Role of PET/CT With Fluorine-18 Tracers and of Diffusion Weighted Whole-body MRI in the Early Detection of Bone Metastases in Prostate Cancer
In patients with high risk prostate cancer and high PSA levels, PET/CT with fluoride (18F)
and FLUOROCHOLINE (18F) and whole-body MRI will be performed within one month.
Data of a 6 month follow-up after those examination will be made available to a panel of
independent experts. They will determine the standard of truth (SOT) concerning the invasion
of the skeleton and also of soft tissue by prostate cancer tissue, the impact of each
imaging modality on patient management and the adequacy of the decisions. In some cases
(anti-hormone treatment without histology), it will not be possible to determine the SOT.
By comparison of the results of blind readings for each imaging modality with the standard
of truth, the diagnostic performance will be determined.
By simulation, several strategies will be constructed concerning the best examinations to be
performed and the sequence according to the precise clinical circumstances. Their cost and
effectiveness will be evaluated.
Observational
Time Perspective: Prospective
bone metastases
Follow up data (histology, imaging, PSA levels) during 6 months to determine the standard of truth and the adequacy of the management decided on basis of imaging modalities.
within 6 months
No
Jean-Noël TALBOT, MD,PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P090105
NCT01501630
December 2011
June 2013
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