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Trial record 89 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)

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ClinicalTrials.gov Identifier: NCT02443571
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : October 26, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Prostatic Neoplasms
Intervention Radiation: Fluciclovine (18F)
Enrollment 714
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Recurrent Prostate Cancer Primary Prostate Cancer Other Cancers
Hide Arm/Group Description Recurrent Prostate Cancer Primary Prostate Cancer Other Cancers
Period Title: Overall Study
Started 596 95 23
Completed 596 95 23
Not Completed 0 0 0
Arm/Group Title Recurrent Prostate Cancer Primary Prostate Cancer Other Cancers Total
Hide Arm/Group Description Recurrent Prostate Cancer Primary Prostate Cancer Other Cancers Total of all reporting groups
Overall Number of Baseline Participants 596 95 23 714
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 596 participants 95 participants 23 participants 714 participants
67
(42 to 90)
65
(44 to 88)
61
(34 to 89)
66
(34 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants 95 participants 23 participants 714 participants
Female
0
   0.0%
0
   0.0%
16
  69.6%
16
   2.2%
Male
596
 100.0%
95
 100.0%
7
  30.4%
698
  97.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants 95 participants 23 participants 714 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
26
   4.4%
0
   0.0%
3
  13.0%
29
   4.1%
White
186
  31.2%
0
   0.0%
17
  73.9%
203
  28.4%
More than one race
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.1%
Unknown or Not Reported
382
  64.1%
95
 100.0%
3
  13.0%
480
  67.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants 95 participants 23 participants 714 participants
United States
137
  23.0%
10
  10.5%
21
  91.3%
168
  23.5%
Norway
371
  62.2%
85
  89.5%
2
   8.7%
458
  64.1%
Italy
88
  14.8%
0
   0.0%
0
   0.0%
88
  12.3%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Hide Description Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time Frame Up to 35 days post Fluciclovine 18F
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have received at least one dose of Fluciclovine 18F
Arm/Group Title Recurrent Prostate Cancer Primary Prostate Cancer Other Cancers
Hide Arm/Group Description:
Recurrent Prostate Cancer
Primary Prostate Cancer
Other Cancers
Overall Number of Participants Analyzed 596 95 23
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Emergent Adverse Events
32
   5.4%
2
   2.1%
8
  34.8%
Treatment Emergent Serious Adverse Events
1
   0.2%
1
   1.1%
0
   0.0%
2.Primary Outcome
Title Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Hide Description Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Time Frame Up to 1 year post Fluciclovine 18F
Hide Outcome Measure Data
Hide Analysis Population Description

Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings.

When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique.

Arm/Group Title Recurrent Prostate Cancer
Hide Arm/Group Description:
Recurrent prostate Cancer
Overall Number of Participants Analyzed 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Subject PPV Number Analyzed 143 participants
82.4
(74.3 to 88.7)
Extraprostatic Region PPV Number Analyzed 44 participants
92.3
(79.1 to 98.4)
Prostate & Prostate Bed Region PPV Number Analyzed 127 participants
71.8
(62.1 to 80.3)
3.Primary Outcome
Title Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Hide Description Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Time Frame Up to 1 year post Fluciclovine 18F
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Prostate Cancer
Hide Arm/Group Description:
Primary Prostate Cancer
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(93.7 to 100)
4.Secondary Outcome
Title Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Hide Description

Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan.

Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan.

Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan.

Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.

Time Frame Up to 1 year post Fluciclovine 18F
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recurrent Prostate Cancer
Hide Arm/Group Description:
Recurrent Prostate Cancer
Overall Number of Participants Analyzed 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages
Detection Rate
82.4
(74.6 to 88.6)
Sensitivity
94.7
(88.0 to 98.3)
Specificity
54.8
(36.0 to 72.7)
Negative Predictive Value
77.3
(54.6 to 92.2)
5.Secondary Outcome
Title Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Hide Description

Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan.

Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan.

Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan.

Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.

Time Frame Up to 1 year post Fluciclovine 18F
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Prostate Cancer
Hide Arm/Group Description:
Primary Prostate Cancer
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Detection Rate
93.4
(84.1 to 98.2)
Sensitivity
93.4
(84.1 to 98.2)
Time Frame All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-Fluciclovine PET
Hide Arm/Group Description 18F-Fluciclovine PET
All-Cause Mortality
18F-Fluciclovine PET
Affected / at Risk (%)
Total   0/714 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
18F-Fluciclovine PET
Affected / at Risk (%)
Total   2/714 (0.28%) 
Injury, poisoning and procedural complications   
Post Procedural Haemorrhage * 1  1/714 (0.14%) 
Post Procedural Pulmonary Embolism * 1  1/714 (0.14%) 
Investigations   
Blood Pressure Decreased * 1  1/714 (0.14%) 
Haemoglobin decreased * 1  1/714 (0.14%) 
Vascular disorders   
Hypertension * 1  1/714 (0.14%) 
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
18F-Fluciclovine PET
Affected / at Risk (%)
Total   9/714 (1.26%) 
General disorders   
Injection site extravasation * 1  9/714 (1.26%) 
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-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: Chief Medical Officer
Organization: Blue Earth Diagnostics Ltd.
Phone: +44 (0) 1865 784 186
EMail: contact@blueearthdx.com
Layout table for additonal information
Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT02443571     History of Changes
Other Study ID Numbers: Fluciclovine (18F) - BED - 001
First Submitted: May 11, 2015
First Posted: May 14, 2015
Results First Submitted: May 26, 2017
Results First Posted: October 26, 2018
Last Update Posted: December 18, 2018