Prostate CancerNCT05043012
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
A study testing flexible AIR coil and endorectal coi in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- flexible AIR coil and endorectal coi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tharakeswara Bathala, MBBS,MD, tkbathala@mdanderson.org
About this study
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.
Read the detailed description
Primary Objective:
To compare the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI (Group 1: Control) versus patients who undergo non-ERC mpMRI with flexible AIR coil technology (Group 2: Experimental).
Secondary Objective:
- To compare the scanning time and room time in Group 1 versus Group 2.
- To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).
- To determine the impact of mpMRI on treatment planning for men with intermediate and high-risk prostate cancer and compare management impact in Group 1 versus Group 2
- To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.
- Conditions
- Prostate Cancer
- Being tested
- flexible AIR coil, endorectal coi
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible AIR coilDevice
mpMRI scan
endorectal coiDevice
mpMRI scan
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | will have an mpMRI scan with a flexible AIR coil. Receives: Device: flexible AIR coil |
| Group 2 | Experimental | will have an mpMRI scan with an endorectal coil Receives: Device: endorectal coi |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start18 Jul 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tharakeswara Bathala, MBBS,MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043012
- Sponsor's protocol ID
- 2020-1044
- Other IDs
- NCI-2021-09414
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
- ClinicalTrials.gov ID
- NCT05043012
- Acronym / sponsor ID
- 2020-1044
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
To compare the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI (Group 1: Control) versus patients who undergo non-ERC mpMRI with flexible AIR coil technology (Group 2: Experimental).
Secondary Objective:
- To compare the scanning time and room time in Group 1 versus Group 2.
- To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).
- To determine the impact of mpMRI on treatment planning for men with intermediate and high-risk prostate cancer and compare management impact in Group 1 versus Group 2
- To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: flexible AIR coilwill have an mpMRI scan with a flexible AIR coil. |
| Group 2 | Experimental | Device: endorectal coiwill have an mpMRI scan with an endorectal coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible AIR coilmpMRI scan | Device | Group 1 |
| endorectal coimpMRI scan | Device | Group 2 |
Primary outcome
To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tharakeswara Bathala, MBBS,MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible AIR coil and endorectal coi in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tharakeswara Bathala, MBBS,MD ((713) 792-2533, TKBathala@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.