Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05043012
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2021-08-24
Brief Title:
Diagnostic Performance of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging of Prostate with Flexible AIR Coil DoNEMAC Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Diagnostic Performance of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging of Prostate with Flexible AIR Coil DoNEMAC Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiparametric MRI mpMRI of the prostate is an important tool for diagnosis of clinically significant prostate cancer csPCa in men with an elevated serum prostate specific antigen which can decrease the rate of unnecessary biopsies and reduce the incidence of over-diagnosis of non-csPCa Furthermore there is evidence that MRI is more accurate in detecting high-grade Gleason grade group 3 versus low grade cancers Gleason grade group 2 and therefore may serve as a useful adjunct to prostate-specific antigen PSA testing digital rectal examination and prostatic biopsy to detect cancers that require definitive treatment as opposed to active surveillance Many investigators including our group have shown the utility of preoperative mpMRI to assess the local extent of prostate cancer and for surgical planning
Detailed Description:
Primary Objective
To compare the detection rate of Gleason Group grade 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI Group 1 Control versus patients who undergo non-ERC mpMRI with flexible AIR coil technology Group 2 Experimental
Secondary Objective
1 To compare the scanning time and room time in Group 1 versus Group 2
2 To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index TMI
3 To determine the impact of mpMRI on treatment planning for men with intermediate and high-risk prostate cancer and compare management impact in Group 1 versus Group 2
4 To compare the detection rate of T3 disease on MRI confirmed by histopathology at prostatectomy between Group 1 versus Group 2
To compare the detection rate of Gleason Group grade 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI Group 1 Control versus patients who undergo non-ERC mpMRI with flexible AIR coil technology Group 2 Experimental
Secondary Objective
1 To compare the scanning time and room time in Group 1 versus Group 2
2 To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index TMI
3 To determine the impact of mpMRI on treatment planning for men with intermediate and high-risk prostate cancer and compare management impact in Group 1 versus Group 2
4 To compare the detection rate of T3 disease on MRI confirmed by histopathology at prostatectomy between Group 1 versus Group 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-09414 | REGISTRY | CTRP Clinical Trial Reporting Program | None |