Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firmagon | Experimental | 120 mg Firmagon subcutaneous injection after a TEP-PSMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firmagon | Drug | 120 mg subcutaneous Injection of Firmagon after a TEP-PSMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness | PSMA-PET | Day 14 after the androgenic blockade |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation | PSMA-PET and PSMA-H-PET | Day 14 after the androgenic blockade |
| Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET |
| Measure | Description | Time Frame |
|---|---|---|
| In case of envisaged irradiation, impact on the modifications of irradiation volumes between the initial PET-PSMA and the PET-PSMA-H | PET-PSMA and PET-PSMA-H | Day 14 after the androgenic blockade |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure GIRAUDET, MD | Centre Leon Berard | Principal Investigator |
| David KRYZA, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Gabriel Montpied | Clermont-Ferrand | 63003 | France | |||
| Centre Jean Perrin |
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of lesions (PSMA-ET and PSMA-H PET) |
| Day 14 after the androgenic blockade |
| Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET | Fixation intensity (PSMA-ET and PSMA-H PET) | Day 14 after the androgenic blockade |
| Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications | Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET | Day 14 after the androgenic blockade |
| Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection | PSMA-PET and PSMA-H-PET efficience | Day 14 after the androgenic blockade |
| Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening) | PSMA-PET efficience | Day 14 after the androgenic blockade |
| Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening) | PSA rate | Day 14 after the androgenic blockade |
| Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results | PSA and testosterone rates and PSMA-PET results | Day 14 after the androgenic blockade |
| Tolerance profile | Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) | Up to Day 15-30 visit |
| Clermont-Ferrand |
| 63011 |
| France |
| Centre Hospitalier de Grenoble Hôpital Nord Michallon | La Tronche | 38700 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| APHM - Hôpital Nord | Marseille | 13015 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |