Prostate CancerNCT01553838
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
A study testing MRI guided prostate biopsy and TRUS guided biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml. 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?
- MRI guided prostate biopsy and TRUS guided biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Oct 2013
- 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
- PSA > 4.0 ng/ml
- written informed consent
- age >18
Who cannot join
- patients with prostate cancer
- patients with prior prostate biopsy
- patients with contraindications against MRI or biopsy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.
- Conditions
- Prostate Cancer
- Being tested
- MRI guided prostate biopsy and TRUS guided biopsy
- Keywords
- prostate biopsy, MRI guided biopsy, TRUS guided 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.
MRI guided prostate biopsy and TRUS guided biopsyDevice
MRI guided prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Sequentially MRI guided and TRUS guided biopsy | Experimental | Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy Receives: Device: MRI guided prostate biopsy and TRUS guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer detection rate
Measured: 3 years
Secondary outcomes (1)
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Arsov, MD, Principal investigator, Department of Urology, University of Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553838
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2012
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
- ClinicalTrials.gov ID
- NCT01553838
- Acronym / sponsor ID
- 002
- Conditions
- Prostate Cancer
- Keywords
- prostate biopsy, MRI guided biopsy, TRUS guided biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Mar 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 purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequentially MRI guided and TRUS guided biopsy | Experimental | Device: MRI guided prostate biopsy and TRUS guided biopsyTargeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PSA > 4.0 ng/ml
- written informed consent
- age >18
Key exclusion criteria (3 listed)
- patients with prostate cancer
- patients with prior prostate biopsy
- patients with contraindications against MRI or 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 |
|---|---|---|
| MRI guided prostate biopsy and TRUS guided biopsyMRI guided prostate biopsy | Device | Sequentially MRI guided and TRUS guided biopsy |
Primary outcome
Prostate cancer detection rate
Time frame: 3 years
1 secondary outcome
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Time frame: 3 years
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 19 Aug 2014.
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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 of Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided prostate biopsy and TRUS guided biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site 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 3 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: finished, as of the sponsor's last update on 19 Aug 2014. 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 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?
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?
Prostate cancer detection rate (time frame: 3 years). 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 19 Aug 2014.