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

Study Description

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Brief Summary:

The main aim is to assess the impact of using fluciclovine (18F) (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 fluciclovine (18F).

Condition or disease	Intervention/treatment	Phase
Cancer of the Prostate	Radiation: Fluciclovine 18 F	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	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
Study Start Date :	November 2015
Actual Primary Completion Date :	May 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Single arm	Radiation: Fluciclovine 18 F; Radioligand for PET CT scanning; Other Name: FACBC

Outcome Measures

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Primary Outcome Measures :

1. Impact on patient treatment /management [ Time Frame: 1 month ]
   The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.

Secondary Outcome Measures :

1. Response rate to radical salvage therapy [ Time Frame: 7 months ]
   To establish the proportion of patients who have a sustained response to radical salvage therapy.
2. Diagnostic performance of the fluciclovine (18F) PET/CT scan [ Time Frame: 1 month ]
   Diagnostic performance will be assessed by analysing sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using patient and lesion based analyses.
3. Effect of PSA levels on detection of recurrent cancer by the fluciclovine (18F) PET/CT scan [ Time Frame: 1 month ]
   PSA levels in relation to scan positivity will be analysed to determine the optimal PSA threshold for detecting recurrent PCa by fluciclovine (18F) PET/CT.
4. Assessment of safety and tolerability [ Time Frame: 1 month ]
   Safety will be 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 fluciclovine (18F) injection throughout the study period.
5. Comparison of detection rates for fluciclovine (18F) PET/CT and choline PET/CT (in the patient subset who receive choline as standard care) [ Time Frame: 1 month ]
   The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of choline PET will be assessed using patient and lesion based analyses, and compared to that of fluciclovine (18F) PET/CT.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United Kingdom
Mount Vernon Cancer Centre, Mount Vernon Hospital
Northwood, Middlesex, United Kingdom, HA6 2RN
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
St James Institute of Oncology
Leeds, Yorkshire, United Kingdom, LS9 7TF
Greater Glasgow & Clyde NHS Trust
Glasgow, United Kingdom
University College London Hospital
London, United Kingdom, NW1 2BU
St Thomas' Hospital
London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Blue Earth Diagnostics

Innovate UK

Syne Qua Non Limited

IND 2 Results LLC

Investigators

Principal Investigator:	Fergus Gleeson, FRCP FRCR	The Oxford University Hospitals NHS Trust

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Blue Earth Diagnostics
ClinicalTrials.gov Identifier:	NCT02578940 History of Changes
Other Study ID Numbers:	BED-004
First Posted:	October 19, 2015
Last Update Posted:	July 5, 2017
Last Verified:	July 2017

Additional relevant MeSH terms:

Prostatic Neoplasms; Recurrence; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site	Neoplasms; Genital Diseases, Male; Prostatic Diseases; Disease Attributes; Pathologic Processes