Prostate Cancer
Conditions
Keywords
stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
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.
Interventions
OTHERmotexafin gadolinium
Sponsors
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t) | 2 to 14 Days | The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric \[ ktrans, IAUGC90bn\] using the method of Barnhart and Barboriak, 2009 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor | 2 to 14 Days | The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric using the method of Barnhart and Barboriak, 2009 |
| Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans | 2 to 14 Days | The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric ktrans\] and each method \[ independent and dependent\] using the method of Barnhart and Barboriak, 2009 |
Countries
United States
Outcome results
None listed