Prostate CancerPROFUSENCT02450266
Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
A study testing Systematic transrectal ultrasound-guided prostate biopsy and MRI/ultrasound fusion-guided prostate biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
Trial summary
Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Systematic transrectal ultrasound-guided prostate biopsy and MRI/ultrasound fusion-guided prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2015to Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one negative transrectal ultrasound-guided prostate biopsy
- PSA > 3.0 ng/ml or PSA velocity >0.75 ng/ml/p.a.
Who cannot join
- Known prostate cancer
- PSA >50 ng/ml
- Previous MRI-targeted prostate biopsy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Department of Urology, Charité-Universitätsmedizin
Berlin, 12200
Kurt Miller, MD, +49 30 8445 2575
- Recruiting
Department of Urology, University Hospital Düsseldorf
Düsseldorf, 40225
Christian Arsov, MD, +49 211 8108607, christian.arsov@med.uni-duesseldorf.de
- Recruiting
Department of Urology, University Hospital Jena
Jena, 07743
Marc O Grimm, MD, +49 3641-935206
About this study
Official title: Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy
Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings.
Read the detailed description
In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy.
Men with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated PSA values (> 3 ng/ml) or PSA velocity >0.75 ng/ml/p.a. will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound--guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI/ultrasound fusion-guided.
- Conditions
- Prostate Cancer
- Being tested
- Systematic transrectal ultrasound-guided prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy
- Keywords
- Primary disease, multiparametric MRI, targeted prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy, systematic transrectal ultrasound-guided prostate 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.
Systematic transrectal ultrasound-guided prostate biopsyDevice
12-18 systematic biopsy cores
MRI/ultrasound fusion-guided prostate biopsyDevice
2 targeted biopsy cores from each prostate lesion
| Study group | Role | What they receive |
|---|---|---|
| A: Transrectal ultrasound-guided biopsy | Active comparator | Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume) Receives: Device: Systematic transrectal ultrasound-guided prostate biopsy |
| B: MRI/ultrasound fusion-guided biopsy | Experimental | Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Receives: Device: MRI/ultrasound fusion-guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of significant prostate cancers
Measured: One week after biopsy
Secondary outcomes (1)
Overall detection rate of prostate cancers
Measured: One week after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (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 Heinrich-Heine University, DuesseldorfThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Christian Arsov, MD, Principal investigator, Department of Urology, University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450266
- Sponsor's protocol ID
- 004
- Acronym
- PROFUSE
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy
- ClinicalTrials.gov ID
- NCT02450266
- Acronym / sponsor ID
- PROFUSE / 004
- Conditions
- Prostate Cancer
- Keywords
- Primary disease, multiparametric MRI, targeted prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy, systematic transrectal ultrasound-guided prostate biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 586 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 21 May 2015 (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.
Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings.
Detailed description
In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy.
Men with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated PSA values (> 3 ng/ml) or PSA velocity >0.75 ng/ml/p.a. will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound--guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI/ultrasound fusion-guided.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Transrectal ultrasound-guided biopsy | Active comparator | Device: Systematic transrectal ultrasound-guided prostate biopsyPatients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume) |
| B: MRI/ultrasound fusion-guided biopsy | Experimental | Device: MRI/ultrasound fusion-guided prostate biopsyPatients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one negative transrectal ultrasound-guided prostate biopsy
- PSA > 3.0 ng/ml or PSA velocity >0.75 ng/ml/p.a.
Key exclusion criteria (3 listed)
- Known prostate cancer
- PSA >50 ng/ml
- Previous MRI-targeted prostate biopsy
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 |
|---|---|---|
| Systematic transrectal ultrasound-guided prostate biopsy12-18 systematic biopsy cores | Device | A: Transrectal ultrasound-guided biopsy |
| MRI/ultrasound fusion-guided prostate biopsy2 targeted biopsy cores from each prostate lesion | Device | B: MRI/ultrasound fusion-guided biopsy |
Primary outcome
Detection rate of significant prostate cancers
Time frame: One week after biopsy
1 secondary outcome
Overall detection rate of prostate cancers
Time frame: One week after biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Christian Arsov, MD principal investigator
Department of Urology, University Hospital Düsseldorf
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic transrectal ultrasound-guided prostate biopsy and MRI/ultrasound fusion-guided prostate biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
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: status not confirmed, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 Christian Arsov, MD (+49 211 8108607, christian.arsov@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of significant prostate cancers (time frame: One week after biopsy). 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 21 May 2015.