Clareo Health | Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
