Clinical trial NCT01501630: Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Comparison of imaging modalities
Impact on patient management
Optimisation of cost of the diagnostic strategy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 112
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Histologically proven prostate cancer.
* Abnormal plasmatic level of prostate specific antigen dating less than 3 months, initial Gleason score available
* Written informed consent.

Exclusion Criteria:

* Other active cancer or bone infection.
* Chemotherapy or change in hormone therapy since the last PSA assay
* Contraindication to MRI without contrast agent (claustrophobia, pace maker, metallic foreign body, some cardiac valves). Metallic joint prostheses are NOT a contraindication.
* Allergic reaction to radiopharmaceuticals that will be used.
* Patient who seems not capable of staying in the gantry of the machines during the examinations without moving.

Primary outcomes:
measure: bone metastases
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service Médecine Nucléaire - Hôpital TENON
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Noël TALBOT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gauthe M, Zarca K, Aveline C, Lecouvet F, Balogova S, Cussenot O, Talbot JN, Durand-Zaleski I. Comparison of 18F-sodium fluoride PET/CT, 18F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France. BMC Med Imaging. 2020 Mar 2;20(1):25. doi: 10.1186/s12880-020-00425-y.