Prostate Cancer
Conditions
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.
Detailed 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.
Interventions
DEVICEflexible AIR coil
mpMRI scan
DEVICEendorectal coi
mpMRI scan
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
CONTACTTharakeswara Bathala, MBBS,MD
PRINCIPAL_INVESTIGATORTharakeswara Bathala, MBBS,MD
M.D. Anderson Cancer Center
Outcome results
None listed