Clinical Trial · NCT02578940

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

Overview

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

Sponsor

Blue Earth Diagnostics, LTD

Phase

Phase 3

Contacts

Fergus Gleeson, FRCP FRCR (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02578940

Drug / Compound

Fluciclovine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

The subject is being considered for radical salvage therapy.
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
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:
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).
The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
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.
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.

Exclusion

The subject has had a choline PET/CT scan within 3 months of the screening visit.
The subject has been previously included in this study.
The subject has bilateral hip prostheses.
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.

Patient Education

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