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Therefore, patients with biochemical recurrence (BCR) of prostate cancer frequently undergo FCH as the 1st-line PET\/CT. Actually, the positivity rate (PR) of a second-line PSMA-11 PET\/CT in case of negative FCH PET\/CT has only been reported in few short series, in a total of 185 patients. Our aims were to check (1) whether the excellent PR reported with PSMA-11 is also obtained in BCR patients whose recent FCH PET\/CT was negative or equivocal; (2) in which biochemical and clinical context a high PSMA-11 PET\/CT PR may be expected in those patients, in particular revealing an oligometastatic pattern; (3) whether among the various imaging protocols for PSMA-11 PET\/CT used in France, one yields a significantly highest PR; (4) the tolerance of PSMA-11.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Patients and methods<\/jats:title>\n                <jats:p>Six centres performed <jats:sup>68<\/jats:sup>Ga-PSMA-11 PET\/CTs during the first 3 years of its use in France. Prior to each PET\/CT, the patient\u2019s data were submitted prospectively for authorisation to ANSM, the French Medicine Agency. The on-site readings of 1084 PSMA-11 PET\/CTs in BCR patients whose recent FCH PET\/CTs resulted negative or equivocal were pooled and analysed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>(1) The overall PR was 68%; for a median serum PSA level (sPSA) of 1.7 ng\/mL, an oligometastatic pattern (1\u20133 foci) was observed in 31% of the cases overall; (2) PR was significantly related to sPSA (from 41% if &lt; 0.2 ng\/mL to 81% if \u2265 2 ng\/mL), to patients\u2019 age, to initial therapy (64% if prostatectomy vs. 85% without prostatectomy due to frequent foci in the prostate fossa), to whether FCH PET\/CT was negative or equivocal (PR = 62% vs. 82%), and to previous BCR (PR = 63% for 1st BCR vs. 72% in case of previous BCR); (3) no significant difference in PR was found according to the imaging protocol: injected activity, administration of a contrast agent and\/or of furosemide, dose length product, one single or multiple time points of image acquisition; (4) no adverse event was reported after PSMA-11 injection, even associated with a contrast agent and\/or furosemide.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Compared with the performance of PSMA-11 PET\/CT in BCR reported independently of FCH PET\/CT in 6 large published series (<jats:italic>n<\/jats:italic> &gt; 200), the selection based on FCH PET\/CT resulted in no difference of PSMA-11 PR for sPSA &lt; 1 ng\/mL but in a slightly lower PR for sPSA \u2265 1 ng\/mL, probably because FCH performs rather well at this sPSA and very occult BCR was over-represented in our cohort. An oligometastatic pattern paving the way to targeted therapy was observed in one fourth to one third of the cases, according to the clinico-biochemical context of the BCR. Systematic dual or triple acquisition time points or administration of a contrast agent and\/or furosemide did not bring a significant added value for PSMA-11 PET\/CT positivity and should be decided on individual bases.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00259-020-05086-1","type":"journal-article","created":{"date-parts":[[2021,1,8]],"date-time":"2021-01-08T10:03:13Z","timestamp":1610100193000},"page":"2935-2950","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Survey by the French Medicine Agency (ANSM) of the imaging protocol, detection rate, and safety of 68Ga-PSMA-11 PET\/CT in the biochemical recurrence of prostate cancer in case of negative or equivocal 18F-fluorocholine PET\/CT: 1084 examinations"],"prefix":"10.1007","volume":"48","author":[{"given":"Yanna-Marina","family":"Chevalme","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lotfi","family":"Boudali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Gauth\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Rousseau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Skanjeti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Merlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Robin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Laure","family":"Giraudet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Janier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-No\u00ebl","family":"Talbot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,8]]},"reference":[{"key":"5086_CR1","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1007\/s00259-013-2525-5","volume":"41","author":"A Afshar-Oromieh","year":"2014","unstructured":"Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, et al. 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As this study implies no intervention on the patient, the Regulatory Department of ANSM (the French national Medicine Agency) stated, according to Article 3 of the French \u201cCode de la Sant\u00e9 Publique\u201d (R.1121-1), that it is performed according to ethics, without necessity to refer to any other Ethics Committee.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Yes. Patients consented that their data collected for the PSMA-11 PET\/CT will be analysed and published anonymously.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Same as above","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Excel","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}