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

NCT05043012 | Recruiting

• 2 other identifiers: 2020-1044NCI-2021-09414
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To correlate the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI

  through study completion, an average of 1 year

Study Arms (2)

Group 1

EXPERIMENTAL

will have an mpMRI scan with a flexible AIR coil.

Device: flexible AIR coil

Group 2

EXPERIMENTAL

will have an mpMRI scan with an endorectal coil

Device: endorectal coi

Interventions

flexible AIR coil DEVICE

mpMRI scan

Group 1

endorectal coi DEVICE

mpMRI scan

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tharakeswara Bathala, MBBS,MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tharakeswara Bathala, MBBS,MD

CONTACT

(713) 792-2533; TKBathala@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: July 18, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)