeted prostate biopsy, in men with increased PC risk as judged from the STHLM3 test and/or an elevated prostate specific antigen test. Receives: Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test.
Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.
Measured: 24 months
Secondary outcomes (2)
Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test.
Evaluation of the proportion of total PCs and clinically significant PCs diagnosed with MR guided biopsy as a function of the primary tests.
Measured: 24 months
Compare results from clinical study with current clinical practice.
Comparison of the results from the clinical study with the number of prostate specific antigen tests, TRUS-biopsies, indolent and significant PCs detected by current clinical practice, using health register data from general practices not taking part in the trial.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Hospital Holstebro, University of Aarhus, Central Denmark Region, Karolinska Institutet, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Bodil G. Pedersen, MD, PhD, Principal investigator, Department of Radiology, Aarhus University HospitalKarina D. Sørensen, Professor, Principal investigator, Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431753
- Sponsor's protocol ID
- PRIMA
- Status last verified
- Oct 2020
- First submitted
- 21 Dec 2017
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.
- ClinicalTrials.gov ID
- NCT03431753
- Acronym / sponsor ID
- PRIMA
- Conditions
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma
- Keywords
- STHLM3-test, prostate cancer, MR-imaging, MR-targeted biopsy, MRI, Novel biomarkers, Genetic screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Regional Hospital Holstebro, University of Aarhus, Central Denmark Region, Karolinska Institutet, Karolinska University Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Feb 2018 (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.
Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy.
This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.
Detailed description
While early stage PC can be cured by surgery or radiation therapy, advanced PC is incurable and associated with high morbidity and mortality. Early detection is critical to save lives, but many newly diagnosed PCs are in reality non-aggressive and will not affect the patient's life or health, even if left untreated. There is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive PC while curable, reduce unnecessary prostate biopsies incl. risk of sepsis and reduce overdiagnosis/-treatment of indolent PC.
New molecular biomarkers applied in general practice, serving as a pre-selection test for follow-up, and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems.
In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers (STHLM3 test) in general practice with mpMRI and MR-guided in bore biopsy (MRGB) for early PC detection in a biopsy naïve population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSA, STHLM3 and mpMRI for PC detection | Experimental | Diagnostic Test: PSA, STHLM3 and mpMRI for PC detectionmpMRI, and if suspect MR-targeted prostate biopsy, in men with increased PC risk as judged from the STHLM3 test and/or an elevated prostate specific antigen test. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 50-69 years
- no previous pelvic cancer
- no previous prostate biopsy
- no previous elevated PSA results
- informed consent from the participant
Key exclusion criteria (4 listed)
- palpable prostatae tumor by digital rectal examination
- previously diagnosed with/or treated for an urogenital cancer disease
- contraindications to 3 T MRI
- known severe renal impairment with estimated glomerular filtration rate <30 ml / min
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, STHLM3 and mpMRI for PC detectionMen who request a prostate specific antigen test from their general practitioner will be offered study participation. Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination. | Diagnostic test | PSA, STHLM3 and mpMRI for PC detection |
Primary outcome
Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test.
Time frame: 24 months
Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.
2 secondary outcomes
Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test.
Time frame: 24 months
Compare results from clinical study with current clinical practice.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- 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.
Bodil G. Pedersen, MD, PhD principal investigator
Department of Radiology, Aarhus University Hospital
Karina D. Sørensen, Professor principal investigator
Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA, STHLM3 and mpMRI for PC detection in people with Prostate Cancer and Prostate Neoplasm, run by Aarhus University Hospital 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 May 2021. 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?
Results are not available in the source record.
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?
Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2021.