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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
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    November 16, 2016
    Last Updated
    November 21, 2016
    Sponsor
    Lille Catholic University
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    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

    Learn more about this trial

    Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies

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