Prostate CancerNCT04832997
Micro-ultrasound for Prostate Cancer Diagnosis
A study testing Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx) in people with Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a single-center, paired-cohort, prospective study. Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits. The results of the diagnostic procedures will determine how many and which type prostate biopsies patients will undergo. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2020to 16 Jul 2025
- 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
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Who cannot join
- Prior treatment for prostate cancer
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
- Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
- Unfit to undergo any procedures listed in protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-ultrasound or MRI-targeted Biopsy for Prostate Cancer Diagnosis
This is a single-center, paired-cohort, prospective study. Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits. The results of the diagnostic procedures will determine how many and which type prostate biopsies patients will undergo. During the following visit, patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS ≥ 3 and PRI-MUS ≥ 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx (Group 4). Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx (Group 1). Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx (Group 2). Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx (Group 3).
Our hypothesis is that the sensitivity for csPCa (defined as prostate cancer with Gleason score ≥ 3+4) of Micro-US will be superior or at least equal to that of mpMRI. Despite the introduction of the mpMRI and MRI-TBx has improved the diagnostic pathway of PCa, the proportion of men with negative mpMRI with a csPCa is still difficult to delineate due to the high variability of mpMRI negative predictive value (NPV) and specificity. In this context, a specific standardization of the use of Micro-US may play a crucial role to optimize PCa diagnostic pathway. Moreover, a direct comparison between Micro-US and mpMRI might be useful to determinate whether Micro-US could be more accurate than mpMRI for PCa diagnosis. Furthermore, in patients with suspicion of PCa the combined use between mpMRI and Micro-US might increase the detection of csPCa and reduce the number of unnecessary biopsies, improving mpMRI limitations in NPV and specificity. Demonstrating that Micro-US provides a similar sensitivity for csPCa as compared to mpMRI may lead to its definitive inclusion in daily clinical practice, potentially replacing mpMRI, streamlining the current diagnostic pathway of PCa.
- Conditions
- Prostate Cancer
- Being tested
- Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)Diagnostic test
Patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS >= 3 and PRI-MUS >= 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx. Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx. Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx. Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx.
| Study group | Role | What they receive |
|---|---|---|
| mpMRI plus Micro-US | Experimental | Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits (randomized sequence). The results of the diagnostic procedures will determine how many and which type of prostate biopsies patients will undergo. Receives: Diagnostic Test: Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI
To compare the sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI
Measured: through study completation, an average time of 2 years
Secondary outcomes (4)
Proportion of clinically significant prostate cancer detected with the inclusion of Micro-US within the diagnostic pathway of prostate cancer
To report the diagnostic benefit related with the use of Micro-US in the prostate cancer diagnostic pathway
Measured: through study completation, an average time of 2 years
Proportion of men with clinically insignificant prostate cancer detected by MRI-TBx vs. Micro-US-TBx
Measured: through study completation, an average time of 2 years
Proportion of men with at least one lesion detected by mpMRI vs. Micro-US
Measured: through study completation, an average time of 2 years
Proportion of men with clinically significant prostate cancer detected by Micro-US-TBx missed by MRI-TBx and vice-versa
Measured: through study completation, an average time of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start14 Sep 2020
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Why it stopped: The study faced structural and methodological obstacles, with limited enrollment, technical issues, low adherence, and loss of scientific relevance.
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 IRCCS San RaffaeleThe 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
- Model description
- Every patient will receive the same diagnostic test (MRI and Micro-US) in a randomized sequence
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Alberto Briganti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832997
- Sponsor's protocol ID
- US-MIRROR
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-ultrasound or MRI-targeted Biopsy for Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT04832997
- Acronym / sponsor ID
- US-MIRROR
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study faced structural and methodological obstacles, with limited enrollment, technical issues, low adherence, and loss of scientific relevance.
- Enrolment
- 96 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 6 Apr 2021 (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.
This is a single-center, paired-cohort, prospective study. Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits. The results of the diagnostic procedures will determine how many and which type prostate biopsies patients will undergo. During the following visit, patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS ≥ 3 and PRI-MUS ≥ 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx (Group 4). Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx (Group 1). Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx (Group 2). Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx (Group 3).
Our hypothesis is that the sensitivity for csPCa (defined as prostate cancer with Gleason score ≥ 3+4) of Micro-US will be superior or at least equal to that of mpMRI. Despite the introduction of the mpMRI and MRI-TBx has improved the diagnostic pathway of PCa, the proportion of men with negative mpMRI with a csPCa is still difficult to delineate due to the high variability of mpMRI negative predictive value (NPV) and specificity. In this context, a specific standardization of the use of Micro-US may play a crucial role to optimize PCa diagnostic pathway. Moreover, a direct comparison between Micro-US and mpMRI might be useful to determinate whether Micro-US could be more accurate than mpMRI for PCa diagnosis. Furthermore, in patients with suspicion of PCa the combined use between mpMRI and Micro-US might increase the detection of csPCa and reduce the number of unnecessary biopsies, improving mpMRI limitations in NPV and specificity. Demonstrating that Micro-US provides a similar sensitivity for csPCa as compared to mpMRI may lead to its definitive inclusion in daily clinical practice, potentially replacing mpMRI, streamlining the current diagnostic pathway of PCa.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every patient will receive the same diagnostic test (MRI and Micro-US) in a randomized sequence
| Arm | Type | Receives |
|---|---|---|
| mpMRI plus Micro-US | Experimental | Diagnostic Test: Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits (randomized sequence). The results of the diagnostic procedures will determine how many and which type of prostate biopsies patients will undergo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
- Serum PSA ≤ 20ng/ml
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Prior treatment for prostate cancer
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
- Contraindication to prostate biopsy
- Men in whom artifact would reduce the quality of the MRI
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 |
|---|---|---|
| Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)Patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS >= 3 and PRI-MUS >= 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx. Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx. Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx. Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx. | Diagnostic test | mpMRI plus Micro-US |
Primary outcome
Sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI
Time frame: through study completation, an average time of 2 years
To compare the sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI
4 secondary outcomes
Proportion of clinically significant prostate cancer detected with the inclusion of Micro-US within the diagnostic pathway of prostate cancer
Time frame: through study completation, an average time of 2 years
Proportion of men with clinically insignificant prostate cancer detected by MRI-TBx vs. Micro-US-TBx
Time frame: through study completation, an average time of 2 years
Proportion of men with at least one lesion detected by mpMRI vs. Micro-US
Time frame: through study completation, an average time of 2 years
Proportion of men with clinically significant prostate cancer detected by Micro-US-TBx missed by MRI-TBx and vice-versa
Time frame: through study completation, an average time of 2 years
Results and safety
The study was stopped early (reason given: The study faced structural and methodological obstacles, with limited enrollment, technical issues, low adherence, and loss of scientific relevance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx) in people with Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Jul 2025. 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 Italy. 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 was stopped early (reason given: The study faced structural and methodological obstacles, with limited enrollment, technical issues, low adherence, and loss of scientific relevance.). Results are not available in the source record.
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?
Sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI (time frame: through study completation, an average time of 2 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 20 Jul 2025.