Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)

NCT ID: NCT05043012

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2027-02-02

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.

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:

1. To compare the scanning time and room time in Group 1 versus Group 2.

2. To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).

3. 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

4. To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1

will have an mpMRI scan with a flexible AIR coil.

Group Type: EXPERIMENTAL

flexible AIR coil

Intervention Type: DEVICE

mpMRI scan

Group 2

will have an mpMRI scan with an endorectal coil

Group Type: EXPERIMENTAL

endorectal coi

Intervention Type: DEVICE

mpMRI scan

Interventions

flexible AIR coil

mpMRI scan

Intervention Type: DEVICE

endorectal coi

mpMRI scan

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tharakeswara Bathala, MBBS,MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tharakeswara Bathala, MBBS,MD

Role: CONTACT

TKBathala@mdanderson.org

(713) 792-2533

Facility Contacts

Tharakeswara Bathala, MBBS,MD

Role: primary

tkbathala@mdanderson.org

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-09414

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-1044

Identifier Type: -

Identifier Source: org_study_id