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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: imaging in trimodality

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Charlotte Bouyeure, MD; Phone Number: +33232083030; Email: anne-charlotte.bouyeure@chb.unicancer.fr

Study Locations

• France
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Anne-Charlotte Bouyeure, MD; Phone Number: +33232083030; Email: anne-charlotte.bouyeure@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trimodality; PET-CT with fluorocholine and MRI	Procedure: imaging in trimodality; PET-CT and MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delineation volumes	Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment plan	percentage of patient for whom the therapeutic decision will be different with standard assessment	6 weeks
Dosimetry	Variation of dosimetry between trimodality imaging and standard assessment	6 weeks
F-choline fixation in MRI	Comparison of percentage of choline fixation during magnetic resonance imaging	1 day
contouring of target lesions and organ at risk	comparison of contouring duration with the two techniques of imagery	6 weeks

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): October 16, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Imaging; prostate cancer; trimodality
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CHB18.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No