Clinical trial · Interventional
Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Surveillance for Prostate Cancer | — | UNRESOLVED | — |
| Imaging Techniques | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Micro-Ultrasound (mUS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Micro-Ultrasound Imaging and Biopsy
- description
- 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.
- interventionNames
- Diagnostic Test: Micro-Ultrasound (mUS)
Primary outcomes (2)
- measure
- Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
- timeFrame
- At the time of the study biopsy procedure (baseline)
- description
- 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.
- measure
- Specificity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Clinical stage ≤T2a * Life expectancy \>10 years * Ability to provide written informed consent and comply with study procedures Exclusion Criteria: * 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
References
Publications (12)
- BACKGROUNDWang 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. PMID 35252092
- BACKGROUNDAhmed 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. PMID 28110982
- BACKGROUNDAlbers 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. PMID 36325366
- BACKGROUNDAlbers 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. PMID 38587980
- BACKGROUNDKinnaird 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. PMID 40121537
- BACKGROUNDBasso 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.