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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09414 | Registry Identifier | CTRP (Clinical Trial Reporting Program |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | will have an mpMRI scan with a flexible AIR coil. |
|
| Group 2 | Experimental | will have an mpMRI scan with an endorectal coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flexible AIR coil | Device | mpMRI scan |
| |
| endorectal coi |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tharakeswara Bathala, MBBS,MD | Contact | (713) 792-2533 | TKBathala@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Tharakeswara Bathala, MBBS,MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Device |
mpMRI scan |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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