Clinical trial · Interventional
Early Assessment of Treatment Response Using Functional Diffusion Mapping
NCT02064283CI-TRIAL-00016300completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diffusion MRI Assessment
- description
- Men with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks.
- interventionNames
- Procedure: Diffusion MRI
Primary outcomes (1)
- measure
- Change in diffusion MRI measurements
- timeFrame
- Baseline, 2 weeks and 9-12 weeks
- description
- Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.
Secondary outcomes (2)
- measure
- Change in units/L of CK18Asp306
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate cancer. * Evidence of metastatic disease by bone scan. * Patients must be initiating systemic therapy for metastatic disease. * New D2 disease beginning therapy with androgen deprivation. * CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy. * Patients must be willing to provide the blood samples for the correlative markers. * Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes. * Life expectancy of 12 weeks or greater. * All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Contraindication to MRI imaging. * Patients who require sedation with general anesthesia to undergo MRI imaging. * Weight greater than 275 pounds.
References
Publications (1)
- DERIVEDBrisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015. PMID 25859981