Prostate Cancer Clinical Trial
— DEMETEROfficial title:
Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 16, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Henri Becquerel | Rouen |
Lead Sponsor | Collaborator |
---|---|
Centre Henri Becquerel |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delineation volumes | Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique | 1 day | |
Secondary | Treatment plan | percentage of patient for whom the therapeutic decision will be different with standard assessment | 6 weeks | |
Secondary | Dosimetry | Variation of dosimetry between trimodality imaging and standard assessment | 6 weeks | |
Secondary | F-choline fixation in MRI | Comparison of percentage of choline fixation during magnetic resonance imaging | 1 day | |
Secondary | contouring of target lesions and organ at risk | comparison of contouring duration with the two techniques of imagery | 6 weeks |
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