Prostatic Neoplasm of Uncertain BehaviorBiopsy29NCT06579911
Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer
A study testing High-frequency micro-ultrasound target biopsy and conventional Multiparametric MRT target biopsy in people with Prostatic Neoplasm of Uncertain Behavior, run by Salzburger Landeskliniken at 1 site in Austria.
Trial summary
Study Goal: The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasm of Uncertain Behavior
- What is being tested?
- High-frequency micro-ultrasound target biopsy and conventional Multiparametric MRT target biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2023to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (>= PI-RADS III)
Who cannot join
- Patients with histopathologic proven prostate cancer
- PSA > 20 ng/ml
- Finding in digital rectal examination >= cT2c
- Untreated bacterial infection of the prostate
- Untreated coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, State of Salzburg, 5020
Lukas Lusuardi, Univ.Prof.Dr., 0043 57255 27402, l.lusuardi@salk.at
About this study
Official title: Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does it Increase the Detection Rate of Clinically Significant Prostate Cancer? A Prospective, Interventional, Single Centre, Randomized Controlled Trial
Study Goal: The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer.
Main Questions the Study Aims to Answer:
Read more
- Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method?
- Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects?
Participation in the Study:
Participants in this study will undergo the following procedures:
- A high-frequency micro-ultrasound examination of the prostate.
- A multiparametric MRI-targeted biopsy of the prostate.
- A systematic biopsy of the prostate.
Comparison Group: Researchers will compare the new combination method with the current standard method to see if the new approach is more effective.
Participants will:
- Undergo several exams and biopsies depending on the results of previous tests.
- Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health.
- Record their experiences and any symptoms in a diary.
Read the detailed description
The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).
The fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).
- Conditions
- Prostatic Neoplasm of Uncertain Behavior
- Being tested
- High-frequency micro-ultrasound target biopsy, conventional Multiparametric MRT target biopsy
- Keywords
- Prostate cancer, prostate biopsy, high frequency ultrasound, fusion biopsy, multiparametric mri of prostate, pirads, primus
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency micro-ultrasound target biopsyDevice
- High-frequency micro-ultrasound (transrectal ultrasound, 29 Hz, ExactVu) of the prostate. If suspicious lesions (PRIMUS >= 3) other than those already detected in multiparametric MRI are found, target biopsy will be performed. Maximum of four cores per lesion.
- Multiparametric MRI target biopsy (PI-RADS >= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion.
- Systematic biopsy (twelve cores) of the prostate
conventional Multiparametric MRT target biopsyDevice
- Multiparametric MRT target biopsy (PI-RADS >= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion.
- Systematic biopsy (twelve cores) of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Group U | Experimental | Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection Receives: Device: High-frequency micro-ultrasound target biopsy |
| Group S | Active comparator | Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection Receives: Device: conventional Multiparametric MRT target biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".
Measured: 2 Weeks
Secondary outcomes (1)
Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy
This measure evaluates whether participants have clinically insignificant prostate cancer (Gleason Score Sum = ISUP 1) based on biopsy results, also recorded as "yes" or "no".
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 posted30 Aug 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostatic Neoplasm of Uncertain BehaviorStudies 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
- Participants are randomly divided into two groups. One group (the experimental group) receives the combination of high-frequency micro-ultrasound, multiparametric MRI-targeted biopsy, and systematic biopsy. The other group (the control group) receives the current standard care, which includes only multiparametric MRI-targeted biopsy and systematic biopsy. This setup allows direct comparison of the detection rates of clinically significant prostate cancer between the new combination of interventions and the standard approach.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Pallauf, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579911
- Sponsor's protocol ID
- Biopsy29
- Acronym
- Biopsy29
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers. The data collected from participants will remain confidential and will be used exclusively for the analysis and reporting within the confines of this study. This approach ensures the privacy and security of participant information.
Publications
Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E, Malvezzi M. European cancer mortality predictions for the year 2020 with a focus on prostate cancer. Ann Oncol. 2020 May;31(5):650-658. doi: 10.1016/j.annonc.2020.02.009. Epub 2020 Apr 19.
PubMed 32321669Kim JK, Jang YJ, Cho G. Multidisciplinary functional MR imaging for prostate cancer. Korean J Radiol. 2009 Nov-Dec;10(6):535-51. doi: 10.3348/kjr.2009.10.6.535.
