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

Not Applicable

Completed

• Conditions: Positron-Emission Tomography; Fluorocholine; Prostatic Neoplasm
• Interventions: Device: mpMRI; Device: PET Scan ou TEP-TDM

• Registration Number: NCT02971995
• Lead Sponsor: Lille Catholic University

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-06
• Primary Completion: 2016-03
• Study Completion: 2016-10
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostate cancer/mpMRI	mpMRI	-
Prostate cancer/TEP scan	PET Scan ou TEP-TDM	-

Primary Outcome Measures

Name	Time	Method
Number of image guided prostate biopsy in the zones detected by the TEP scan	at inclusion

Secondary Outcome Measures

Name	Time	Method
Number of image guided prostate biopsy in the zones detected by the mpMRI	at inclusion