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Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants With High-Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03085043
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Procedure: Bone Scan Procedure: Computed Tomography Procedure: Magnetic Resonance Imaging Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
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 30, 2025
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.
Procedure: Bone Scan
Undergo bone scan

Procedure: Computed Tomography
Undergo CT of the abdomen and pelvis
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Procedure: Magnetic Resonance Imaging
Undergo pelvic MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging
Undergo magnetic resonance whole body diffusion-weighted imaging
Other Names:
  • WB DW MRI
  • WB-DWI
  • Whole Body Magnetic Resonance Imaging Using Diffusion-Weighted Images
  • Whole-Body Diffusion-Weighted MRI




Primary Outcome Measures :
  1. Accuracy of whole body magnetic resonance imaging (MRI) [ Time Frame: 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 Outcome Measures :
  1. Sensitivity of MRI, bone scan, and CT scan [ Time Frame: 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.

  2. Specificity of MRI, bone scan, and CT scan [ Time Frame: 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.

  3. Positive predictive value (PPV) of MRI, bone scan, and CT scan [ Time Frame: 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.

  4. Negative predictive value (NPV) of MRI, bone scan, and CT scan [ Time Frame: 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.

  5. Detection of other types of metastases [ Time Frame: Up to 9 years ]
    Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate.



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

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).

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, MBBS,MD 713-792-2533 TKBathala@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tharakeswara K. Bathala    713-792-2533      
Principal Investigator: Tharakeswara K. Bathala         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tharakeswara K Bathala 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
NCI-2018-01308 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0053 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases