Prostate CancerProBioMNCT03730324
Predicting Prostate Biopsy Results With Biomarkers and mpMRI.
A study testing mpMRI and Urine and plasma biomarkes. in people with Prostate Cancer, run by Torben Brøchner Pedersen at 1 site in Denmark.
Trial summary
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mpMRI and Urine and plasma biomarkes.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Nov 2018to 1 Jun 2022
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed written consent.
- PSA < 20.
- Referred for prostate biopsy.
Who cannot join
- Previously diagnosed with prostate cancer.
- Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies.
- Previously undergone prostate biopsies.
- Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc)
- Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers).
- They withdraw their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement.
In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.
Read the detailed description
Background Prostate cancer (PC) remains a significant cause of morbidity and death among men in Denmark and the rest of the western world. Over 4,500 PC cases are diagnosed every year being the second most common malignancy among men in Denmark. With increasing life expectancy, the incidence of PC is projected to increase. Pivotal to the successful treatment of prostate cancer is establishing an early diagnosis. Localised PC is potentially curable and current curative treatment options have shown efficacy in reducing cancer related mortality.
TRUS biopsies:
Transrectal ultrasound guided prostate biopsies (TRUS biopsies) are conducted routinely for histopathological confirmation in cases of suspected PC. Indication for prostate biopsies include elevated Prostate Specific Antigen (PSA) levels or palpable tumour on digital rectal examination. TRUS biopsies is associated with morbidity in the form of infection, haematuria, rectal bleeding and discomfort. Some of these complications may require hospital admission and can be life threatening.
Current standard biopsy regimes include 10 to 14 systemic biopsy cores taken from the peripheral zone of the prostate. The majority of PC involve the posterior peripheral zone of the prostate readily available for biopsies. The remaining PC are isolated to the transition-, central- and anterior zone of the prostate which are not routinely biopsied on systemic biopsies. Thus, anteriorly located cancers may not be sampled with routine investigations and TRUS biopsies may yield false negative results. As the biopsies are taken randomly throughout the gland, significant cancers located in the peripheral zone will in some cases be missed.
Biomarkers and liquid biopsies:
PSA testing has been widely adopted and more cancers are being detected in Denmark due to unsystematic screening with PSA. PSA is a glycoprotein of the human kallikrein family, and elevated serum concentrations are associated to PC. It is organ specific but not cancer specific, therefore other causes may elevate values, including benign prostatic hyperplasia, prostatitis, urinary tract infections and bladder outlet obstruction. To distinguish prostate cancer from other causes of PSA elevation and to confirm the diagnosis, TRUS biopsies are currently the standard diagnostic test.
A range of novel biomarkers has been proposed to overcome the limitations of PSA's low specificity. Few of these biomarkers have been implemented in clinical practise. In a recently published study, Albitar et al, using a panel of urine and plasma biomarkers, where able to predict biopsy outcomes with a positive predictive value of 90% and negative predictive value of 89% tolerating some low grade cancers (Gleason score < 7). This idea has been disseminated as liquid biopsies.
mpMRI of the prostate: Multiparametric magnetic resonance imaging (mpMRI) of the prostate has emerged as a new technology with the ability to detect PC. Especially in the setting of previously negative TRUS biopsies, mpMRI can provide important additional information enabling targeting of biopsies towards suspected PC lesions. Nevertheless, a PC negative mpMRI may fail to detect cancers in 43% of cases and miss 16% of PCs classified as clinical significant. Thus a negative mpMRI will currently still mandate systemic biopsies. Therefore, novel approaches are needed to better direct biopsies and select patient for biopsies.
Aim
The aim of the current project is to study the following issues:
Assessing the value of prebiopsy mpMRI combined with liquid biopsies in biopsy naive men in predicting biopsy results and possible deriving a diagnostic predictive model.
Assessment of the performance of TRUS mpMRI fusion guided biopsies vs. systemic biopsies combined with liquid biopsies.
Confirming the value of liquid biopsies and investigating its relation to tumour grade and volume.
- Conditions
- Prostate Cancer
- Being tested
- mpMRI, Urine and plasma biomarkes.
