Clinical trial NCT01562223: Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer
Official title: Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate cancer or any cancer that remains after biopsy.

PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate cancer.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
timeFrame: 2 to 14 Days
Secondary outcomes:
measure: Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor
timeFrame: 2 to 14 Days
measure: Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans
timeFrame: 2 to 14 Days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Mark A. Rosen
role: PRINCIPAL_INVESTIGATOR
References: