Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies (PROSTEPIRM)
Primary Purpose
Prostatic Neoplasm, Positron-Emission Tomography, Fluorocholine
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET Scan ou TEP-TDM
mpMRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients with suspicion of prostate cancer
- Patients who performed prostate mpMRI and F-Choline 18 PET scan
- Patient capable of receiving clear informations
- Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
- Patient covered by a healthcare insurance
Exclusion Criteria:
- Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prostate cancer/TEP scan
Prostate cancer/mpMRI
Arm Description
Outcomes
Primary Outcome Measures
Number of image guided prostate biopsy in the zones detected by the TEP scan
Secondary Outcome Measures
Number of image guided prostate biopsy in the zones detected by the mpMRI
Full Information
NCT ID
NCT02971995
First Posted
November 16, 2016
Last Updated
November 21, 2016
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT02971995
Brief Title
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies
Acronym
PROSTEPIRM
Official Title
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).
The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Positron-Emission Tomography, Fluorocholine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate cancer/TEP scan
Arm Type
Experimental
Arm Title
Prostate cancer/mpMRI
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PET Scan ou TEP-TDM
Intervention Description
Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy
Intervention Type
Device
Intervention Name(s)
mpMRI
Intervention Description
Performance of the mpMRI in order to determine the place where to take the biopsy
Primary Outcome Measure Information:
Title
Number of image guided prostate biopsy in the zones detected by the TEP scan
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Number of image guided prostate biopsy in the zones detected by the mpMRI
Time Frame
at inclusion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with suspicion of prostate cancer
Patients who performed prostate mpMRI and F-Choline 18 PET scan
Patient capable of receiving clear informations
Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
Patient covered by a healthcare insurance
Exclusion Criteria:
Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis Bonnal, MD
Organizational Affiliation
GHICL
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies
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