NCT04391556

Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Firmagon	120 mg subcutaneous Injection of Firmagon after a TEP-PSMA

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-05-02
• Completion: 2024-04-03
• First posted: 2020-05-18
• Last updated: 2025-08-14

Locations

6 sites across 1 country: France