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

Study Overview
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Brief Summary
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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

Detailed Description
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Proposed Research In the setting of growing single-centre evidence of superior diagnostic performance of 18F-fluciclovine PET/CT in BCR, our primary aim is to assess its clinical impact on treatment decisions in a multi-centre study in patients with BCR being considered for radical salvage treatment (with curative intent). In addition, we aim to further characterise its diagnostic performance, afforded by larger numbers of patients from multi-centre recruitment. We also aim to assess the effect of PSA level on probability of lesion detection by 18F-fluciclovine.

Official Title
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A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment

Conditions
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Cancer of the Prostate

Intervention / Treatment
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* Drug: 18F-Fluciclovine PET CT


Participation Criteria
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Eligibility Criteria
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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: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: PET Imaging study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Single intravenous administration of 18F-Fluciclovine for PET Scan | Drug: 18F-Fluciclovine PET CT<br>* Radioligand for PET CT scanning<br>* Other names: FACBC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on Patient Treatment /Management | The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate to Radical Salvage Therapy | To establish the proportion of patients who have a sustained response to radical salvage therapy. | 7 months | 
| PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR | PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT | 1 month | 
| Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT. | Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period. | 1 month |