Actively Recruiting
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
258
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, Age 218
- Untreated, biopsy-proven intermediate and high-risk (Gleason group grade 2/2) adenocarcinoma of the prostate
- Planned curative-intent radical prostatectomy within 6 months of mpMRI
- Provided written informed consent
- Eligible for scanning at 3 Tesla magnet
You will not qualify if you...
- Low-risk adenocarcinoma of the prostate
- Prior prostate cancer treatment
- Other active malignancy within past 2 years
- Prostate cancer with sarcomatoid, spindle cell, or neuroendocrine small cell features
- Presence of cardiac pacemaker
- Orthopedic hardware in pelvis or spine
- Claustrophobia or need for anesthesia
- Contraindications for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, or absence of rectum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tharakeswara Bathala, MBBS,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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