P. Caroli1, U. De Giorgi2, L. Fantini1, R. Galassi4, A. Moretti4, G. Gualtieri1, E. Scarpi3, D. Amadori2, G. Paganelli1 and F.

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1 A pilot study for early treatment evaluation with 18F-Methilcholine PET/CT in metastatic castration-resistant prostate cancer patients treated with enzalutamide P. Caroli1, U. De Giorgi2, L. Fantini1, R. Galassi4, A. Moretti4, G. Gualtieri1, E. Scarpi3, D. Amadori2, G. Paganelli1 and F. Matteucci1 1Unità Operativa Medicina Nucleare Diagnostica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS, Meldola. 2Unità Operativa di Oncologia Medica Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS, Meldola. 3 Unità operativa Biostatistica e Data manager, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS, Meldola. 4 Unità Operativa Medicina Nucleare, Dipartimento di Radiologia, Ospedale Morgagni-Pierantoni, Forlì.

2 Disclosure Slide La sottoscritta Paola Caroli DICHIARA che, nell esercizio delle funzioni di Relatore, NON E in alcun modo portatore di interessi commerciali propri o di terzi; dichiara altresì che gli eventuali rapporti avuti negli ultimi due anni con soggetti portatori di interessi commerciali non sono tali da permettere a tali soggetti di influenzare le proprie funzioni al fine di trarne vantaggio.

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4 mcrpc (metastatic sintomatic castration resistant prostate cancer) Bevacizumab Abiraterone Sutent Enzalutamide (MDV 3100) Sorafenib Trastuzumab Radium-223 Acido Zoledronico Denosumab Sipuleucel-T Ipilimumab

5 Enzalutamide

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8 Aim We analyzes the role of 18F-FCH-PET/CT in the early treatment evaluation and outcome prediction in patients with metastatic castration-resistant prostate cancer (CRPC) treated with enzalutamide.

9 Patients and methods 34 patients, median age 72 years (range, years) were treated with enzalutamide. FCH-PET/CT was done at baseline and was repeated after 4-6 weeks. Pts were evaluated monthly for serological PSA response. FCH-PET/CT scans were performed using a Discovery LS camera (GE Medical Systems, Waukesha, WI).

10 Patients and methods Median age (range), years ECOG Performance Status (43-91) % 8% Gleason score 7 >7 Unknown % 58% 11% % 50% 11% 8% % 25% 33% % 39% Previous abiraterone No Yes Metastatic Sites Bone Node Lung Liver No. of line of therapy after docetaxel Second-line Third-line Forth or more line Baseline PSA level Median (range), ng/ml 105 ( )

11 Results Response at FCH PET/CT Imaging Study Non-Progressing Complete Response (CR) 0 Partial Response (PR) 7 Stable Disease (SD) 7 Progression Disease (PD) Progressing 20

12 Results PSA decrease PSA increase Total

13 Comparison of FCH PET/CT in Non-Progressing and Progressing patients & PSA response Response at FCH PET/CT Imaging Study PSA decrease PSA increase Total Non-Progressing (SD, PR) Progressing (PD) Total in biochemical PD at 2 months 7 in biochemical SD/PR at 2 months

14 Progression-free survival as a function of PET outcome 1.00 Overall survival as a function of PET outcome PFS SD, PR PD SD, PR months 9 12 OS 0.00 PD months

15 74 yo, RP 2011, PSA increase in 2013, docetaxel then Enzalutamide.

16 PR at FCH-PET/CT after 4 weeks

17 09/ yo, bone localizzation RT, Enantone, docetaxel and Enzalutamide 17

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19 68 yo, RP in 2009, Casodex, Docetaxel, Abiraterone and Enzalutamide 05/ /2013

20 Conclusion The combination of FCH PET/CT and PSA evaluation could be a valid tool for early prediction of outcome and to monitor response to therapy in mcrpc patients and to optimize the use of this high-cost treatment. It is still too early to propose FCH PET/CT for routine use in clinical practice, and further studies are needed in larger populations, especially those with earlier stage disease.

21 GRAZIE PER L ATTENZIONE

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24 Early FCH-PET/CT assessment may predict the clinical outcome of patients with mcrpc treated with enzalutamide even if at the present time it does not seem to add value to the evaluation of PSA. Clinical conditions of this pts represents a limitation of the study

25 OS

26 PFS