Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer (DEMETER)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
imaging in trimodality
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer focused on measuring prostate cancer, Imaging, trimodality
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- second cancer
- contraindication to MRI
- participation in an another therapeutic trial
- patients under guardianship or curatorship
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trimodality
Arm Description
PET-CT with fluorocholine and MRI
Outcomes
Primary Outcome Measures
Delineation volumes
Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique
Secondary Outcome Measures
Treatment plan
percentage of patient for whom the therapeutic decision will be different with standard assessment
Dosimetry
Variation of dosimetry between trimodality imaging and standard assessment
F-choline fixation in MRI
Comparison of percentage of choline fixation during magnetic resonance imaging
contouring of target lesions and organ at risk
comparison of contouring duration with the two techniques of imagery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03734757
Brief Title
Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer
Acronym
DEMETER
Official Title
Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
October 16, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Prostate cancer (Pca) is the first human cancer in terms of incidence and the third leading cause of tumor death (56,000 new cases/year in France in 2012 and nearly 9,000 deaths). According to the French Association of Urology 2013, an individual screening based on rectal examination and prostatic specific antigen (PSA) is recommended for men over 50. Ultrasound (US) guided biopsy allows the histological diagnosis and the Gleason score evaluation. For high-risk of prostate Cancer, initial staging is based on pelvic Magnetic Resonance Imaging, abdominal pelvic computed tomography and bone scan.
External radiotherapy combined with prolonged hormone therapy is the reference treatment for these cancers.
Radiotherapy requires a planning Computed Tomography. Magnetic Resonance Imaging is known to be better for definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult for the radiotherapy planning.
Moreover, Positron Emission Tomography-Computed Tomography with Fluorocholine detects earlier nodal and bone metastasis.
Hypothesis: A single planning acquisition in trimodality in radiotherapy position should improve simultaneously the initial staging and the volume delineation for radiotherapy.
Main objective: Main objective is to compare volumes delineation (prostatic target and organ at risk) thanks to geometric index (Jaccard, Dice and overlap), got by trimodality and by standard initial staging and planning Computed Tomography.
Expected results: Thanks to literature data, it can be expected that prostatic delineation target volume will significantly decrease with Magnetic Resonance Imaging.
Furthermore, thanks to Positron Emission Tomography-Computed Tomography with Fluorocholine, radiotherapy planning would be different, detecting 14% of nodal extension and 7% of bone metastasis.
Finally, with trimodality the investigators expect a smaller prostate volume and a higher detection of metastatic lymph node or bone metastasis.
Then, the investigators expect an improvement of the management of patients by:
Detecting more nodal or bone metastasis and avoiding a useless local treatment by radiotherapy
Improving prostatic target volume delineation and allowing a better protection of organ at risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, Imaging, trimodality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trimodality
Arm Type
Experimental
Arm Description
PET-CT with fluorocholine and MRI
Intervention Type
Procedure
Intervention Name(s)
imaging in trimodality
Intervention Description
PET-CT and MRI
Primary Outcome Measure Information:
Title
Delineation volumes
Description
Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Treatment plan
Description
percentage of patient for whom the therapeutic decision will be different with standard assessment
Time Frame
6 weeks
Title
Dosimetry
Description
Variation of dosimetry between trimodality imaging and standard assessment
Time Frame
6 weeks
Title
F-choline fixation in MRI
Description
Comparison of percentage of choline fixation during magnetic resonance imaging
Time Frame
1 day
Title
contouring of target lesions and organ at risk
Description
comparison of contouring duration with the two techniques of imagery
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
second cancer
contraindication to MRI
participation in an another therapeutic trial
patients under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Charlotte Bouyeure, MD
Phone
+33232083030
Email
anne-charlotte.bouyeure@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Charlotte Bouyeure, MD
Phone
+33232083030
Email
anne-charlotte.bouyeure@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer
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