Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
flexible AIR coil
endorectal coi
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Male, Age ≥ 18
- Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade >/=2) adenocarcinoma of the prostate
- Patient is being considered for curative-intent treatment with radical prostatectomy within 6 months following mpMRI
- Patient has provided written informed consent for participation in this trial
- Patient should be eligible for scanning at 3 T magnet
Exclusion Criteria:
- Low-risk adenocarcinoma of prostate
- Patient has had any prior therapy for prostate cancer
- A history of other active malignancy within the last 2 years
- Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
- Cardiac pacemaker
- Orthopedic hardware in the pelvis and spine.
- Claustrophobia and/or receiving anesthesia
- Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.
Sites / Locations
- The University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
will have an mpMRI scan with a flexible AIR coil.
will have an mpMRI scan with an endorectal coil
Outcomes
Primary Outcome Measures
To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI
Secondary Outcome Measures
Full Information
NCT ID
NCT05043012
First Posted
August 24, 2021
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05043012
Brief Title
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Official Title
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
To compare the scanning time and room time in Group 1 versus Group 2.
To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).
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
To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
will have an mpMRI scan with a flexible AIR coil.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
will have an mpMRI scan with an endorectal coil
Intervention Type
Device
Intervention Name(s)
flexible AIR coil
Intervention Description
mpMRI scan
Intervention Type
Device
Intervention Name(s)
endorectal coi
Intervention Description
mpMRI scan
Primary Outcome Measure Information:
Title
To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male, Age ≥ 18
Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade >/=2) adenocarcinoma of the prostate
Patient is being considered for curative-intent treatment with radical prostatectomy within 6 months following mpMRI
Patient has provided written informed consent for participation in this trial
Patient should be eligible for scanning at 3 T magnet
Exclusion Criteria:
Low-risk adenocarcinoma of prostate
Patient has had any prior therapy for prostate cancer
A history of other active malignancy within the last 2 years
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
Cardiac pacemaker
Orthopedic hardware in the pelvis and spine.
Claustrophobia and/or receiving anesthesia
Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tharakeswara Bathala, MBBS,MD
Phone
(713) 792-2533
Email
TKBathala@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala, MBBS,MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala, MBBS,MD
Email
tkbathala@mdanderson.org
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
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