Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584279
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer a Prospective Multicenter Paired Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer Despite its widespread use this method is characterized by a high volume of needle biopsies A refined approach termed targeted and index-lesion-ipsilateral systematic biopsy as one of targeted and regional systematic biopsy methods aim to reduce the number of biopsy cores while maintaining an adequate positive rate However the absence of robust evidence necessitates further investigation This study employs a prospective multicenter paired non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer csPCa Eligible participants were identified as those with target lesions on prostate MRI who subsequently underwent targeted and systematic prostate biopsies The index lesion was defined as the one with the highest Prostate Imaging Reporting and Data System PI-RADS score in cases of multiple lesions with identical PI-RADS scores the lesion with the greatest diameter was prioritized Post-biopsy pathological data were collected and evaluated using the International Society of Urological Pathology ISUP grading system which classifies patients with a grade of 2 or higher as having csPCa The studys primary outcome was to calculate the confidence interval for the difference in csPCa detection rates between the two biopsy methods under a paired design This interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting csPCa
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None