PubMed 19885309Kasivisvanathan V, Stabile A, Neves JB, Giganti F, Valerio M, Shanmugabavan Y, Clement KD, Sarkar D, Philippou Y, Thurtle D, Deeks J, Emberton M, Takwoingi Y, Moore CM. Magnetic Resonance Imaging-targeted Biopsy Versus Systematic Biopsy in the Detection of Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2019 Sep;76(3):284-303. doi: 10.1016/j.eururo.2019.04.043. Epub 2019 May 24.
PubMed 31130434Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
PubMed 30470502Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12.
PubMed 26791931Rodriguez Socarras ME, Gomez Rivas J, Cuadros Rivera V, Reinoso Elbers J, Llanes Gonzalez L, Michel Mercado I, Fernandez Del Alamo J, Juarez Del Dago P, Sancha FG. Prostate Mapping for Cancer Diagnosis: The Madrid Protocol. Transperineal Prostate Biopsies Using Multiparametric Magnetic Resonance Imaging Fusion and Micro-Ultrasound Guided Biopsies. J Urol. 2020 Oct;204(4):726-733. doi: 10.1097/JU.0000000000001083. Epub 2020 Apr 21.
PubMed 32314932Abouassaly R, Klein EA, El-Shefai A, Stephenson A. Impact of using 29 MHz high-resolution micro-ultrasound in real-time targeting of transrectal prostate biopsies: initial experience. World J Urol. 2020 May;38(5):1201-1206. doi: 10.1007/s00345-019-02863-y. Epub 2019 Jul 15.
PubMed 31309290Laurence Klotz CM. Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Eur Urol Focus. 2020 Mar 15;6(2):419-423. doi: 10.1016/j.euf.2019.11.006. Epub 2019 Nov 24.
PubMed 31771935Cornud F, Lefevre A, Flam T, Dumonceau O, Galiano M, Soyer P, Camparo P, Barral M. MRI-directed high-frequency (29MhZ) TRUS-guided biopsies: initial results of a single-center study. Eur Radiol. 2020 Sep;30(9):4838-4846. doi: 10.1007/s00330-020-06882-x. Epub 2020 Apr 29.
PubMed 32350662Wiemer L, Hollenbach M, Heckmann R, Kittner B, Plage H, Reimann M, Asbach P, Friedersdorff F, Schlomm T, Hofbauer S, Cash H. Evolution of Targeted Prostate Biopsy by Adding Micro-Ultrasound to the Magnetic Resonance Imaging Pathway. Eur Urol Focus. 2021 Nov;7(6):1292-1299. doi: 10.1016/j.euf.2020.06.022. Epub 2020 Jul 9.
PubMed 32654967
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does it Increase the Detection Rate of Clinically Significant Prostate Cancer? A Prospective, Interventional, Single Centre, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06579911
- Acronym / sponsor ID
- Biopsy29 / Biopsy29
- Conditions
- Prostatic Neoplasm of Uncertain Behavior
- Keywords
- Prostate cancer, prostate biopsy, high frequency ultrasound, fusion biopsy, multiparametric mri of prostate, pirads, primus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Aug 2024 (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.
Study Goal: The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer.
Main Questions the Study Aims to Answer:
- Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method?
- Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects?
Participation in the Study:
Participants in this study will undergo the following procedures:
- A high-frequency micro-ultrasound examination of the prostate.
- A multiparametric MRI-targeted biopsy of the prostate.
- A systematic biopsy of the prostate.
Comparison Group: Researchers will compare the new combination method with the current standard method to see if the new approach is more effective.
Participants will:
- Undergo several exams and biopsies depending on the results of previous tests.
- Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health.
- Record their experiences and any symptoms in a diary.
Detailed description
The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).
The fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly divided into two groups. One group (the experimental group) receives the combination of high-frequency micro-ultrasound, multiparametric MRI-targeted biopsy, and systematic biopsy. The other group (the control group) receives the current standard care, which includes only multiparametric MRI-targeted biopsy and systematic biopsy. This setup allows direct comparison of the detection rates of clinically significant prostate cancer between the new combination of interventions and the standard approach.