- Keywords
- Biomarkers, Magnetic Resonance Imaging, Diagnostic
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRIDiagnostic test
Study subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy
Urine and plasma biomarkes.Diagnostic test
Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Study subject will undergo sampling of plasma and urine biomarkers. Receives: Diagnostic Test: Urine and plasma biomarkes. |
| Magnetic Resonance Imaging. | Experimental | Prior to biopsies a magnetic resonance imaging scan will be performed. Receives: Diagnostic Test: mpMRI; Diagnostic Test: Urine and plasma biomarkes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of clinical significant cancer.
Positive biopsies with a Gleason grade > 7.
Measured: 1 month
Secondary outcomes (1)
Detection rate of any cancers
Positive biopsies, any Gleason grade.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start5 Nov 2018
- Primary completion1 Jul 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subjects will be randomized in a 1:7 fashion between 1. Standard biopsies + biomarkers and 2. Biomarkers + mpMRI and Standard / mpMRI targeted biopsies.
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torben Brøchner Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Torben Brøchner Pedersen, Odense University Hospital
- Investigators
- Lars Lund, DMsc, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730324
- Sponsor's protocol ID
- S-20170043
- Acronym
- ProBioM
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2018
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nye kræfttilfælde Tabel [Internet]. Danish Cancer Registry - eSundhed. 2016
Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.
PubMed 24597866Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
PubMed 27568654Pelzer AE, Bektic J, Berger AP, Halpern EJ, Koppelstatter F, Klauser A, Rehder P, Horninger W, Bartsch G, Frauscher F. Are transition zone biopsies still necessary to improve prostate cancer detection? Results from the tyrol screening project. Eur Urol. 2005 Dec;48(6):916-21; discussion 921. doi: 10.1016/j.eururo.2005.07.012. Epub 2005 Aug 10.
PubMed 16126324Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med. 1987 Oct 8;317(15):909-16. doi: 10.1056/NEJM198710083171501.
PubMed 2442609Albitar M, Ma W, Lund L, Albitar F, Diep K, Fritsche HA, Shore N. Predicting Prostate Biopsy Results Using a Panel of Plasma and Urine Biomarkers Combined in a Scoring System. J Cancer. 2016 Feb 2;7(3):297-303. doi: 10.7150/jca.12771. eCollection 2016.
PubMed 26918043Panebianco V, Barchetti F, Sciarra A, Ciardi A, Indino EL, Papalia R, Gallucci M, Tombolini V, Gentile V, Catalano C. Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol. 2015 Jan;33(1):17.e1-17.e7. doi: 10.1016/j.urolonc.2014.09.013. Epub 2014 Nov 11.
PubMed 25443268Turkbey B, Pinto PA, Mani H, Bernardo M, Pang Y, McKinney YL, Khurana K, Ravizzini GC, Albert PS, Merino MJ, Choyke PL. Prostate cancer: value of multiparametric MR imaging at 3 T for detection--histopathologic correlation. Radiology. 2010 Apr;255(1):89-99. doi: 10.1148/radiol.09090475.
PubMed 20308447Boesen L, Noergaard N, Chabanova E, Logager V, Balslev I, Mikines K, Thomsen HS. Early experience with multiparametric magnetic resonance imaging-targeted biopsies under visual transrectal ultrasound guidance in patients suspicious for prostate cancer undergoing repeated biopsy. Scand J Urol. 2015 Feb;49(1):25-34. doi: 10.3109/21681805.2014.925497. Epub 2014 Jun 12.
PubMed 24922550Filson CP, Natarajan S, Margolis DJ, Huang J, Lieu P, Dorey FJ, Reiter RE, Marks LS. Prostate cancer detection with magnetic resonance-ultrasound fusion biopsy: The role of systematic and targeted biopsies. Cancer. 2016 Mar 15;122(6):884-92. doi: 10.1002/cncr.29874. Epub 2016 Jan 7.
PubMed 26749141Lamb BW, Tan WS, Rehman A, Nessa A, Cohen D, O'Neil J, Green JS, Hines JE. Is Prebiopsy MRI Good Enough to Avoid Prostate Biopsy? A Cohort Study Over a 1-Year Period. Clin Genitourin Cancer. 2015 Dec;13(6):512-7. doi: 10.1016/j.clgc.2015.06.007. Epub 2015 Jun 30.
PubMed 26231912
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.
