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

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ClinicalTrials.gov Identifier: NCT02578940
Recruitment Status : Completed
First Posted : October 19, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
Innovate UK
Syne Qua Non Limited
IND 2 Results LLC
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cancer of the Prostate
Intervention Drug: 18F-Fluciclovine PET CT
Enrollment 104
Recruitment Details This study was conducted between 27 November 2015 (first patient, screening visit) and 22 June 2018 (last patient, completed) at seven sites (one did not enrol) in the UK.
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description

Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

Period Title: Overall Study
Started 109
Received 18F-fluciclovine 104
Completed 103
Not Completed 6
Reason Not Completed
Screening failure             5
Lost to Follow-up             1
Arm/Group Title Single Arm
Hide Arm/Group Description

Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 104 participants
67.0
(49 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
0
   0.0%
Male
104
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
104
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 104 participants
104
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 104 participants
176.0
(157 to 197)
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 104 participants
82.80
(56.0 to 134.0)
Body Mass Index  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 104 participants
26.50
(19.6 to 42.3)
1.Primary Outcome
Title Impact on Patient Treatment /Management
Hide Description The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
Time Frame 1 month
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Hide Analysis Population Description
For the primary analysis population, of the 104 patients included in the EAS, 58 patients with a positive 18F fluciclovine scan and 46 patients with a negative 18F fluciclovine scan had a pre-18F fluciclovine PET/CT management plan.
Arm/Group Title 18F-Fluciclovine PET CT
Hide Arm/Group Description:

Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

Overall Number of Participants Analyzed 104
Measure Type: Count of Participants
Unit of Measure: Participants
Overall Evaluable Analysis Set Number Analyzed 104 participants
Patients with Revised Management Plan
66
  63.5%
No Revision to Management Plan
38
  36.5%
Positive 18F-fluciclovine Scan Number Analyzed 58 participants
Patients with Revised Management Plan
53
  91.4%
No Revision to Management Plan
5
   8.6%
Negative 18F-fluciclovine Scan Number Analyzed 46 participants
Patients with Revised Management Plan
13
  28.3%
No Revision to Management Plan
33
  71.7%
2.Secondary Outcome
Title Response Rate to Radical Salvage Therapy
Hide Description To establish the proportion of patients who have a sustained response to radical salvage therapy.
Time Frame 7 months
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title 18F-fluciclovine PET CT
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Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

Overall Number of Participants Analyzed 104
Measure Type: Count of Participants
Unit of Measure: Participants
Salvage therapy all Number Analyzed 56 participants
Treatment response
43
  76.8%
Stable disease
5
   8.9%
Disease progression
8
  14.3%
Salvage therapy guided by 18F-fluciclovine Number Analyzed 17 participants
Treatment response
15
  88.2%
Stable disease
0
   0.0%
Disease progression
2
  11.8%
Salvage therapy not guided by 18F-fluciclovine Number Analyzed 39 participants
Treatment response
28
  71.8%
Stable disease
5
  12.8%
Disease progression
6
  15.4%
3.Secondary Outcome
Title PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
Hide Description 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
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title 18F-Fluciclovine PET CT
Hide Arm/Group Description:

Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

Overall Number of Participants Analyzed 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Detection Rate
PSA Subgroup 0 to 0.2 (ng/mL) Number Analyzed 18 participants
33.3
(13.3 to 59.0)
PSA Subgroup >0.2 to 0.5 (ng/mL) Number Analyzed 27 participants
25.9
(11.1 to 46.3)
PSA Subgroup >0.5 to 1.0 (ng/mL) Number Analyzed 11 participants
36.4
(10.9 to 69.2)
PSA Subgroup >1.0 to 2.0 (ng/mL) Number Analyzed 5 participants
20
(0.5 to 71.6)
PSA Subgroup >2.0 to 5.0 (ng/mL) Number Analyzed 24 participants
91.7
(73.0 to 99.0)
PSA Subgroup >5.0 to 10.0 (ng/mL) Number Analyzed 11 participants
90.9
(58.7 to 99.8)
PSA Subgroup >10 (ng/mL) Number Analyzed 8 participants
100
(63.1 to 100.0)
4.Secondary Outcome
Title Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-emergent Adverse Events
Arm/Group Title Treatment-emergent Adverse Events
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Number of Subject from SAS who experienced Treatment-emergent Adverse Events
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs Unrelated
18
  66.7%
TEAEs Possibly
8
  29.6%
TEAEs Probably
0
   0.0%
TEAEs Definitely
1
   3.7%
Time Frame As specified in the Statistical Analysis Plan, results are presented as only those treatment-emergent adverse events which occurred up to 42 days after the 18F fluciclovine administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-Fluciclovine PET CT
Hide Arm/Group Description

