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

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ClinicalTrials.gov Identifier: NCT03085043
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Whole Body Magnetic Resonance Imaging (MRI) Procedure: Standard of Care Pelvic MRI Procedure: Bone Scan Procedure: Computed Tomography (CT) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma
Actual Study Start Date : April 20, 2016
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Whole-Body MRI Imaging

Participant has a whole body MRI along with standard-of-care MRI of the pelvis.

Participant also has standard-of-care bone scan and a computed tomography (CT) scan of abdomen and pelvis.

Scans performed at baseline and at 6 months.

Procedure: Whole Body Magnetic Resonance Imaging (MRI)
Whole body MRI with diffusion-weighted imaging performed at baseline and in 6 months.

Procedure: Standard of Care Pelvic MRI
Standard of care pelvic endorectal coil MRI performed at baseline and in 6 months.

Procedure: Bone Scan
Standard of care bone scan performed at baseline and in 6 months.

Procedure: Computed Tomography (CT)
CT abdomen and pelvis performed at baseline and in 6 months.




Primary Outcome Measures :
  1. Accuracy of Body MRI and Bone Scan plus CT in Detecting Metastasis in High Risk Prostate Cancer Participants [ Time Frame: 6 months ]
    Comparison between MRI and bone scan carried out using McNemar's test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085043


Contacts
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Contact: Tharakeswara K. Bathala, MD, MBBS 713-792-2533

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Tharakeswara K. Bathala, MD, MBBS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03085043     History of Changes
Other Study ID Numbers: 2015-0053
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Whole body MRI
MRI of the pelvis
Magnetic resonance imaging
Bone scan
Computed tomography scan of abdomen and pelvis
CT

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases