Micro-ultrasound for Prostate Cancer Diagnosis

Prostate Cancer Clinical Trial

Official title:

Micro-ultrasound or MRI-targeted Biopsy for Prostate Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832997
• Other study ID #: US-MIRROR
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2021
• Source: IRCCS San Raffaele
• Contact: Marta Picozzi
• Phone: +390226436268
• Email: picozzi.marta[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of men with at least one lesion detected by mpMRI vs. Micro-US		through study completation, an average time of 2 years
Secondary	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