Prostate Carcinoma
Conditions
Brief summary
This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.
Detailed description
PRIMARY OBJECTIVES: I. To compare accuracies of whole body magnetic resonance imaging (MRI) versus bone scan plus computed tomography (CT) scan in detecting bone or lymph node metastasis in high risk prostate cancer patients. OUTLINE: Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body (WB)-diffusion-weighted imaging (DWI) over 20-30 minutes.
Interventions
PROCEDUREBone Scan
Undergo bone scan
PROCEDUREComputed Tomography
Undergo CT of the abdomen and pelvis
PROCEDUREMagnetic Resonance Imaging
Undergo pelvic MRI
PROCEDUREMagnetic Resonance Whole Body Diffusion-Weighted Imaging
Undergo magnetic resonance whole body diffusion-weighted imaging
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ \> 8. * Ability to understand and sign informed consent.
Exclusion criteria
* Patient is at low risk for metastasis with Gleason score at diagnosis \< 8. * Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy. * Contraindication to magnetic resonance imaging (MRI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of whole body magnetic resonance imaging (MRI) | Up to 6 months | Accuracy will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and computed tomography (CT) scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of MRI, bone scan, and CT scan | Up to 9 years | Sensitivity will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
| Specificity of MRI, bone scan, and CT scan | Up to 9 years | Specificity will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
| Positive predictive value (PPV) of MRI, bone scan, and CT scan | Up to 9 years | PPV will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
| Negative predictive value (NPV) of MRI, bone scan, and CT scan | Up to 9 years | NPV will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
| Detection of other types of metastases | Up to 9 years | Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTharakeswara K Bathala
M.D. Anderson Cancer Center
Outcome results
None listed