Recruiting

Multiparametric MRI

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05043012

Conditions

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

flexible AIR coil

endorectal coi

Study Details

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

Study ID

NCT05043012

Start date

Jul 18, 2022

Status verified date

Aug, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

258 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

flexible AIR coil

mpMRI scan

endorectal coi

mpMRI scan

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 and Locations

Central contacts

Tharakeswara Bathala, MBBS,MD

(713) 792-2533TKBathala@mdanderson.org

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Tharakeswara Bathala, MBBS,MD

tkbathala@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-14.