Firmagon
Drug120 mg subcutaneous Injection of Firmagon after a TEP-PSMA
Other names: Injection of Firmagon after a TEP-PSMA
NCT Number: NCT04391556
Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment
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Notify Me18 year and older
Male
Interventional
Phase 2
Centre Jean Perrin, Clermont-Ferrand, France
The identification of lesions responsible for biological recurrence or persistent biological disease in patients with prostatic adenocarcinoma (PA) remains an outstanding problem due to the lack of sensitivity of standard imaging techniques. The efficacy of empirical radiation therapy of the prostate + pelvis zone in only half of patients with increased PSA suggests an underestimation of lesions.
PET-68Ga-PSMA or PET-PSMA technique showed a clear gain in sensitivity for the detection of lesions in this context compared to PET-Choline which was already more sensitive than standard imaging. It is about 50% for a PSA <0.5 ng / ml vs 20% for a PSA <1 ng / ml for TEP-Choline technique. However, the indication of empirical radiotherapy is raised when the PSA exceeds 0.2 ng / ml. It is therefore still necessary to increase the sensitivity of PET-PSMA.
A flare-up-related effect was observed in a small animal experiment and in a patient after androgen blocking treatment, inducing a sharp increase in the intensity of previously visualized lesions and the appearance of 13 new lesions.
It would therefore be possible to increase the expression of PSMA by the lesions at the origin of the biological recurrence of AP and thus to improve their detection by PET-PSMA after potentiation by short-term androgen blocking by an antagonist of LH-RH.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
120 mg subcutaneous Injection of Firmagon after a TEP-PSMA
Other names: Injection of Firmagon after a TEP-PSMA
Time frame: Day 14 after the androgenic blockade
PSMA-PET
Time frame: Day 14 after the androgenic blockade
PSMA-PET and PSMA-H-PET
Time frame: Day 14 after the androgenic blockade
Number of lesions (PSMA-ET and PSMA-H PET)
Time frame: Day 14 after the androgenic blockade
Fixation intensity (PSMA-ET and PSMA-H PET)
Time frame: Day 14 after the androgenic blockade
Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET
Time frame: Day 14 after the androgenic blockade
PSMA-PET and PSMA-H-PET efficience
Time frame: Day 14 after the androgenic blockade
PSMA-PET efficience
Time frame: Day 14 after the androgenic blockade
PSA rate
Time frame: Day 14 after the androgenic blockade
PSA and testosterone rates and PSMA-PET results
Time frame: Up to Day 15-30 visit
Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Time frame: Day 14 after the androgenic blockade
PET-PSMA and PET-PSMA-H
Centre Leon Berard
Other
Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment
Acronym: PREFAcE
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