Prostate CancerMUS-ASNCT07386171
Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance
A study testing Micro-Ultrasound (mUS) in people with Prostate Cancer and Active Surveillance for Prostate Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Active surveillance is a common approach for men with low-risk or favorable intermediate-risk prostate cancer, aimed at avoiding or delaying treatment while closely monitoring the disease. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Active Surveillance for Prostate Cancer, Imaging Techniques
- What is being tested?
- Micro-Ultrasound (mUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2026to 1 Jun 2027
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 45 to 75 years
- Localized prostate cancer on active surveillance or newly diagnosed and eligible for active surveillance
- Negative multiparametric MRI (PI-RADS ≤2) or stable mpMRI findings on surveillance
- Prior prostate biopsy showing Grade Group 1, or Grade Group 2 (Gleason 3+4) with ≤10% pattern 4
- PSA ≤15 ng/mL
- PSA density <0.15 ng/mL/cc
Show all 9Show fewer
- Clinical stage ≤T2a
- Life expectancy >10 years
- Ability to provide written informed consent and comply with study procedures
Who cannot join
- Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy)
- Prior prostate surgery that may affect biopsy or imaging interpretation
- Contraindication to prostate biopsy
- Active urinary tract infection or prostatitis
- Inability to tolerate the biopsy procedure or follow study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Rocio Roldan-Testillano, MD, 4388285227, rocio.roldan@mcgill.ca
Claudia Covarrubias, MD, (514) 704-9160, claudia.covarrubias@mail.mcgill.ca
About this study
Official title: Evaluating Micro-Ultrasound as a Supplemental Imaging Modality for Clinically Significant Prostate Cancer Detection in Men With Negative or Stable Multiparametric MRI on Active Surveillance or at Diagnosis
Active surveillance is a common approach for men with low-risk or favorable intermediate-risk prostate cancer, aimed at avoiding or delaying treatment while closely monitoring the disease. Multiparametric MRI (mpMRI) is widely used to guide diagnosis and follow-up, but it can miss clinically significant prostate cancer and may be limited by access, cost, and variability in interpretation.
Micro-ultrasound is a high-resolution ultrasound technique that may improve real-time detection of suspicious prostate lesions using a standardized scoring system (PRI-MUS). The purpose of this study is to evaluate the diagnostic performance of micro-ultrasound for detecting clinically significant prostate cancer in men with negative or stable mpMRI findings, either at initial diagnosis or during active surveillance follow-up.
Read more
Participants will undergo micro-ultrasound assessment of the prostate. Areas considered suspicious on micro-ultrasound may be targeted for biopsy, followed by systematic prostate sampling. Biopsy results will be used as the reference standard to determine whether clinically significant prostate cancer is present.
The study will assess measures such as sensitivity, specificity, and predictive values of micro-ultrasound, as well as procedure-related complications.
Read the detailed description
Study Rationale This is a prospective, single-arm, two-stage phase II diagnostic study designed to evaluate micro-ultrasound (mUS) as a supplemental imaging modality for the detection of clinically significant prostate cancer (csPCa) in men undergoing active surveillance (AS), or newly diagnosed men eligible for AS, with negative (PI-RADS ≤2) or stable multiparametric MRI (mpMRI) findings.
Active surveillance is widely adopted for men with low-risk and selected favorable intermediate-risk prostate cancer (PCa), aiming to defer or avoid definitive treatment while maintaining oncologic safety through structured monitoring.
mpMRI has become central to risk stratification, patient selection, and follow-up. However, clinically significant disease can be missed despite negative or stable mpMRI findings due to false-negative scans, inter-reader variability, limited access, and cost constraints. These limitations may lead to underdetection of csPCa and potential delays in appropriate treatment. In contrast to mpMRI, mUS can be performed at the point of care during the urology visit, enabling real-time lesion assessment and immediate targeted biopsy without the need to wait for radiology reporting, which may help mitigate MRI-related access delays and workflow bottlenecks.
mUS is a high-frequency ultrasound technology (29 MHz) providing real-time, high-resolution imaging of the prostate, enabling lesion characterization using the Prostate Risk Identification using Micro-Ultrasound (PRI-MUS) scoring system. mUS may detect suspicious features not identified on mpMRI and may therefore improve detection of csPCa, particularly in men with negative or stable mpMRI who are still undergoing biopsy due to clinical triggers or surveillance protocols.
