Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
Condition: Cancer of the Prostate
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: 18F-Fluciclovine PET CT
Intervention description: Radioligand for PET CT scanning
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: PET Imaging study
Masking: None (Open Label)
Enrollment: 104.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer)
      on the clinical and treatment decision required for managing patients with biochemically
      recurrent prostate cancer (BCR) who are being considered for salvage treatment with the
      intention of providing disease cure. Also, this study will consolidate the information
      regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively
      followed patients at several centres in the UK and assess the effect of PSA level on the
      likelihood of detecting cancer lesions by 18F-fluciclovine
    

Eligibility criteria:

        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).

        Exclusion Criteria:

          -  The subject has been previously included in this study.

          -  The subject has received, or is scheduled to receive, another investigational
             medicinal product (IMP) from 1 month before to 1 week after administration of
             fluciclovine (18F) injection.

          -  The subject has known hypersensitivity to fluciclovine (18F) injection or any of its
             constituents.

          -  The subject has had a choline PET/CT scan within 3 months of the screening visit.

          -  The subject has bilateral hip prostheses.