Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer

Prostate Cancer Clinical Trial

— FLUPROSTIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501630
• Other study ID #: P090105
• Secondary ID: 2011-A01041-40
• Status: Completed
• Phase: N/A
• First received: December 26, 2011
• Last updated: October 13, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Service Médecine Nucléaire - Hôpital TENON	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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