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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043012
• Other study ID #: 2020-1044
• Secondary ID: NCI-2021-09414
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: February 2, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Tharakeswara Bathala, MBBS,MD
• Phone: (713) 792-2533
• Email: TKBathala[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• flexible AIR coil
mpMRI scan
• endorectal coi
mpMRI scan

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center