| Arm | Type | Receives |
|---|---|---|
| Group U | Experimental | Device: High-frequency micro-ultrasound target biopsyUse of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection |
| Group S | Active comparator | Device: conventional Multiparametric MRT target biopsyUse of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (>= PI-RADS III)
Key exclusion criteria (5 listed)
- Patients with histopathologic proven prostate cancer
- PSA > 20 ng/ml
- Finding in digital rectal examination >= cT2c
- Untreated bacterial infection of the prostate
- Untreated coagulopathy
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 |
|---|---|---|
| High-frequency micro-ultrasound target biopsy1. High-frequency micro-ultrasound (transrectal ultrasound, 29 Hz, ExactVu) of the prostate. If suspicious lesions (PRIMUS >= 3) other than those already detected in multiparametric MRI are found, target biopsy will be performed. Maximum of four cores per lesion. 2. Multiparametric MRI target biopsy (PI-RADS >= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion. 3. Systematic biopsy (twelve cores) of the prostate | Device | Group U |
| conventional Multiparametric MRT target biopsy1. Multiparametric MRT target biopsy (PI-RADS >= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion. 2. Systematic biopsy (twelve cores) of the prostate | Device | Group S |
Primary outcome
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
Time frame: 2 Weeks
This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".
1 secondary outcome
Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy
Time frame: 2 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 32321669Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E, Malvezzi M. European cancer mortality predictions for the year 2020 with a focus on prostate cancer. Ann Oncol. 2020 May;31(5):650-658. doi: 10.1016/j.annonc.2020.02.009. Epub 2020 Apr 19.
- Background: PubMed 19885309Kim JK, Jang YJ, Cho G. Multidisciplinary functional MR imaging for prostate cancer. Korean J Radiol. 2009 Nov-Dec;10(6):535-51. doi: 10.3348/kjr.2009.10.6.535.
- Background: PubMed 31130434Kasivisvanathan V, Stabile A, Neves JB, Giganti F, Valerio M, Shanmugabavan Y, Clement KD, Sarkar D, Philippou Y, Thurtle D, Deeks J, Emberton M, Takwoingi Y, Moore CM. Magnetic Resonance Imaging-targeted Biopsy Versus Systematic Biopsy in the Detection of Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2019 Sep;76(3):284-303. doi: 10.1016/j.eururo.2019.04.043. Epub 2019 May 24.
- Background: PubMed 30470502Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
- Background: PubMed 26791931Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12.
- Background: PubMed 32314932Rodriguez Socarras ME, Gomez Rivas J, Cuadros Rivera V, Reinoso Elbers J, Llanes Gonzalez L, Michel Mercado I, Fernandez Del Alamo J, Juarez Del Dago P, Sancha FG. Prostate Mapping for Cancer Diagnosis: The Madrid Protocol. Transperineal Prostate Biopsies Using Multiparametric Magnetic Resonance Imaging Fusion and Micro-Ultrasound Guided Biopsies. J Urol. 2020 Oct;204(4):726-733. doi: 10.1097/JU.0000000000001083. Epub 2020 Apr 21.
- Background: PubMed 31309290Abouassaly R, Klein EA, El-Shefai A, Stephenson A. Impact of using 29 MHz high-resolution micro-ultrasound in real-time targeting of transrectal prostate biopsies: initial experience. World J Urol. 2020 May;38(5):1201-1206. doi: 10.1007/s00345-019-02863-y. Epub 2019 Jul 15.
- Background: PubMed 31771935Laurence Klotz CM. Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Eur Urol Focus. 2020 Mar 15;6(2):419-423. doi: 10.1016/j.euf.2019.11.006. Epub 2019 Nov 24.
- Background: PubMed 32350662Cornud F, Lefevre A, Flam T, Dumonceau O, Galiano M, Soyer P, Camparo P, Barral M. MRI-directed high-frequency (29MhZ) TRUS-guided biopsies: initial results of a single-center study. Eur Radiol. 2020 Sep;30(9):4838-4846. doi: 10.1007/s00330-020-06882-x. Epub 2020 Apr 29.
- Background: PubMed 32654967Wiemer L, Hollenbach M, Heckmann R, Kittner B, Plage H, Reimann M, Asbach P, Friedersdorff F, Schlomm T, Hofbauer S, Cash H. Evolution of Targeted Prostate Biopsy by Adding Micro-Ultrasound to the Magnetic Resonance Imaging Pathway. Eur Urol Focus. 2021 Nov;7(6):1292-1299. doi: 10.1016/j.euf.2020.06.022. Epub 2020 Jul 9.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared with other researchers. The data collected from participants will remain confidential and will be used exclusively for the analysis and reporting within the confines of this study. This approach ensures the privacy and security of participant information.
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.
Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency micro-ultrasound target biopsy and conventional Multiparametric MRT target biopsy in people with Prostatic Neoplasm of Uncertain Behavior, run by Salzburger Landeskliniken at 1 site in Austria.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Jun 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy (time frame: 2 Weeks). 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 NCT06579911, which also lists 10 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 9 Jun 2026.