Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517901
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Status:
NOT_YET_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:
FOCUS-PC
Brief Summary:
The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques
1 Software-based fusion of MRI and ultrasound images software fusion or
2 Visually estimated MRI-informed cognitive fusion technique
To date there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI mp-MRI of prostate
1 Software-based fusion of MRI and ultrasound images software fusion or
2 Visually estimated MRI-informed cognitive fusion technique
To date there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI mp-MRI of prostate
Detailed Description:
For prostate cancer detection pre-biopsy multi-parametric magnetic resonance imaging mp-MRI followed by MRI-targeted prostate biopsy is standard of care which is supported by the guidelines from the American Urological Association and the European Association of Urology The MRI-targeted prostate biopsy is associated with a significant increase in the detection of clinically significant prostate cancer csPCa compared to the ultrasound guided biopsy The MRI-targeted biopsy can be performed using one of two techniques including software-based fusion of MRI and ultrasound images software fusion or visually guided MRI-informed cognitive fusion technique
With regards to the diagnostic performance in detecting csPCa current literature does not demonstrate a clear advantage to one targeting technique over the other A systematic review and meta-analysis published in early 2024 by Falagario et al evaluated all of the comparative studies of the above-mentioned MRI-targeting techniques Of the 20 studies included six reported improved detection of csPCa with fusion technique one reported an advantage to the cognitive technique while thirteen reported no significant difference Of note the majority of the studies were retrospective with high risk of bias that lacked uniform definition of csPCa and employed variable mp-MRI technique 15T vs 3T and scoring system Likert vs PIRADS There were only three small prospective randomized studies RCT available in the systematic review of literature One RCT reported the fusion technique to be superior while two demonstrated no difference in csPCa detection rates There was no significant difference in the detection of csPCa between the targeting techniques however low quality of evidence and heterogeneity warranted well-designed prospective studies
Other studies as well as personal experience point to somewhat improved cancer detection the cognitive MRI-targeting approach although the rates may be affected by patient selection related to lesion size and location
Thus the investigators are conducting an RCT to direct compare the csPCa detection rates following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on mp-MRI of prostate The investigators hypothesize that the diagnostic accuracy MRI-targeted prostate biopsy using cognitive fusion technique is either similar to or not significantly inferior to the software fusion technique
With regards to the diagnostic performance in detecting csPCa current literature does not demonstrate a clear advantage to one targeting technique over the other A systematic review and meta-analysis published in early 2024 by Falagario et al evaluated all of the comparative studies of the above-mentioned MRI-targeting techniques Of the 20 studies included six reported improved detection of csPCa with fusion technique one reported an advantage to the cognitive technique while thirteen reported no significant difference Of note the majority of the studies were retrospective with high risk of bias that lacked uniform definition of csPCa and employed variable mp-MRI technique 15T vs 3T and scoring system Likert vs PIRADS There were only three small prospective randomized studies RCT available in the systematic review of literature One RCT reported the fusion technique to be superior while two demonstrated no difference in csPCa detection rates There was no significant difference in the detection of csPCa between the targeting techniques however low quality of evidence and heterogeneity warranted well-designed prospective studies
Other studies as well as personal experience point to somewhat improved cancer detection the cognitive MRI-targeting approach although the rates may be affected by patient selection related to lesion size and location
Thus the investigators are conducting an RCT to direct compare the csPCa detection rates following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on mp-MRI of prostate The investigators hypothesize that the diagnostic accuracy MRI-targeted prostate biopsy using cognitive fusion technique is either similar to or not significantly inferior to the software fusion technique
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