Skip to main content
OpenTrials
Completed

NCT Number: NCT01501630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Service Médecine Nucléaire - Hôpital TENON

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

performance of PET/CT and whole-body MRI

Device

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

Primary outcomes

  1. bone metastases

    Time frame: within 6 months

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: FLUPROSTIC

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 29, 2011
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.