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Recruiting
NCT05043012
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Conditions: Prostate Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 258
Sponsor: M.D. Anderson Cancer Center
Location: The University of Texas MD Anderson Cancer Center Houston Texas
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 \
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.
Source: ClinicalTrials.gov (NCT05043012). StuddyBuddy aggregates publicly available trial information.