Micro-ultrasound for Prostate Cancer Diagnosis

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: mpMRI plus Micro-US; 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.

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completation, an average time of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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		through study completation, an average time of 2 years
Proportion of men with at least one lesion detected by mpMRI vs. Micro-US		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		through study completation, an average time of 2 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): July 16, 2025

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: US-MIRROR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No