Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer (FLUPROSTIC)
Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.Determine the lowest cost strategy according to the precise clinical circumstances.
|Study Design:||Time Perspective: Prospective|
|Official Title:||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|
- bone metastases [ Time Frame: within 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
PET/CT and MRI
all patients will benefit from PET/CT and MRI
Device: performance of PET/CT and whole-body MRI
For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501630
|Contact: Jean-Noël TALBOT, MD,PhD||33 1 56 01 67 98||Jeanfirstname.lastname@example.org|
|Service Médecine Nucléaire - Hôpital TENON||Recruiting|
|Paris, France, 75020|
|Contact: Jean-Noël TALBOT, MD,PhD Jeanemail@example.com|
|Principal Investigator: Jean-Noël TALBOT, MD, PhD|
|Principal Investigator:||Jean-Noël TALBOT, MD,PhD||Assistance Publique - Hôpitaux de Paris|