Study Objectives The primary objective of this study is to determine the diagnostic performance of mUS for detecting csPCa in this population, using histopathology as the reference standard.
Secondary objectives include:
- Evaluating positive and negative predictive values of mUS.
- Estimating the incremental detection of csPCa provided by mUS compared with mpMRI alone.
- Evaluating concordance between mpMRI and mUS lesion identification and risk classification.
- Describing biopsy-related adverse events and complications using standardized reporting and grading.
Study Design This is a prospective, single-arm, diagnostic accuracy study incorporating a two-stage phase II design (Simon two-stage design). The study will evaluate whether the detection rate and sensitivity of mUS for csPCa meets a pre-specified threshold that would justify broader implementation or future comparative studies.
The two-stage design allows for early termination for futility if interim results indicate that the diagnostic performance of mUS is insufficient. If the performance targets are met in Stage 1, the study proceeds to Stage 2 to complete the planned sample size and provide more precise estimates of diagnostic accuracy.
Study Population Participants are men aged 45 to 75 years with localized PCa enrolled in AS or newly diagnosed and eligible for AS, who have either negative mpMRI (PI-RADS ≤2) or stable mpMRI findings over time.
Eligibility criteria include features consistent with low-risk or favorable intermediate-risk disease, as determined by prior biopsy results, PSA values, and clinical staging.
Study Procedures All participants will undergo mUS assessment of the prostate according to a standardized imaging protocol. The prostate will be systematically examined, and lesions will be scored using the PRI-MUS risk stratification system. Lesions scored PRI-MUS ≥3 will be considered suspicious and will be targeted for biopsy under micro-ultrasound guidance. Following targeted sampling (when applicable), all participants will undergo systematic prostate biopsy (12-core sampling) during the same procedure session. Targeted and systematic biopsy cores will be analyzed by experienced genitourinary pathologists using standardized reporting. Histopathology will serve as the reference standard for determining the presence or absence of csPCa.
Definition of (csPCa) Clinically significant PCa is defined as Grade Group ≥2 (Gleason score ≥3+4) detected in any biopsy core (targeted or systematic). This definition is aligned with contemporary AS risk thresholds and is intended to capture disease that may warrant treatment escalation or intensified monitoring.
Outcomes
- Primary outcome measures include sensitivity and specificity of mUS for detecting csPCa (Grade Group ≥2). mUS "test positivity" will be defined based on PRI-MUS score thresholds (PRI-MUS ≥3) and/or the presence of a targetable lesion on mUS.
- Secondary outcome measures include positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy. Incremental csPCa detection attributable to mUS will be assessed by describing csPCa detected in mUS-targeted cores and comparing detection patterns relative to mpMRI findings (negative vs stable findings) and other clinical parameters.
Agreement between mpMRI and mUS lesion identification will be assessed using appropriate concordance metrics (e.g., Cohen's kappa) when applicable.
-Safety outcomes will include biopsy-related adverse events, including infectious complications, urinary retention, bleeding events, pain, and other procedure-related outcomes. Adverse events will be collected prospectively and categorized according to standardized definitions, and clinically relevant complications will be graded using established severity classifications (e.g., Clavien-Dindo).
Statistical Considerations Diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV) will be reported with confidence intervals. The study's two-stage phase II design provides an efficient approach to determining whether mUS demonstrates adequate diagnostic performance for csPCa detection in this clinically important subgroup of men with negative or stable mpMRI findings. Interim analysis will be performed after completion of Stage 1 enrollment and histopathology outcomes, with progression to Stage 2 contingent on meeting the predefined performance threshold.
Clinical Significance This study addresses an unmet need within the AS pathway: improving detection of csPCa in men with negative or stable mpMRI who remain at risk of harboring higher-grade disease. If mUS demonstrates high sensitivity and useful NPV, it may support improved risk stratification, reduce missed csPCa, and optimize biopsy decision-making. The findings may inform future diagnostic strategies and pathway refinement, including how mUS can be integrated with mpMRI in AS and early detection settings.
- Being tested
- Micro-Ultrasound (mUS)
- Keywords
- Active Surveillance Prostate Cancer, Prostate Cancer Imaging, Micro-ultrasound, Multiparametric MRI, Clinically significant prostate cancer, Targeted-Systematic 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.
