NCT05043012Recruiting
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 24 Aug 2021
- Start date
- 18 Jul 2022
- Primary completion date
- 2 Feb 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT05043012
What you commit to
- Study type: Interventional
- Planned participants: 258
- From 18 Jul 2022 to the primary completion date, 2 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has had any prior therapy for prostate cancer
- Claustrophobia and/or receiving anesthesia
Other illness
- 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
- Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.
Other
- Low-risk adenocarcinoma of prostate
- Orthopedic hardware in the pelvis and spine.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.