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

NCT02971995 | Completed

• 1 other identifier: OBS025
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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) .

Conditions

Prostatic Neoplasm; Positron-Emission Tomography; Fluorocholine

Outcome Measures

Primary Outcomes (1)

• Number of image guided prostate biopsy in the zones detected by the TEP scan

  at inclusion

Secondary Outcomes (1)

• Number of image guided prostate biopsy in the zones detected by the mpMRI

  at inclusion

Study Arms (2)

Prostate cancer/TEP scan

EXPERIMENTAL

Device: PET Scan ou TEP-TDM

Prostate cancer/mpMRI

ACTIVE COMPARATOR

Device: mpMRI

Interventions

PET Scan ou TEP-TDM DEVICE

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

Prostate cancer/TEP scan

mpMRI DEVICE

Performance of the mpMRI in order to determine the place where to take the biopsy

Prostate cancer/mpMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan

Sponsors & Collaborators

• Lille Catholic University: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jean Louis Bonnal, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share