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Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer

Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03734757
Acronym
DEMETER
Enrollment
20
Registered
2018-11-08
Start date
2019-02-14
Completion date
2020-12-10
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, Imaging, trimodality

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.

Interventions

PROCEDUREimaging in trimodality

PET-CT and MRI

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Delineation volumes1 dayMeasure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique

Secondary

MeasureTime frameDescription
Treatment plan6 weekspercentage of patient for whom the therapeutic decision will be different with standard assessment
Dosimetry6 weeksVariation of dosimetry between trimodality imaging and standard assessment
F-choline fixation in MRI1 dayComparison of percentage of choline fixation during magnetic resonance imaging
contouring of target lesions and organ at risk6 weekscomparison of contouring duration with the two techniques of imagery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026