NCT01501630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

December 26, 2011

Last Update Submit

October 13, 2015

Conditions

Prostate Cancer

Keywords

Comparison of imaging modalitiesImpact on patient managementOptimisation of cost of the diagnostic strategy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PET/CT and MRI

all patients will benefit from PET/CT and MRI

Device: performance of PET/CT and whole-body MRI

Interventions

performance of PET/CT and whole-body MRIDEVICE

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

PET/CT and MRI

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Médecine Nucléaire - Hôpital TENON

Paris, 75020, France

Location

Related Publications (1)

  • 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.

    PMID: 32122345DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jean-Noël TALBOT, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2011

First Posted

December 29, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

FR(1)