A Phase 2/3 interventional study of F-Choline-PET in Castration-resistant Prostate Cancer, sponsored by University Hospital, Grenoble. Terminated at 3 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-28.
Sponsored by University Hospital, Grenoble · Phase 2/3, Interventional, and Diagnostic
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.
University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
The F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide.
Device: F-Choline-PET
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.
Time frame: 12 weeks
Study of global survival and progression-free survival according to the results of baseline F-choline PET .
Time frame: 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.
Time frame: 12 weeks
Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values.
Time frame: 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.
Time frame: 24 weeks
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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