Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer

OBJECTIVES:

Primary

- Determine the test-retest performance, assessed by the repeatability coefficient [RC] of
K^trans and gadolinium curve (IAUGC90^bn) and measured by median pixel values of the
whole prostate.

- Determine the test-retest performance, assessed by the RC of diffusion-weighted imaging
(DWI) metrics D(t) and measured by median pixel values of the whole prostate.

Secondary

- Determine the test-retest performance, assessed by RC of K^trans, IAUGC90^bn, and D(t),
and measured by median pixel values of the dominant prostate tumor.

- Determine the effect of reader on the RC of dynamic contrast-enhanced magnetic resonance
imaging (DCE-MRI) and DWI metrics for whole prostate and tumor nodule target lesion.

- Determine whether T1-dependent or T1-independent methods for gadolinium quantification
in DCE-MRI studies produce differing values for the RC for K^trans and IAUGC90^bn.

- Explore the correlation between DCE-MRI and DWI metrics for both whole prostate and
dominant tumor nodule as target lesions. (Exploratory)

- Determine whether the "coffee break" approach toward test-retest analysis of
quantitative DWI provides a reasonable estimate of the RC of D(t)of the whole prostate,
using as the gold standard the RC of D(t) obtained between the two separate MRI visits.
(Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to MRI vendor used
(Siemens vs GE vs Philips).

Patients receive gadolinium-based contrast IV and undergo DCE-MRI* and DWI 2 imaging at 2-14
days apart prior to treatment initiation. A central reader evaluation of the 2 successive
scans is then conducted.

NOTE: *At the discretion of the participating sites, the initial MRI visit (MRI SCAN 1) may
be supplemented with endorectal-coil imaging per institutional norms.

DISEASE CHARACTERISTICS:

- Diagnosis of prostate adenocarcinoma by transrectal ultrasound (TRUS)-guided biopsy
between 28 to 90 days prior to enrollment

- Minimal tumor burden as defined by at least one of the following criteria:

- One single core with ≥ 50% cancer burden and ≥ 5 mm tumor length

- Two or more cores in the same prostate region, each with ≥ 30% cancer burden

- Three or more cores positive for prostate cancer (of any magnitude of cancer
burden) in the same prostate region

- Gleason score of 7 or higher cancer burden

- Prostate-specific antigen (PSA) ≥ 10 ng/mL

PATIENT CHARACTERISTICS:

- Able to tolerate magnetic resonance imaging (MRI) required by protocol, to be
performed at an American College of Radiology Imaging Network (ACRIN)-qualified
facility and scanner

- Not suitable to undergo MRI or gadolinium-based contrast agent because of:

- Severe claustrophobia not relieved by oral anxiolytics per institutional standard
practice

- Presence of MRI-incompatible metallic objects or implanted medical devices in
body (including, but not limited to, non-MRI compatible metal objects, cardiac
pacemaker, aneurysm clips, artificial heart valves with steel parts, or metal
fragments in the eye or central nervous system)

- Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min
based on a serum creatinine level obtained within 48 hours prior to enrollment

- Weight greater than that allowable by the MRI table, per local institutional
practice

PRIOR CONCURRENT THERAPY:

- No anti-androgenic therapy within 30 days prior to enrollment

- No prior external-beam radiotherapy, proton radiotherapy, or brachytherapy to the
prostate

- No prior hip replacement or other major pelvic surgery