Text Size

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

This study is currently recruiting participants.
Verified September 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01501630
First received: December 26, 2011
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Device: performance of PET/CT and whole-body MRI

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • bone metastases [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PET/CT and MRI
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prostate cancer

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501630

Contacts
Contact: Jean-Noël TALBOT, MD,PhD 33 1 56 01 67 98 Jean-noel.talbot@tnn.aphp.fr

Locations
France
Service Médecine Nucléaire - Hôpital TENON Recruiting
Paris, France, 75020
Contact: Jean-Noël TALBOT, MD,PhD         Jean-noel.talbot@tnn.aphp.fr    
Principal Investigator: Jean-Noël TALBOT, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Noël TALBOT, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01501630     History of Changes
Other Study ID Numbers: P090105, 2011-A01041-40
Study First Received: December 26, 2011
Last Updated: September 6, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Comparison of imaging modalities
Impact on patient management
Optimisation of cost of the diagnostic strategy

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013