Non-Endorectal Coil Multiparametric MRI Scan with Flexible AIR Coil Technology for the Detection of Prostate Cancer, DoNEMAC Study

Status: active

This phase III clinical trial compares non-endorectal coil multiparametric magnetic resonance imaging (mpMRI) with flexible adaptive image receiver (AIR) coil technology to standard endorectal coil mpMRI in detecting prostate cancer. Endorectal coil device is inserted into the rectum before MRI. Flexible AIR coil technology is a device that looks like a small mat or blanket and placed on the pelvis before MRI. This study is being done to find if non-endorectal coil mpMRI with flexible AIR coil technology has the same detection rate as standard endorectal coil mpMRI.

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

PRIMARY OBJECTIVE:

I. To compare the detection rate of Gleason Group grade >= 2 disease in patients with intermediate and high-risk prostate cancer who undergo endorectal coil (ERC) mpMRI (Group I: Control) versus patients who undergo non-ERC mpMRI with flexible AIR coil technology (Group 2: Experimental).

SECONDARY OBJECTIVES:

I. To compare the scanning time and room time in Group 1 versus Group 2.

II. To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).

III. 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.

IV. To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.

V. To compare biochemical recurrence-free survival between Group 1 versus Group 2.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo ERC mpMRI over 60-90 minutes.

GROUP II: Patients undergo non-ERC mpMRI with flexible AIR coil technology over 60-90 minutes.

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Non-Endorectal Coil Multiparametric MRI Scan with Flexible AIR Coil Technology for the Detection of Prostate Cancer, DoNEMAC Study

Inclusion Criteria

Exclusion Criteria

United States

Texas

Houston

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Non-Endorectal Coil Multiparametric MRI Scan with Flexible AIR Coil Technology for the Detection of Prostate Cancer, DoNEMAC Study

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