CClinicalTrials.gg
Status unknownNCT03201380TEPCholineUpdated Jun 28, 2017

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

An observational study in Prostate Cancer, sponsored by Institut Paoli-Calmettes. Status unknown. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Institut Paoli-Calmettes · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
Male
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Study 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).

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 300 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not applicable
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • OtherTEP scanner with choline
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What researchers measure

Primary outcomes

  1. 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

    Time frame: One year

  2. 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

    Time frame: One year

  3. 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

    Time frame: One year

Secondary outcomes

  1. Modifications of therapeutic strategy in the care of prostate cancers

    Disease evaluation method by scanner with choline

    Time frame: One year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03201380
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Nov 1, 2014
Primary completion
Nov 1, 2015
Completion
Dec 1, 2017 (estimated)
Last update
Jun 28, 2017

Study contacts

PIGNOT Géraldine, MD
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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