Micro-Ultrasound (mUS)Diagnostic test
High-frequency micro-ultrasound prostate imaging with real-time lesion assessment. Targeted biopsy of suspicious lesions will be performed when present, along with concurrent systematic 12-core biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Micro-Ultrasound Imaging and Biopsy | Experimental | All participants will undergo micro-ultrasound prostate assessment. If a suspicious lesion is identified, targeted biopsy will be performed. All participants will also undergo a 12-core systematic biopsy during the same session. Receives: Diagnostic Test: Micro-Ultrasound (mUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Sensitivity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
Measured: At the time of the study biopsy procedure (baseline)
Specificity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Specificity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
Measured: At the time of the study biopsy procedure (baseline)
Secondary outcomes (5)
Positive Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Positive predictive value of micro-ultrasound for detecting clinically significant prostate cancer, defined as Grade Group ≥2, using histopathology as the reference standard.
Measured: At the time of the study biopsy procedure (baseline)
Negative Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Negative predictive value of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology as the reference standard.
Measured: At the time of the study biopsy procedure (baseline)
Overall Diagnostic Accuracy of Micro-Ultrasound for csPCa (Grade Group ≥2)
Overall diagnostic accuracy of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology as the reference standard.
Measured: At the time of the study biopsy procedure (baseline)
Incremental Detection of csPCa Using Micro-Ultrasound Targeted Biopsy
Number and proportion of clinically significant prostate cancers (Grade Group ≥2) detected on micro-ultrasound targeted biopsy cores, including csPCa cases that would not have been detected by systematic biopsy alone.
Measured: At the time of the study biopsy procedure (baseline)
Concordance Between Micro-Ultrasound Findings and mpMRI Findings
Agreement between micro-ultrasound and multiparametric MRI findings for lesion identification and risk categorization.
Measured: At the time of the study biopsy procedure (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Single-arm diagnostic study in which all participants undergo micro-ultrasound assessment. Participants with PRI-MUS ≥3 lesions receive targeted biopsy, and all participants undergo systematic 12-core biopsy during the same session.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Sanchez-Salas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Maurice Anidjar, MD, PhD, Study chair, Jewish General HospitalRafael Sanchez-Salas, MD, Principal investigator, McGill Universiy Health Center // Jewish General HospitalRocio Roldan-Testillano, MD, Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386171
- Sponsor's protocol ID
- MUHC-MICROUS-AS-2026-01
- Acronym
- MUS-AS
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participant privacy and confidentiality. De-identified data may be made available upon reasonable request and subject to institutional approvals and applicable ethics requirements.
Publications
Wang L, Lu B, He M, Wang Y, Wang Z, Du L. Prostate Cancer Incidence and Mortality: Global Status and Temporal Trends in 89 Countries From 2000 to 2019. Front Public Health. 2022 Feb 16;10:811044. doi: 10.3389/fpubh.2022.811044. eCollection 2022.
PubMed 35252092Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PubMed 28110982Albers P, Wang B, Broomfield S, Medina Martin A, Fung C, Kinnaird A. Micro-ultrasound Versus Magnetic Resonance Imaging in Prostate Cancer Active Surveillance. Eur Urol Open Sci. 2022 Oct 25;46:33-35. doi: 10.1016/j.euros.2022.09.019. eCollection 2022 Dec.
PubMed 36325366Albers P, Bennett J, Evans M, St Martin E, Wang B, Broomfield S, Martin AM, Tu W, Fung C, Kinnaird A. Micro-ultrasound for the detection of clinically significant prostate cancer in biopsy-naive men with negative MRI. Can Urol Assoc J. 2024 Jun;18(6):208-211. doi: 10.5489/cuaj.8626.
PubMed 38587980Kinnaird A, Luger F, Cash H, Ghai S, Urdaneta-Salegui LF, Pavlovich CP, Brito J, Shore ND, Struck JP, Schostak M, Harland N, Rodriguez-Socarras M, Brisbane WG, Lughezzani G, Toledano H, Ouertani MS, Macek P, Fung C, Tu W, Gusenleitner A, Gunzel K, Incze PF, George AK, Pereira JG, Jansen R, Renzulli J 2nd, Klotz L; OPTIMUM Investigators. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. 2025 May 20;333(19):1679-1687. doi: 10.1001/jama.2025.3579.
PubMed 40121537Basso Dias A, Ghai S. Micro-Ultrasound: Current Role in Prostate Cancer Diagnosis and Future Possibilities. Cancers (Basel). 2023 Feb 17;15(4):1280. doi: 10.3390/cancers15041280.
