Evaluation of the Practice of the TEP Choline at Patients With Prostate Cancer

• Conditions: Prostate Cancer

• Registration Number: NCT03201380
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-11-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28
• Study Completion: 2017-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of TEP scan in Choline indications in the care of prostate cancers and more particularly the search for bone metastasis at diagnosis	One year	Disease evaluation method by scanner with choline
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	One year	Disease evaluation method by scanner with choline
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	One year	Disease evaluation method by scanner with choline

Secondary Outcome Measures

Name	Time	Method
Modifications of therapeutic strategy in the care of prostate cancers	One year	Disease evaluation method by scanner with choline