RT Journal Article
SR Electronic
T1 Survey by the French Medicine Agency (ANSM) of the practice, result and impact of 1177 PSMA-11 PET/CT examinations in the biochemical recurrence of prostate cancer
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 1257
OP 1257
VO 61
IS supplement 1
A1 Yanna-Marina CHEVALME
YR 2020
UL http://jnm.snmjournals.org/content/61/supplement_1/1257.abstract
AB 1257Introduction: The Heidelberg team reported in 2015 that PET/CT with PSMA-11, a 68Ga-labeled ligand of the prostate-specific membrane antigen, can detect prostate cancer (PC) tissue. In France, it formed the rationale to submit nominative requests (ATU) prospectively to ANSM for performing PSMA-11 PET/CT in case of biochemical recurrence (BCR) of PC. To comply with this procedure, 18F-fluorocholine (FCH) must be negative or equivocal or discrepant with other imaging modalities. In the ATU agreement, it was specified that the applicants must deliver information to ANSM about the tolerance and efficacy of this diagnostic agent in each patient. All information obtained during the first 3 years of issuing ATUs was gathered, checked and analysed by ANSM. Patients, material and methods : Between May 2016 and April 2019, 1177 ATUs were followed by PSMA-11 PET/CT, in 6 PET/CT centres. Patients’ age: mean 69.3 years (median 69.8 range 42-89). The source of PSMA-11 was Iason (Austria) for all centres; the 68Ge/68Ga generator was either Galliapharm or GalliAd. The manufacturer of PET/CT machines were Siemens (54% of PET/CTs), Philips (26%), or GE (20%). Results: Injected activity of PSMA-11 per kg of body mass: mean 1.8 MBq / kg (median 1.9 range 0.5-3.6). CT contrast medium: none 74%, IV 19%, oral 7%. CT dose length product: mean 624 mGy.cm (609, 209-2786). Number of image acquisitions per exam: 1 = 23%, 2 = 73%, 3 = 4%. No difference in positivity rate was found according to 1) whether a contrast medium was administered or not 2) the number of image acquisitions per exam. Positivity rate and impact on diagnostic thinking of PSMA-11 PET/CT varied significantly according to the PSA serum level at PET/CT, the Gleason score and the initial curative therapy, as reported in the table.View this table: Conclusion: PET/CT with PSMA-11 can detect PC tissue in case of BCR whereas FCH is non conclusive. In this large series we confirm that this is true at low PSA serum level <1ng/mL but also at higher levels >2 despite non conclusive FCH. Therefore the current imaging practice for BCR in France could be reverted in the near future: PSMA-11 as 1st line and then FCH in cases of PC which does not overexpress PSMA.