PubMed 36831622Scott R, Misser SK, Cioni D, Neri E. PI-RADS v2.1: What has changed and how to report. SA J Radiol. 2021 Jun 1;25(1):2062. doi: 10.4102/sajr.v25i1.2062. eCollection 2021.
PubMed 34230862Drost FH, Osses D, Nieboer D, Bangma CH, Steyerberg EW, Roobol MJ, Schoots IG. Prostate Magnetic Resonance Imaging, with or Without Magnetic Resonance Imaging-targeted Biopsy, and Systematic Biopsy for Detecting Prostate Cancer: A Cochrane Systematic Review and Meta-analysis. Eur Urol. 2020 Jan;77(1):78-94. doi: 10.1016/j.eururo.2019.06.023. Epub 2019 Jul 18.
PubMed 31326219Klotz L. Active surveillance in intermediate-risk prostate cancer. BJU Int. 2020 Mar;125(3):346-354. doi: 10.1111/bju.14935. Epub 2020 Jan 16.
PubMed 31647166Tosoian JJ, Mamawala M, Epstein JI, Landis P, Macura KJ, Simopoulos DN, Carter HB, Gorin MA. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Eur Urol. 2020 Jun;77(6):675-682. doi: 10.1016/j.eururo.2019.12.017. Epub 2020 Jan 7.
PubMed 31918957Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Brunckhorst O, Darraugh J, Eberli D, De Meerleer G, De Santis M, Farolfi A, Gandaglia G, Gillessen S, Grivas N, Henry AM, Lardas M, van Leenders GJLH, Liew M, Linares Espinos E, Oldenburg J, van Oort IM, Oprea-Lager DE, Ploussard G, Roberts MJ, Rouviere O, Schoots IG, Schouten N, Smith EJ, Stranne J, Wiegel T, Willemse PM, Tilki D. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024 Aug;86(2):148-163. doi: 10.1016/j.eururo.2024.03.027. Epub 2024 Apr 13.
PubMed 38614820Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, Eggener S, Horwitz EM, Kane CJ, Kirkby E, Lin DW, McBride SM, Morgans AK, Pierorazio PM, Rodrigues G, Wong WW, Boorjian SA. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, Part I: Introduction, Risk Assessment, Staging, and Risk-Based Management. J Urol. 2022 Jul;208(1):10-18. doi: 10.1097/JU.0000000000002757. Epub 2022 May 10.
PubMed 35536144
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Micro-Ultrasound as a Supplemental Imaging Modality for Clinically Significant Prostate Cancer Detection in Men With Negative or Stable Multiparametric MRI on Active Surveillance or at Diagnosis
- ClinicalTrials.gov ID
- NCT07386171
- Acronym / sponsor ID
- MUS-AS / MUHC-MICROUS-AS-2026-01
- Keywords
- Active Surveillance Prostate Cancer, Prostate Cancer Imaging, Micro-ultrasound, Multiparametric MRI, Clinically significant prostate cancer, Targeted-Systematic biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Active surveillance is a common approach for men with low-risk or favorable intermediate-risk prostate cancer, aimed at avoiding or delaying treatment while closely monitoring the disease. Multiparametric MRI (mpMRI) is widely used to guide diagnosis and follow-up, but it can miss clinically significant prostate cancer and may be limited by access, cost, and variability in interpretation.
Micro-ultrasound is a high-resolution ultrasound technique that may improve real-time detection of suspicious prostate lesions using a standardized scoring system (PRI-MUS). The purpose of this study is to evaluate the diagnostic performance of micro-ultrasound for detecting clinically significant prostate cancer in men with negative or stable mpMRI findings, either at initial diagnosis or during active surveillance follow-up.
Participants will undergo micro-ultrasound assessment of the prostate. Areas considered suspicious on micro-ultrasound may be targeted for biopsy, followed by systematic prostate sampling. Biopsy results will be used as the reference standard to determine whether clinically significant prostate cancer is present.
The study will assess measures such as sensitivity, specificity, and predictive values of micro-ultrasound, as well as procedure-related complications.
Detailed description
Study Rationale This is a prospective, single-arm, two-stage phase II diagnostic study designed to evaluate micro-ultrasound (mUS) as a supplemental imaging modality for the detection of clinically significant prostate cancer (csPCa) in men undergoing active surveillance (AS), or newly diagnosed men eligible for AS, with negative (PI-RADS ≤2) or stable multiparametric MRI (mpMRI) findings.
