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

Prostatic Neoplasm Clinical Trial

— PROSTEPIRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971995
• Other study ID #: OBS025
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 21, 2016
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: June 2015
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fluorocholine
• Positron-Emission Tomography
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Device:
• PET Scan ou TEP-TDM
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
• mpMRI
Performance of the mpMRI in order to determine the place where to take the biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of image guided prostate biopsy in the zones detected by the TEP scan		at inclusion	Yes
Secondary	Number of image guided prostate biopsy in the zones detected by the mpMRI		at inclusion	Yes