Prostate CancerNCT02831920
CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
A study testing CEUS and targeted biopsies and MRI and targeted biopsies in people with Prostate Cancer and Prostatic Neoplasms, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- CEUS and targeted biopsies and MRI and targeted biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Dec 2015to Dec 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- signed informed consent
- referred for mpMRI and primary biopsy
Who cannot join
- Documented acute prostatitis or urinary tract infections
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has received a biopsy procedure within 30 days before admission into this study
- Has received a biopsy procedure at the Academic Medical Center within a year before admission into this study
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AMC University Hospital
Amsterdam, 1105 AZ
H. Wijkstra, Prof.Dr.Ir., +31 20 5666379, h.wijkstra@amc.uva.nl
About this study
The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy targeting, but the value in biopsy naive patients remains controversial. With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. To overcome these difficulties CEUS quantification techniques have been used with encouraging first results. These imaging techniques have been proposed to improve the yield of prostate biopsies and possibly replacing systematic biopsies.
In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy. Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS lesions, together with standard systematic biopsies in the same patients by separate blinded clinicians. The main outcome measure is the per-patient (significant) prostate cancer detection rate for each of the biopsy regimens.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- CEUS and targeted biopsies, MRI and targeted biopsies
- Keywords
- Prostate Cancer, MRI, CEUS, Contrast Ultrasound, Fusion, targeted biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS and targeted biopsiesOther
MRI and targeted biopsiesOther
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control. Receives: Other: CEUS and targeted biopsies; Other: MRI and targeted biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies
Measured: 2 weeks
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies
Measured: 2 weeks
per-patient (significant) prostate cancer detection rate of systematic biopsies
Measured: 2 weeks
Secondary outcomes (1)
complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start7 Dec 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 299 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Hessel H. Wijkstra, Prof dr ir, Principal investigator, AMC University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831920
- Sponsor's protocol ID
- METC 2015_263
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Butler MB, Papageorgiou G, Kanoulas ED, Voulgaridou V, Wijkstra H, Mischi M, Mannaerts CK, McDougall S, Duncan WC, Lu W, Sboros V. Mapping of prostate cancer microvascular patterns using super-resolution ultrasound imaging. Eur Radiol Exp. 2025 Feb 20;9(1):25. doi: 10.1186/s41747-025-00561-6.
PubMed 39976631Postema AW, Scheltema MJ, Mannaerts CK, Van Sloun RJ, Idzenga T, Mischi M, Engelbrecht MR, De la Rosette JJ, Wijkstra H. The prostate cancer detection rates of CEUS-targeted versus MRI-targeted versus systematic TRUS-guided biopsies in biopsy-naive men: a prospective, comparative clinical trial using the same patients. BMC Urol. 2017 Apr 5;17(1):27. doi: 10.1186/s12894-017-0213-7.
PubMed 28381220
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02831920
- Acronym / sponsor ID
- METC 2015_263
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Prostate Cancer, MRI, CEUS, Contrast Ultrasound, Fusion, targeted biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 299 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Jul 2016 (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 current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy targeting, but the value in biopsy naive patients remains controversial. With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. To overcome these difficulties CEUS quantification techniques have been used with encouraging first results. These imaging techniques have been proposed to improve the yield of prostate biopsies and possibly replacing systematic biopsies.
In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy. Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS lesions, together with standard systematic biopsies in the same patients by separate blinded clinicians. The main outcome measure is the per-patient (significant) prostate cancer detection rate for each of the biopsy regimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: CEUS and targeted biopsies, Other: MRI and targeted biopsiesevery patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- signed informed consent
- referred for mpMRI and primary biopsy
Key exclusion criteria (8 listed)
- Documented acute prostatitis or urinary tract infections
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has received a biopsy procedure within 30 days before admission into this 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 |
|---|---|---|
| CEUS and targeted biopsies | Other | Single Arm |
| MRI and targeted biopsies | Other | Single Arm |
Primary outcome
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies
Time frame: 2 weeks
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies
Time frame: 2 weeks
per-patient (significant) prostate cancer detection rate of systematic biopsies
Time frame: 2 weeks
1 secondary outcome
complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Derived from this study: PubMed 39976631Butler MB, Papageorgiou G, Kanoulas ED, Voulgaridou V, Wijkstra H, Mischi M, Mannaerts CK, McDougall S, Duncan WC, Lu W, Sboros V. Mapping of prostate cancer microvascular patterns using super-resolution ultrasound imaging. Eur Radiol Exp. 2025 Feb 20;9(1):25. doi: 10.1186/s41747-025-00561-6.
- Derived from this study: PubMed 28381220Postema AW, Scheltema MJ, Mannaerts CK, Van Sloun RJ, Idzenga T, Mischi M, Engelbrecht MR, De la Rosette JJ, Wijkstra H. The prostate cancer detection rates of CEUS-targeted versus MRI-targeted versus systematic TRUS-guided biopsies in biopsy-naive men: a prospective, comparative clinical trial using the same patients. BMC Urol. 2017 Apr 5;17(1):27. doi: 10.1186/s12894-017-0213-7.
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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.
Hessel H. Wijkstra, Prof dr ir principal investigator
AMC 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 CEUS and targeted biopsies and MRI and targeted biopsies in people with Prostate Cancer and Prostatic Neoplasms, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 8 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 17 Jan 2019. 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 Netherlands. 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?
Contact Hessel H. Wijkstra, Prof dr ir (+31 20 5666379, h.wijkstra@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 NCT02831920, which also lists 2 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 17 Jan 2019.