Active surveillance is widely adopted for men with low-risk and selected favorable intermediate-risk prostate cancer (PCa), aiming to defer or avoid definitive treatment while maintaining oncologic safety through structured monitoring.
mpMRI has become central to risk stratification, patient selection, and follow-up. However, clinically significant disease can be missed despite negative or stable mpMRI findings due to false-negative scans, inter-reader variability, limited access, and cost constraints. These limitations may lead to underdetection of csPCa and potential delays in appropriate treatment. In contrast to mpMRI, mUS can be performed at the point of care during the urology visit, enabling real-time lesion assessment and immediate targeted biopsy without the need to wait for radiology reporting, which may help mitigate MRI-related access delays and workflow bottlenecks.
mUS is a high-frequency ultrasound technology (29 MHz) providing real-time, high-resolution imaging of the prostate, enabling lesion characterization using the Prostate Risk Identification using Micro-Ultrasound (PRI-MUS) scoring system. mUS may detect suspicious features not identified on mpMRI and may therefore improve detection of csPCa, particularly in men with negative or stable mpMRI who are still undergoing biopsy due to clinical triggers or surveillance protocols.
Study Objectives The primary objective of this study is to determine the diagnostic performance of mUS for detecting csPCa in this population, using histopathology as the reference standard.
Secondary objectives include:
- Evaluating positive and negative predictive values of mUS.
- Estimating the incremental detection of csPCa provided by mUS compared with mpMRI alone.
- Evaluating concordance between mpMRI and mUS lesion identification and risk classification.
- Describing biopsy-related adverse events and complications using standardized reporting and grading.
Study Design This is a prospective, single-arm, diagnostic accuracy study incorporating a two-stage phase II design (Simon two-stage design). The study will evaluate whether the detection rate and sensitivity of mUS for csPCa meets a pre-specified threshold that would justify broader implementation or future comparative studies.
The two-stage design allows for early termination for futility if interim results indicate that the diagnostic performance of mUS is insufficient. If the performance targets are met in Stage 1, the study proceeds to Stage 2 to complete the planned sample size and provide more precise estimates of diagnostic accuracy.
Study Population Participants are men aged 45 to 75 years with localized PCa enrolled in AS or newly diagnosed and eligible for AS, who have either negative mpMRI (PI-RADS ≤2) or stable mpMRI findings over time.
Eligibility criteria include features consistent with low-risk or favorable intermediate-risk disease, as determined by prior biopsy results, PSA values, and clinical staging.
Study Procedures All participants will undergo mUS assessment of the prostate according to a standardized imaging protocol. The prostate will be systematically examined, and lesions will be scored using the PRI-MUS risk stratification system. Lesions scored PRI-MUS ≥3 will be considered suspicious and will be targeted for biopsy under micro-ultrasound guidance. Following targeted sampling (when applicable), all participants will undergo systematic prostate biopsy (12-core sampling) during the same procedure session. Targeted and systematic biopsy cores will be analyzed by experienced genitourinary pathologists using standardized reporting. Histopathology will serve as the reference standard for determining the presence or absence of csPCa.
Definition of (csPCa) Clinically significant PCa is defined as Grade Group ≥2 (Gleason score ≥3+4) detected in any biopsy core (targeted or systematic). This definition is aligned with contemporary AS risk thresholds and is intended to capture disease that may warrant treatment escalation or intensified monitoring.
Outcomes
- Primary outcome measures include sensitivity and specificity of mUS for detecting csPCa (Grade Group ≥2). mUS "test positivity" will be defined based on PRI-MUS score thresholds (PRI-MUS ≥3) and/or the presence of a targetable lesion on mUS.
- Secondary outcome measures include positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy. Incremental csPCa detection attributable to mUS will be assessed by describing csPCa detected in mUS-targeted cores and comparing detection patterns relative to mpMRI findings (negative vs stable findings) and other clinical parameters.
Agreement between mpMRI and mUS lesion identification will be assessed using appropriate concordance metrics (e.g., Cohen's kappa) when applicable.
