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Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05043012
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Tharakeswara Bathala
Phone 713-792-2533
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 30, 2021
Completion date December 31, 2022

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