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Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
NCT05043012 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this 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.
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.
Study design
Enrollment target: 258 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-07-18
Estimated completion: 2027-02-02
Last updated: 2026-03-05
Interventions
Device: flexible AIR coilDevice: endorectal coi
Primary outcomes
- • To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI (through study completion, an average of 1 year)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactTharakeswara Bathala, MBBS,MD · contact · TKBathala@mdanderson.org · (713) 792-2533
InvestigatorTharakeswara Bathala, MBBS,MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States