Prostate CancerPhase 2ElaProCNCT02425163
Shear Wave Elastography of Prostate Cancer
A Phase 2 study testing Transrectal shear wave elastography of the prostate and Transrectal random biopsy of the prostate in people with Prostate Cancer, run by University of Magdeburg at 1 site in Germany.
Trial summary
Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transrectal shear wave elastography of the prostate and Transrectal random biopsy of the prostate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Jan 2015
- Phase
- Phase 2
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) >4ng/ml or PSA velocity > 0.75 ng/ml per year or suspicious transrectal digital examination
- Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.
Read the detailed description
This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.
- Conditions
- Prostate Cancer
- Being tested
- Transrectal shear wave elastography of the prostate, Transrectal random biopsy of the prostate
- Keywords
- Prostate Cancer, Shear Wave Elastography, Prostate, 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.
Transrectal shear wave elastography of the prostateDevice
Also called SuperSonic Imagine Ultrasound System
Transrectal shear wave elastography of the prostate with SuperSonic Imagine Ultrasound System AIXPLORER and an endocavity sonic head SE12-3 (SuperSonic Imagine, Aix-en-Provence, France)
Transrectal random biopsy of the prostateProcedure or surgery
Also called TRUS-SWE-guided random biopsies of the prostata
TRUS-SWE-guided random biopsies of the Prostata with 18G-gun
| Study group | Role | What they receive |
|---|---|---|
| suspicious for Prostate Cancer | Active comparator | PSA >4ng/ml or PSA-Velocity >0.75ng/ml/a or suspicious rectal examination or Status after external beam therapy of the prostate in prostate cancer.
Patients who are able for transrectal ultrasound examination. Transrectal shear wave elastography of the prostate for Transrectal random biopsy of the prostate. Receives: Device: Transrectal shear wave elastography of the prostate; Procedure: Transrectal random biopsy of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave elastography
transrectal shear wave elastography with detection of prostate tissue pressure [kilo-Pascal] in correspondence to biopsy areas
Measured: 12 Months
Secondary outcomes (4)
Differentiation of Entity by Elastography
Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)
Measured: 12 Months
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Measured: 12 Months
Differentiation of Prostate cancer malignity by Elastography
Differentiation of low-risk versus intermediate and high-risk Prostate cancer malignity (Gleason score 6 vs. 7-10) by Elastography
Measured: 12 Months
Histopathological Analysis
Histopathological Analysis of biopsy specimen: benign prostate hyperplasia
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Martin Schostak, Prof. Dr., Principal investigator, Urologische Klinik, Otto-von-Guericke University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425163
- Sponsor's protocol ID
- MD-URO-0047
- Acronym
- ElaProC
- Status last verified
- Apr 2015
- First submitted
- 10 Feb 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Correas JM, Tissier AM, Khairoune A, Vassiliu V, Mejean A, Helenon O, Memo R, Barr RG. Prostate cancer: diagnostic performance of real-time shear-wave elastography. Radiology. 2015 Apr;275(1):280-9. doi: 10.1148/radiol.14140567. Epub 2014 Nov 19.
PubMed 25599156
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02425163
- Acronym / sponsor ID
- ElaProC / MD-URO-0047
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Shear Wave Elastography, Prostate, Prostate Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Apr 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.
Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.
Detailed description
This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspicious for Prostate Cancer | Active comparator | Device: Transrectal shear wave elastography of the prostate, Procedure: Transrectal random biopsy of the prostatePSA >4ng/ml or PSA-Velocity >0.75ng/ml/a or suspicious rectal examination or Status after external beam therapy of the prostate in prostate cancer. Patients who are able for transrectal ultrasound examination. Transrectal shear wave elastography of the prostate for Transrectal random biopsy of the prostate. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) >4ng/ml or PSA velocity > 0.75 ng/ml per year or suspicious transrectal digital examination
- Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Transrectal shear wave elastography of the prostateAlso: SuperSonic Imagine Ultrasound SystemTransrectal shear wave elastography of the prostate with SuperSonic Imagine Ultrasound System AIXPLORER and an endocavity sonic head SE12-3 (SuperSonic Imagine, Aix-en-Provence, France) | Device | suspicious for Prostate Cancer |
| Transrectal random biopsy of the prostateAlso: TRUS-SWE-guided random biopsies of the prostataTRUS-SWE-guided random biopsies of the Prostata with 18G-gun | Procedure or surgery | suspicious for Prostate Cancer |
Primary outcome
Shear wave elastography
Time frame: 12 Months
transrectal shear wave elastography with detection of prostate tissue pressure [kilo-Pascal] in correspondence to biopsy areas
4 secondary outcomes
Differentiation of Entity by Elastography
Time frame: 12 Months
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Time frame: 12 Months
Differentiation of Prostate cancer malignity by Elastography
Time frame: 12 Months
Histopathological Analysis
Time frame: 12 Months
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 23 Apr 2015.
- Results publication: PubMed 25599156Correas JM, Tissier AM, Khairoune A, Vassiliu V, Mejean A, Helenon O, Memo R, Barr RG. Prostate cancer: diagnostic performance of real-time shear-wave elastography. Radiology. 2015 Apr;275(1):280-9. doi: 10.1148/radiol.14140567. Epub 2014 Nov 19.
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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.
Martin Schostak, Prof. Dr. principal investigator
Urologische Klinik, Otto-von-Guericke University Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transrectal shear wave elastography of the prostate and Transrectal random biopsy of the prostate in people with Prostate Cancer, run by University of Magdeburg 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 2 inclusion and 1 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 23 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Shear wave elastography (time frame: 12 Months). 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 NCT02425163, which also lists 1 linked publication.
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 23 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.