Single intravenous administration of 18F-Fluciclovine for PET Scan

18F-Fluciclovine PET CT: Radioligand for PET CT scanning

All-Cause Mortality
18F-Fluciclovine PET CT
Affected / at Risk (%)
Total   0/104 (0.00%)    
Hide Serious Adverse Events
18F-Fluciclovine PET CT
Affected / at Risk (%) # Events
Total   1/104 (0.96%)    
Renal and urinary disorders   
Urinary tract obstruction  1  1/104 (0.96%) 
1
Term from vocabulary, MedDRA version 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18F-Fluciclovine PET CT
Affected / at Risk (%) # Events
Total   31/104 (29.81%)    
Gastrointestinal disorders   
DIARRHOEA  1  1/104 (0.96%)  1
DYSPEPSIA  1  1/104 (0.96%)  1
General disorders   
APPLICATION SITE REACTION  1  3/104 (2.88%)  3
FATIGUE  1  3/104 (2.88%)  3
APPLICATION SITE ERYTHEMA  1  1/104 (0.96%)  1
CATHETER SITE BRUISE  1  1/104 (0.96%)  1
INJECTION SITE ERYTHEMA  1  1/104 (0.96%)  1
Infections and infestations   
ORAL HERPES  1  1/104 (0.96%)  1
UPPER RESPIRATORY TRACT INFECTION  1  1/104 (0.96%)  1
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/104 (0.96%)  1
Injury, poisoning and procedural complications   
POST PROCEDURAL CONTUSION  1  1/104 (0.96%)  1
Investigations   
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  3/104 (2.88%)  3
BIOPSY PROSTATE  1  1/104 (0.96%)  1
BLOOD LACTATE DEHYDROGENASE INCREASED  1  1/104 (0.96%)  1
ELECTROCARDIOGRAM ABNORMAL  1  1/104 (0.96%)  1
Musculoskeletal and connective tissue disorders   
GROIN PAIN  1  1/104 (0.96%)  1
MYALGIA  1  1/104 (0.96%)  1
NECK PAIN  1  1/104 (0.96%)  1
NECK MASS  1  1/104 (0.96%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MELANOMA RECURRENT  1  1/104 (0.96%)  1
Nervous system disorders   
HEADACHE  1  4/104 (3.85%)  4
DIZZINESS  1  2/104 (1.92%)  2
DYSGEUSIA  1  2/104 (1.92%)  2
HYPOAESTHESIA  1  1/104 (0.96%)  1
PAROSMIA  1  1/104 (0.96%)  1
RESTLESS LEGS SYNDROME  1  1/104 (0.96%)  1
TREMOR  1  1/104 (0.96%)  1
Renal and urinary disorders   
URINARY TRACT OBSTRUCTION  1  1/104 (0.96%)  1
Respiratory, thoracic and mediastinal disorders   
PULMONARY MASS  1  1/104 (0.96%)  1
Skin and subcutaneous tissue disorders   
ERYTHEMA  1  1/104 (0.96%)  1
Vascular disorders   
HYPERTENSION  1  1/104 (0.96%)  1
1
Term from vocabulary, MedDRA version 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Gardiner MB ChB, MRCP, FFPM
Organization: Blue Earth Diagnostics, Ltd.
Phone: 1-781-552-3403
EMail: P.Gardiner@blueearthDx.com
Layout table for additonal information
Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT02578940    
Other Study ID Numbers: BED-004
First Submitted: October 15, 2015
First Posted: October 19, 2015
Results First Submitted: August 9, 2019
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019