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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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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.

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

- 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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

bone metastases

Outcome Description:

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.

Outcome Time Frame:

within 6 months

Safety Issue:


Principal Investigator

Jean-Noël TALBOT, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

December 2011

Completion Date:

June 2013

Related Keywords:

  • Prostate Cancer
  • Comparison of imaging modalities
  • Impact on patient management
  • Optimisation of cost of the diagnostic strategy
  • Neoplasm Metastasis
  • Prostatic Neoplasms