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Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. To know soon that the treatment is effective will be decisive for the oncologist, even more in palliative situation where second effects can't be imposed to patients.
In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new therapy. Moreover, the investigators suppose that we can assess an early stage if there is an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and expansive treatment.
The aim of this study is to assess if it is possible to determine early (6 weeks of treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or enzalutamide in post-docetaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-Choline PET | Experimental | The F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-Choline-PET | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide | A centralized review will be carried out by 2 independent reviewers. The gold-standard to evaluate tumoral response to abiraterone acetate or enzalutamide will be the pain, the Prostate Specific Antigen rate, and imagery at 3 months according to prostate cancer working group. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study of global survival and progression-free survival according to the results of baseline F-choline PET . | 24 weeks | |
| Study of global survival and progression-free survival at 12 weeks of treatment according to the results of 6 weeks treatment F-choline PET. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Vuillez, MD PHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble | Grenoble | 38 000 | France | |||
| Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 12 weeks |
| Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values. | 12 and 24 weeks |
| Study of global survival and progression-free survival at 24 weeks of treatment according to the results of 6 weeks treatment F-choline PET. | 24 weeks |
| Grenoble |
| 38 000 |
| France |
| Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste | Grenoble | 38 000 | France |
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