Micro-ultrasound for Prostate Cancer Diagnosis

NCT04832997 | Terminated

• 1 other identifier: US-MIRROR
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of clinically significant prostate cancer detected with the inclusion of Micro-US within the diagnostic pathway of prostate cancer

  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

Study Arms (1)

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.

Diagnostic Test: Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)

Interventions

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.

mpMRI plus Micro-US

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

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 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: Full Professor

Model Details: Every patient will receive the same diagnostic test (MRI and Micro-US) in a randomized sequence

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 6, 2021
• Study Start: September 14, 2020
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

IT (1)