-Safety outcomes will include biopsy-related adverse events, including infectious complications, urinary retention, bleeding events, pain, and other procedure-related outcomes. Adverse events will be collected prospectively and categorized according to standardized definitions, and clinically relevant complications will be graded using established severity classifications (e.g., Clavien-Dindo).
Statistical Considerations Diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV) will be reported with confidence intervals. The study's two-stage phase II design provides an efficient approach to determining whether mUS demonstrates adequate diagnostic performance for csPCa detection in this clinically important subgroup of men with negative or stable mpMRI findings. Interim analysis will be performed after completion of Stage 1 enrollment and histopathology outcomes, with progression to Stage 2 contingent on meeting the predefined performance threshold.
Clinical Significance This study addresses an unmet need within the AS pathway: improving detection of csPCa in men with negative or stable mpMRI who remain at risk of harboring higher-grade disease. If mUS demonstrates high sensitivity and useful NPV, it may support improved risk stratification, reduce missed csPCa, and optimize biopsy decision-making. The findings may inform future diagnostic strategies and pathway refinement, including how mUS can be integrated with mpMRI in AS and early detection settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm diagnostic study in which all participants undergo micro-ultrasound assessment. Participants with PRI-MUS ≥3 lesions receive targeted biopsy, and all participants undergo systematic 12-core biopsy during the same session.
| Arm | Type | Receives |
|---|---|---|
| Micro-Ultrasound Imaging and Biopsy | Experimental | Diagnostic Test: Micro-Ultrasound (mUS)All participants will undergo micro-ultrasound prostate assessment. If a suspicious lesion is identified, targeted biopsy will be performed. All participants will also undergo a 12-core systematic biopsy during the same session. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male participants aged 45 to 75 years
- Localized prostate cancer on active surveillance or newly diagnosed and eligible for active surveillance
- Negative multiparametric MRI (PI-RADS ≤2) or stable mpMRI findings on surveillance
- Prior prostate biopsy showing Grade Group 1, or Grade Group 2 (Gleason 3+4) with ≤10% pattern 4
- PSA ≤15 ng/mL
Key exclusion criteria (5 listed)
- Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy)
- Prior prostate surgery that may affect biopsy or imaging interpretation
- Contraindication to prostate biopsy
- Active urinary tract infection or prostatitis
- Inability to tolerate the biopsy procedure or follow study procedures
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 |
|---|---|---|
| Micro-Ultrasound (mUS)High-frequency micro-ultrasound prostate imaging with real-time lesion assessment. Targeted biopsy of suspicious lesions will be performed when present, along with concurrent systematic 12-core biopsy. | Diagnostic test | Micro-Ultrasound Imaging and Biopsy |
Primary outcome
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Time frame: At the time of the study biopsy procedure (baseline)
Sensitivity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
Specificity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Time frame: At the time of the study biopsy procedure (baseline)
Specificity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
5 secondary outcomes
Positive Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Time frame: At the time of the study biopsy procedure (baseline)
Negative Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Time frame: At the time of the study biopsy procedure (baseline)
Overall Diagnostic Accuracy of Micro-Ultrasound for csPCa (Grade Group ≥2)
Time frame: At the time of the study biopsy procedure (baseline)
Incremental Detection of csPCa Using Micro-Ultrasound Targeted Biopsy
Time frame: At the time of the study biopsy procedure (baseline)
Concordance Between Micro-Ultrasound Findings and mpMRI Findings
Time frame: At the time of the study biopsy procedure (baseline)
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 4 Feb 2026.
- Background: PubMed 35252092Wang L, Lu B, He M, Wang Y, Wang Z, Du L. Prostate Cancer Incidence and Mortality: Global Status and Temporal Trends in 89 Countries From 2000 to 2019. Front Public Health. 2022 Feb 16;10:811044. doi: 10.3389/fpubh.2022.811044. eCollection 2022.
- Background: PubMed 28110982Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
- Background: PubMed 36325366Albers P, Wang B, Broomfield S, Medina Martin A, Fung C, Kinnaird A. Micro-ultrasound Versus Magnetic Resonance Imaging in Prostate Cancer Active Surveillance. Eur Urol Open Sci. 2022 Oct 25;46:33-35. doi: 10.1016/j.euros.2022.09.019. eCollection 2022 Dec.
- Background: PubMed 38587980Albers P, Bennett J, Evans M, St Martin E, Wang B, Broomfield S, Martin AM, Tu W, Fung C, Kinnaird A. Micro-ultrasound for the detection of clinically significant prostate cancer in biopsy-naive men with negative MRI. Can Urol Assoc J. 2024 Jun;18(6):208-211. doi: 10.5489/cuaj.8626.
