NCT05043012 Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
| NCT ID | NCT05043012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2022-07-18 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 258 participants in total. It began in 2022-07-18 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<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.
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.
Contact & Investigator
Tharakeswara Bathala, MBBS,MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05043012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05043012 currently recruiting?
Yes, NCT05043012 is actively recruiting participants. Contact the research team at TKBathala@mdanderson.org for enrollment information.
Where is the NCT05043012 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05043012 clinical trial?
NCT05043012 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Tharakeswara Bathala, MBBS,MD at M.D. Anderson Cancer Center. The trial plans to enroll 258 participants.
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