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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05043012
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • flexible AIR coil — DEVICE
    mpMRI scan
  • endorectal coi — DEVICE
    mpMRI scan

Study Details

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.

Key Dates

Start date
Jul 18, 2022
Status verified
Mar 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
258 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Group 1
    will have an mpMRI scan with a flexible AIR coil.
  • Experimental: Group 2
    will have an mpMRI scan with an endorectal coil

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Tharakeswara Bathala, MBBS,MD
[email protected]

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
The University of Texas MD Anderson Cancer Center· Houston, TX

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