- Background: PubMed 40121537Kinnaird A, Luger F, Cash H, Ghai S, Urdaneta-Salegui LF, Pavlovich CP, Brito J, Shore ND, Struck JP, Schostak M, Harland N, Rodriguez-Socarras M, Brisbane WG, Lughezzani G, Toledano H, Ouertani MS, Macek P, Fung C, Tu W, Gusenleitner A, Gunzel K, Incze PF, George AK, Pereira JG, Jansen R, Renzulli J 2nd, Klotz L; OPTIMUM Investigators. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. 2025 May 20;333(19):1679-1687. doi: 10.1001/jama.2025.3579.
- Background: PubMed 36831622Basso Dias A, Ghai S. Micro-Ultrasound: Current Role in Prostate Cancer Diagnosis and Future Possibilities. Cancers (Basel). 2023 Feb 17;15(4):1280. doi: 10.3390/cancers15041280.
- Background: PubMed 34230862Scott R, Misser SK, Cioni D, Neri E. PI-RADS v2.1: What has changed and how to report. SA J Radiol. 2021 Jun 1;25(1):2062. doi: 10.4102/sajr.v25i1.2062. eCollection 2021.
- Background: PubMed 31326219Drost FH, Osses D, Nieboer D, Bangma CH, Steyerberg EW, Roobol MJ, Schoots IG. Prostate Magnetic Resonance Imaging, with or Without Magnetic Resonance Imaging-targeted Biopsy, and Systematic Biopsy for Detecting Prostate Cancer: A Cochrane Systematic Review and Meta-analysis. Eur Urol. 2020 Jan;77(1):78-94. doi: 10.1016/j.eururo.2019.06.023. Epub 2019 Jul 18.
- Background: PubMed 31647166Klotz L. Active surveillance in intermediate-risk prostate cancer. BJU Int. 2020 Mar;125(3):346-354. doi: 10.1111/bju.14935. Epub 2020 Jan 16.
- Background: PubMed 31918957Tosoian JJ, Mamawala M, Epstein JI, Landis P, Macura KJ, Simopoulos DN, Carter HB, Gorin MA. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Eur Urol. 2020 Jun;77(6):675-682. doi: 10.1016/j.eururo.2019.12.017. Epub 2020 Jan 7.
- Background: PubMed 38614820Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Brunckhorst O, Darraugh J, Eberli D, De Meerleer G, De Santis M, Farolfi A, Gandaglia G, Gillessen S, Grivas N, Henry AM, Lardas M, van Leenders GJLH, Liew M, Linares Espinos E, Oldenburg J, van Oort IM, Oprea-Lager DE, Ploussard G, Roberts MJ, Rouviere O, Schoots IG, Schouten N, Smith EJ, Stranne J, Wiegel T, Willemse PM, Tilki D. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024 Aug;86(2):148-163. doi: 10.1016/j.eururo.2024.03.027. Epub 2024 Apr 13.
- Background: PubMed 35536144Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, Eggener S, Horwitz EM, Kane CJ, Kirkby E, Lin DW, McBride SM, Morgans AK, Pierorazio PM, Rodrigues G, Wong WW, Boorjian SA. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, Part I: Introduction, Risk Assessment, Staging, and Risk-Based Management. J Urol. 2022 Jul;208(1):10-18. doi: 10.1097/JU.0000000000002757. Epub 2022 May 10.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participant privacy and confidentiality. De-identified data may be made available upon reasonable request and subject to institutional approvals and applicable ethics requirements.
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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.
Maurice Anidjar, MD, PhD study chair
Jewish General Hospital
Rafael Sanchez-Salas, MD principal investigator
McGill Universiy Health Center // Jewish General Hospital
Rocio Roldan-Testillano, MD study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-Ultrasound (mUS) in people with Prostate Cancer and Active Surveillance for Prostate Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 9 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: opening soon, as of the sponsor's last update on 4 Feb 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 Canada. 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?
Contact Rocio Roldan-Testillano, MD (4388285227 ext. Urology, rocio.roldan@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2) (time frame: At the time of the study biopsy procedure (baseline)). The study lists 2 primary outcomes in all. 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 NCT07386171, which also lists 12 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 4 Feb 2026.