Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance

NCT07386171 | Not Yet Recruiting

• 1 other identifier: MUHC-MICROUS-AS-2026-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Prostate Cancer; Active Surveillance for Prostate Cancer; Imaging Techniques

Keywords

Active Surveillance Prostate Cancer; Prostate Cancer Imaging; Micro-ultrasound; Multiparametric MRI; Clinically significant prostate cancer; Targeted-Systematic biopsy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the time of the study biopsy procedure (baseline)

Secondary Outcomes (5)

• Positive Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)

  At the time of the study biopsy procedure (baseline)

• Negative Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)

  At the time of the study biopsy procedure (baseline)

• Overall Diagnostic Accuracy of Micro-Ultrasound for csPCa (Grade Group ≥2)

  At the time of the study biopsy procedure (baseline)

• Incremental Detection of csPCa Using Micro-Ultrasound Targeted Biopsy

  At the time of the study biopsy procedure (baseline)

• Concordance Between Micro-Ultrasound Findings and mpMRI Findings

  At the time of the study biopsy procedure (baseline)

Other Outcomes (1)

• Biopsy-Related Adverse Events

  Up to 30 days post-biopsy

Study Arms (1)

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.

Diagnostic Test: Micro-Ultrasound (mUS)

Interventions

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.

Micro-Ultrasound Imaging and Biopsy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Eligible participants are individuals with a prostate who meet all study inclusion and exclusion criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (12)

• 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.

  PMID: 35252092 BACKGROUND

• Ahmed 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 BACKGROUND

• Albers 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 BACKGROUND

• Albers 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 BACKGROUND

• Kinnaird 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 BACKGROUND

• Basso 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.

  PMID: 36831622 BACKGROUND

• Scott 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.

  PMID: 34230862 BACKGROUND

• Drost 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.

  PMID: 31326219 BACKGROUND

• Klotz 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.

  PMID: 31647166 BACKGROUND

• Tosoian 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.

  PMID: 31918957 BACKGROUND

• Cornford 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.

  PMID: 38614820 BACKGROUND

• Eastham 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.

  PMID: 35536144 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maurice Anidjar, MD, PhD

  Jewish General Hospital

  STUDY CHAIR

• Rafael Sanchez-Salas, MD

  McGill Universiy Health Center // Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Rocio Roldan-Testillano, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  STUDY DIRECTOR

Central Study Contacts

Rocio Roldan-Testillano, MD

CONTACT

4388285227; rocio.roldan@mcgill.ca

Claudia Covarrubias, MD

CONTACT

(514) 340-8222; claudia.covarrubias@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)