An observational study in Prostate Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 112 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Prostate cancer
Exclusion Criteria:
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
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.
Time frame: within 6 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris