Evaluation of the Practice of the TEP Choline at Patients With Prostate Cancer (TEPCholine)

Evaluation of the Practice of the TEP Choline in Provence - Alps and Côte d'Azur at Patients With Prostate Cancer - Multicentre Retrospective Study.

The prostate cancer is a heterogeneous disease the care of which varies according to the status: localized, locally advanced, or in recurrence after local or metastatic treatment. The precise evaluation of the degree of extension of the disease is thus essential because it is going to allow to adapt at best the therapeutic strategy.

Contrary to the abdomino-pelvic scanning and to the osseous scintigraphy which(who) are a member(part) of the balance assessment of standard extension of the prostate cancer, the place of the Tomography with broadcast of Positrons to scan (TEP scan) in Choline in the management of patients affected by prostate cancer is not clearly defined in the national and European recommendations.

The current marketing authorization ( AMM) is the research for bones localizations in the prostatic cancers at high risk. It indeed seems that this examination is more successful than the standard radiological examinations (bone scintigraphy and abdomino-pelvic scanning) in the detection of the bone metastatic hurts, with a sensibility of about 100 % and a precision of the order of 93 % according to certain studies.

The recent data of the literature suggest a quite particular interest at the patients in situation of biochemical recurrence in terms of localization of (or) tumoral site (s).

THE AMM however not specifying if this examination has to be made within the framework of the initial balance sheet of extension, at the time of the biochemical second offense or at the known metastatic stage, there is a big variability of the practices according to the centers.

The current indications being very ill-assorted, he is interesting being able to estimate the heterogeneousness of the practices of way multicentre, by leading a study observationally retrospective in region Provence-Alpes-Côte d'Azur (PACA).

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: TEP scanner with choline

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients having had a TEP in the choline for a prostate cancer

Description

Inclusion Criteria:

• Have had a TEP scan in the choline
• Prostate cancer

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEP scan in Choline indications in the care of prostate cancers and more particularly the search for bone metastasis at diagnosis	Disease evaluation method by scanner with choline	One year
Number of TEP scan in Choline indications in the care of prostate cancers and more particularly the search for bone metastasis at the site of relapse after local treatment	Disease evaluation method by scanner with choline	One year
Number of TEP scan in Choline indications of TEP scan in Choline in the care of prostate cancers and more particularly the search for bone metastasis during the follow-up of the disease	Disease evaluation method by scanner with choline	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifications of therapeutic strategy in the care of prostate cancers	Disease evaluation method by scanner with choline	One year

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: PIGNOT Géraldine, MD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• Institut PAOLI-CALMETTES

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (ACTUAL): June 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: TEP Choline-IPC 2016-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No