Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Recruiting · NCT05043012 · Interventional (participants receive a specific treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States