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Micro-ultrasound for Prostate Cancer Diagnosis

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ClinicalTrials.gov Identifier: NCT04832997
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Alberto Briganti, IRCCS San Raffaele

Brief Summary:

This is a monocentre, 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 postitive 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Every patient will receive the same diagnostic test (MRI and Micro-US) in a randomized sequence
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Micro-ultrasound or MRI-targeted Biopsy for Prostate Cancer Diagnosis
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI [ Time Frame: through study completation, an average time of 2 years ]
    To compare the sensitivity in detecting clinically significant prostate cancer of Micro-US vs. mpMRI


Secondary Outcome Measures :
  1. Proportion of clinically significant prostate cancer detected with the inclusion of Micro-US within the diagnostic pathway of prostate cancer [ Time Frame: through study completation, an average time of 2 years ]
    To report the diagnostic benefit related with the use of Micro-US in the prostate cancer diagnostic pathway

  2. Proportion of men with clinically insignificant prostate cancer detected by MRI-TBx vs. Micro-US-TBx [ Time Frame: through study completation, an average time of 2 years ]
  3. Proportion of men with at least one lesion detected by mpMRI vs. Micro-US [ Time Frame: through study completation, an average time of 2 years ]
  4. Proportion of men with clinically significant prostate cancer detected by Micro-US-TBx missed by MRI-TBx and vice-versa [ Time Frame: through study completation, an average time of 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832997


Contacts
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Contact: Marta Picozzi +390226436268 picozzi.marta@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Marta Picozzi    +390226436268    picozzi.marta@hsr.it   
Principal Investigator: Alberto Briganti, Prof         
Sub-Investigator: Armando Stabile, MD         
Sub-Investigator: Gabriele Sorce, MD         
Sponsors and Collaborators
IRCCS San Raffaele
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Responsible Party: Prof. Alberto Briganti, Full Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04832997    
Other Study ID Numbers: US-MIRROR
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases