NCT03734757

Brief Summary

The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS). For this type of cancer, reference treatment is radiotherapy combined with hormone therapy. The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography. The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension. It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging. Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy. The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison). In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable prostate-cancer

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

First Submitted

Initial submission to the registry

October 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

October 31, 2018

Last Update Submit

December 29, 2025

Conditions

Prostate Cancer

Keywords

prostate cancerImagingtrimodality

Outcome Measures

Primary Outcomes (1)

  • Delineation volumes

    Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique

    1 day

Secondary Outcomes (4)

  • Treatment plan

    6 weeks

  • Dosimetry

    6 weeks

  • F-choline fixation in MRI

    1 day

  • contouring of target lesions and organ at risk

    6 weeks

Study Arms (1)

Trimodality

EXPERIMENTAL

PET-CT with fluorocholine and MRI

Procedure: imaging in trimodality

Interventions

imaging in trimodalityPROCEDURE

PET-CT and MRI

Trimodality

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18 years
  • prostate cancer : High risk (according to D'Amico Classification)
  • and/or Node positive on MRI
  • T2c-T3 on MRI
  • with staging assessment
  • will receive radiotherapy

You may not qualify if:

  • second cancer
  • contraindication to MRI
  • participation in an another therapeutic trial
  • patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 8, 2018

Study Start

February 14, 2019

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)