Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:April 20, 2016
End Date:April 2026
Contact:Tharakeswara K. Bathala, MD, MBBS
Phone:713-792-2533

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The goal of this clinical research study is to compare 2 different types of magnetic
resonance imaging (MRI). Researchers will compare diffusion-weighted imaging (a method to
show how water moves in a certain area) with standard-of-care imaging to learn which method
is better to check the status of prostate cancer.

This is an investigational study. The whole-body MRI scan in this study is performed using an
FDA-approved and commercially available method. Having whole- body MRI with your
standard-of-care MRI of the pelvis at the same time is investigational.

Up to 86 participants will be enrolled in this study. All will take part at MD Anderson.

If you agree, you will have a whole body MRI along with your standard-of-care MRI of the
pelvis.

Adding the whole-body MRI imaging to your pelvic MRI will add about 20-30 minutes to the
current standard-of-care MRI procedure. The total amount of time for the MRIs will be 60-70
minutes.

You will also have your standard-of-care bone scan and a computed tomography (CT) scan of
your abdomen and pelvis. Researchers will compare the results of these procedures to your
whole-body MRI.

Length of Study Participation:

All of the scans described above will be scheduled and completed within 90 days of signing
this consent or before beginning any treatment. If you cannot complete the scans within 90
days or before beginning treatment, you will not be able to continue to take part in the
study. Your active study participation will be over when the bone scan, CT scan, and whole
body MRI scans are complete at initial visit.

Inclusion Criteria:

1. Prostate carcinoma patients at high risk for metastasis with Prostate-Specific Antigen
(PSA) more than 20 ng/ml and/or Gleason score =8/ >8

2. Ability to understand and sign informed consent

Exclusion Criteria:

1. Patient is at low risk for metastasis with Gleason score at diagnosis <8

2. Currently receiving or history of systemic therapy with Testosterone suppressing
medication (i.e., Lupron, Degarelix, Abiraterone, enzalutamide) or local radiation
therapy

3. Contraindication to Magnetic Resonance Imaging (MRI)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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