Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer

Inclusion Criteria

• •The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with biochemical recurrence (BCR) on the basis of:
• •1. Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) \[53\], or
• •2. Post radical prostatectomy (RP): EITHER two consecutive rises in PSA and final PSA \>0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
• •i. In addition, the subject post RP, should have a PSA doubling time of ≤15 months OR PSA level ≥1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.
• •The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
• •The subject is being considered for radical salvage therapy.
• •The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.
• •The subject's Eastern Cooperative Oncology Group \[ECOG\] performance status 0-2.
• •The subject should not have received androgen-deprivation therapy within 3 months of screening.
• •The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug).