Comparing MRI techniques for detecting prostate cancer
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
This study is testing a new type of MRI scan to see if it can find prostate cancer better than the traditional method in men at higher risk for the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05043012 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of non-endorectal coil multiparametric MRI (mpMRI) using flexible AIR coil technology against traditional endorectal coil mpMRI in detecting clinically significant prostate cancer in men with intermediate and high-risk disease. The primary objective is to compare the detection rates of Gleason Group grade ≥ 2 disease between the two groups. Additionally, the study will assess scanning times, patient-reported outcomes, and the impact of mpMRI on treatment planning. The goal is to improve diagnostic accuracy and reduce unnecessary procedures.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with untreated, biopsy-proven intermediate and high-risk prostate cancer.
Not a fit: Patients with low-risk prostate cancer or those who have received prior therapy for prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis and reduce unnecessary biopsies for patients.
How similar studies have performed: Previous studies have shown promising results with mpMRI in prostate cancer detection, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Tharakeswara Bathala, MBBS,MD — M.D. Anderson Cancer Center
- Study coordinator: Tharakeswara Bathala, MBBS,MD
- Email: TKBathala@mdanderson.org
- Phone: (713) 792-2533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.