Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579911
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does It Increase the Detection Rate of Clinically Significant Prostate Cancer a Prospective Interventional Single Centre Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Biopsy29
Brief Summary:
Study Goal The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods This study is aimed at men who may have prostate cancer
Main Questions the Study Aims to Answer
1 Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method
2 Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects
Participation in the Study
Participants in this study will undergo the following procedures
A high-frequency micro-ultrasound examination of the prostate
A multiparametric MRI-targeted biopsy of the prostate
A systematic biopsy of the prostate
Comparison Group Researchers will compare the new combination method with the current standard method to see if the new approach is more effective
Participants will
Undergo several exams and biopsies depending on the results of previous tests
Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health
Record their experiences and any symptoms in a diary
Main Questions the Study Aims to Answer
1 Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method
2 Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects
Participation in the Study
Participants in this study will undergo the following procedures
A high-frequency micro-ultrasound examination of the prostate
A multiparametric MRI-targeted biopsy of the prostate
A systematic biopsy of the prostate
Comparison Group Researchers will compare the new combination method with the current standard method to see if the new approach is more effective
Participants will
Undergo several exams and biopsies depending on the results of previous tests
Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health
Record their experiences and any symptoms in a diary
Detailed Description:
The primary objective of this study is i to demonstrate that the combination of highfrequency micro-ultrasound target biopsy multiparametric MRI target biopsy and systematic biopsy detects more clinically significant prostate cancer ISUP 2 than multiparametric MRI target biopsy and systematic biopsy alone current standard of care
The secondary objective of this study is ii to demonstrate that the combination of high frequency micro-ultrasound target biopsy multiparametric MRI target biopsy and systematic biopsy does not detect more clinically insignificant prostate cancer ISUP 1 than multiparametric MRI target biopsy and systematic biopsy alone current standard of care
The third objective of this study is iii to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer ISUP 2 than multiparametric MRI target biopsy and systematic biopsy current standard of care
The fourth objective of this study is iv to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer ISUP 1 than the combination of multiparametric MRI target biopsy and systematic biopsy current standard of care
The secondary objective of this study is ii to demonstrate that the combination of high frequency micro-ultrasound target biopsy multiparametric MRI target biopsy and systematic biopsy does not detect more clinically insignificant prostate cancer ISUP 1 than multiparametric MRI target biopsy and systematic biopsy alone current standard of care
The third objective of this study is iii to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer ISUP 2 than multiparametric MRI target biopsy and systematic biopsy current standard of care
The fourth objective of this study is iv to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer ISUP 1 than the combination of multiparametric MRI target biopsy and systematic biopsy current standard of care
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