NCT03376360

Brief Summary

Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist. Several criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy. Functional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management. Consequently, the objective of this study were:

  • Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer
  • Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

August 15, 2018

Status Verified

November 1, 2017

Enrollment Period

1.6 years

First QC Date

November 24, 2017

Last Update Submit

August 14, 2018

Conditions

Keywords

prostate cancerFcholinepositron emission tomographyMRI

Outcome Measures

Primary Outcomes (1)

  • correlation between Gleason score and dynamic parameters on PET and MRI

    study the potential correlation between dynamic parameters on PET and MRI

    when anatomopathological report is available, an average of 3 months after the PET/CT

Secondary Outcomes (3)

  • reconstructions on 18F-choline PET

    when all 18F-choline PET are performed, an average of 6 months

  • best "fitting" on PET and MRI

    when all MRI are performed, an average of 6 months

  • comparison between data (PSA, TNM stage, EFS and OS)

    01/05/2017

Eligibility Criteria

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

Patients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI

You may qualify if:

  • Patients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI Patient consent

You may not qualify if:

  • No lesion on dynamic acquisition on PET/CT and/or on pelvic MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 18, 2017

Study Start

October 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 15, 2018

Record last verified: 2017-11

Locations