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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

StatusActive, Not Recruiting
PhaseNot applicable
Started2016-04-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Apr 30, 2026 → Apr 30, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Amendment history

2026-09-25
Primary completion pushed: 2026-04-30 → 2028-04-30
Completion pushed: 2026-04-30 → 2028-04-30
2026-03-03
Study Status v13
Re-verified, no change to tracked fields
2025-09-03
Study Status v12
Primary completion date2025-04-30→2026-04-30
2025-03-25
Study Identification, Study Status v11
Study titlerevised
Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants withWith High-Risk Prostate Cancer
2024-09-06
Study Identification, Study Status v10
Study titlerevised
Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants Withwith High-Risk Prostate Cancer
Show 9 earlier versions
2024-03-07
Study Status v9
Re-verified, no change to tracked fields
2023-09-01
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 86→confirmed 98
Study sitesdetails revised at 1 of 1 site
2020-08-04
Study Status v7
Re-verified, no change to tracked fields
2019-07-11
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2025-04→2025-04-30
Completion date2026-04→2026-04-30
InterventionsBone Scan (Procedure), Computed Tomography (CT) (Procedure), Standard of Care Pelvic MRI (Procedure), Whole Body Magnetic Resonance Imaging…→Bone Scan (Procedure), Computed Tomography (Procedure), Magnetic Resonance Imaging (Procedure), Magnetic Resonance Whole Body…
Eligibility criteria+8 characters
Inclusion Criteria: Prostate carcinoma patients at high risk for metastasis with Prostateprostate-Specificspecific Antigenantigen (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 Testosteronetestosterone suppressing medication (i.e., Lupronlupron, Degarelixdegarelix, Abirateroneabiraterone, enzalutamide) or local radiation therapy. Contraindication to Magneticmagnetic Resonanceresonance Ima [...] [...]
Secondary endpoints+250 characters
Sensitivity of MRI, bone scan, and CT scan Specificity of MRI, bone scan, and CT scan Positive predictive value (PPV) of MRI, bone scan, and CT scan Negative predictive value (NPV) of MRI, bone scan, and CT scan Detection of other types of metastases
Primary endpoints1 entry, revised
Accuracy of Bodywhole body magnetic resonance imaging (MRI and Bone Scan plus CT in Detecting Metastasis in High Risk Prostate Cancer Participants)
Study description-478 characters
IfPRIMARY youOBJECTIVES: I. agree,To youcompare willaccuracies have aof whole body MRImagnetic along with your standard-of-care MRI of the pelvis. Adding the whole-body MRIresonance imaging to(MRI) 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-careversus bone scan and aplus computed tomography (CT) scan ofin yourdetecting abdomenbone andor pelvislymph node metastasis in high risk prostate cancer patients. ResearchersOUTLINE: Participants willundergo com [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+35 characters
Magnetic Resonance Whole Body Diffusion-Weighted Imaging asin aFinding ComprehensiveBone Stagingor ToolLymph forNode theMetastasis Evaluationin ofParticipants With High-Risk Prostate CarcinomaCancer
2019-05-23
2 amendments v4-v5
2 re-verifications since 2019-05-08, no change to tracked fields
2018-04-19
Study Status v3
Completion date2025-04→2026-04
2017-11-27
Study Status, Study Description v2
Study description-336 characters
[...] can, and whole body MRI scans are complete at initial visit. 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 [...]
2017-06-02
Study Status, Study Description v1
Study description-174 characters
If participantyou agreesagree, participantyou will have a whole body MRI along with participant'syour standard-of-care MRI of the pelvis. Adding the whole-body MRI imaging to participant'syour pelvic MRI will add about 20-30 minutes to the current stan [...] he total amount of time for the MRIs will be 60-70 minutes. ParticipantYou will also have participant'syour standard-of-care bone scan and a computed tomography (CT) scan of participant'syour abdomen and pelvis. Researchers will compare the results of these procedures to participant'syour whole-body MRI. Length of Study Participation: All of the [...] [...]
2017-03-15
Original filing
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.
Trial Details
NCT Number NCT03085043
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Prostate Carcinoma
Enrollment 98 participants
Start Date 2016-04-20
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24