- ClinicalTrials.gov ID
- NCT03730324
- Acronym / sponsor ID
- ProBioM / S-20170043
- Conditions
- Prostate Cancer
- Keywords
- Biomarkers, Magnetic Resonance Imaging, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Torben Brøchner PedersenUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Nov 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.
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement.
In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.
Detailed description
Background Prostate cancer (PC) remains a significant cause of morbidity and death among men in Denmark and the rest of the western world. Over 4,500 PC cases are diagnosed every year being the second most common malignancy among men in Denmark. With increasing life expectancy, the incidence of PC is projected to increase. Pivotal to the successful treatment of prostate cancer is establishing an early diagnosis. Localised PC is potentially curable and current curative treatment options have shown efficacy in reducing cancer related mortality.
TRUS biopsies:
Transrectal ultrasound guided prostate biopsies (TRUS biopsies) are conducted routinely for histopathological confirmation in cases of suspected PC. Indication for prostate biopsies include elevated Prostate Specific Antigen (PSA) levels or palpable tumour on digital rectal examination. TRUS biopsies is associated with morbidity in the form of infection, haematuria, rectal bleeding and discomfort. Some of these complications may require hospital admission and can be life threatening.
Current standard biopsy regimes include 10 to 14 systemic biopsy cores taken from the peripheral zone of the prostate. The majority of PC involve the posterior peripheral zone of the prostate readily available for biopsies. The remaining PC are isolated to the transition-, central- and anterior zone of the prostate which are not routinely biopsied on systemic biopsies. Thus, anteriorly located cancers may not be sampled with routine investigations and TRUS biopsies may yield false negative results. As the biopsies are taken randomly throughout the gland, significant cancers located in the peripheral zone will in some cases be missed.
Biomarkers and liquid biopsies:
PSA testing has been widely adopted and more cancers are being detected in Denmark due to unsystematic screening with PSA. PSA is a glycoprotein of the human kallikrein family, and elevated serum concentrations are associated to PC. It is organ specific but not cancer specific, therefore other causes may elevate values, including benign prostatic hyperplasia, prostatitis, urinary tract infections and bladder outlet obstruction. To distinguish prostate cancer from other causes of PSA elevation and to confirm the diagnosis, TRUS biopsies are currently the standard diagnostic test.
A range of novel biomarkers has been proposed to overcome the limitations of PSA's low specificity. Few of these biomarkers have been implemented in clinical practise. In a recently published study, Albitar et al, using a panel of urine and plasma biomarkers, where able to predict biopsy outcomes with a positive predictive value of 90% and negative predictive value of 89% tolerating some low grade cancers (Gleason score < 7). This idea has been disseminated as liquid biopsies.
mpMRI of the prostate: Multiparametric magnetic resonance imaging (mpMRI) of the prostate has emerged as a new technology with the ability to detect PC. Especially in the setting of previously negative TRUS biopsies, mpMRI can provide important additional information enabling targeting of biopsies towards suspected PC lesions. Nevertheless, a PC negative mpMRI may fail to detect cancers in 43% of cases and miss 16% of PCs classified as clinical significant. Thus a negative mpMRI will currently still mandate systemic biopsies. Therefore, novel approaches are needed to better direct biopsies and select patient for biopsies.
Aim
The aim of the current project is to study the following issues:
Assessing the value of prebiopsy mpMRI combined with liquid biopsies in biopsy naive men in predicting biopsy results and possible deriving a diagnostic predictive model.
Assessment of the performance of TRUS mpMRI fusion guided biopsies vs. systemic biopsies combined with liquid biopsies.
Confirming the value of liquid biopsies and investigating its relation to tumour grade and volume.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study subjects will be randomized in a 1:7 fashion between 1. Standard biopsies + biomarkers and 2. Biomarkers + mpMRI and Standard / mpMRI targeted biopsies.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Diagnostic Test: Urine and plasma biomarkes.Study subject will undergo sampling of plasma and urine biomarkers. |
| Magnetic Resonance Imaging. | Experimental | Diagnostic Test: mpMRI, Diagnostic Test: Urine and plasma biomarkes.Prior to biopsies a magnetic resonance imaging scan will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide informed written consent.
- PSA < 20.
- Referred for prostate biopsy.
Key exclusion criteria (6 listed)
- Previously diagnosed with prostate cancer.
- Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies.
- Previously undergone prostate biopsies.
- Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc)
- Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers).
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 |
|---|---|---|
| mpMRIStudy subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy | Diagnostic test | Magnetic Resonance Imaging. |
| Urine and plasma biomarkes.Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy | Diagnostic test | Magnetic Resonance Imaging., Standard care |
Primary outcome
Detection of clinical significant cancer.
Time frame: 1 month
Positive biopsies with a Gleason grade > 7.
1 secondary outcome
Detection rate of any cancers
Time frame: 1 month
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 20 Oct 2026.
- BackgroundNye kræfttilfælde Tabel [Internet]. Danish Cancer Registry - eSundhed. 2016
- Background: PubMed 24597866Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.
- Background: PubMed 27568654Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
- Background: PubMed 16126324Pelzer AE, Bektic J, Berger AP, Halpern EJ, Koppelstatter F, Klauser A, Rehder P, Horninger W, Bartsch G, Frauscher F. Are transition zone biopsies still necessary to improve prostate cancer detection? Results from the tyrol screening project. Eur Urol. 2005 Dec;48(6):916-21; discussion 921. doi: 10.1016/j.eururo.2005.07.012. Epub 2005 Aug 10.
- Background: PubMed 2442609Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med. 1987 Oct 8;317(15):909-16. doi: 10.1056/NEJM198710083171501.
- Background: PubMed 26918043Albitar M, Ma W, Lund L, Albitar F, Diep K, Fritsche HA, Shore N. Predicting Prostate Biopsy Results Using a Panel of Plasma and Urine Biomarkers Combined in a Scoring System. J Cancer. 2016 Feb 2;7(3):297-303. doi: 10.7150/jca.12771. eCollection 2016.
- Background: PubMed 25443268Panebianco V, Barchetti F, Sciarra A, Ciardi A, Indino EL, Papalia R, Gallucci M, Tombolini V, Gentile V, Catalano C. Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol. 2015 Jan;33(1):17.e1-17.e7. doi: 10.1016/j.urolonc.2014.09.013. Epub 2014 Nov 11.
- Background: PubMed 20308447Turkbey B, Pinto PA, Mani H, Bernardo M, Pang Y, McKinney YL, Khurana K, Ravizzini GC, Albert PS, Merino MJ, Choyke PL. Prostate cancer: value of multiparametric MR imaging at 3 T for detection--histopathologic correlation. Radiology. 2010 Apr;255(1):89-99. doi: 10.1148/radiol.09090475.
- Background: PubMed 24922550Boesen L, Noergaard N, Chabanova E, Logager V, Balslev I, Mikines K, Thomsen HS. Early experience with multiparametric magnetic resonance imaging-targeted biopsies under visual transrectal ultrasound guidance in patients suspicious for prostate cancer undergoing repeated biopsy. Scand J Urol. 2015 Feb;49(1):25-34. doi: 10.3109/21681805.2014.925497. Epub 2014 Jun 12.
- Background: PubMed 26749141Filson CP, Natarajan S, Margolis DJ, Huang J, Lieu P, Dorey FJ, Reiter RE, Marks LS. Prostate cancer detection with magnetic resonance-ultrasound fusion biopsy: The role of systematic and targeted biopsies. Cancer. 2016 Mar 15;122(6):884-92. doi: 10.1002/cncr.29874. Epub 2016 Jan 7.
- Background: PubMed 26231912Lamb BW, Tan WS, Rehman A, Nessa A, Cohen D, O'Neil J, Green JS, Hines JE. Is Prebiopsy MRI Good Enough to Avoid Prostate Biopsy? A Cohort Study Over a 1-Year Period. Clin Genitourin Cancer. 2015 Dec;13(6):512-7. doi: 10.1016/j.clgc.2015.06.007. Epub 2015 Jun 30.
- Individual participant dataSharing planned: Undecided
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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.
Lars Lund, DMsc principal investigator
Odense 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 mpMRI and Urine and plasma biomarkes. in people with Prostate Cancer, run by Torben Brøchner Pedersen 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 3 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: finished, as of the sponsor's last update on 20 Oct 2026. 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?
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?
Detection of clinical significant cancer. (time frame: 1 month). 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 NCT03730324, which also lists 11 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 20 Oct 2026.