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

Prostate Cancer Clinical Trial

— TEPCholine  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03201380
• Other study ID #: TEP Choline-IPC 2016-007
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2017
• Last updated: June 27, 2017
• Start date: November 1, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2017
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 1, 2017
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have had a TEP scan in the choline

• Prostate cancer

Exclusion Criteria:

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• TEP scanner with choline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Modifications of therapeutic strategy in the care of prostate cancers	Disease evaluation method by scanner with choline	One year

External Links

•   Institut PAOLI-CALMETTES