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18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment (LOCATE)

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ClinicalTrials.gov Identifier: NCT02680041
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
American College of Radiology
IND 2 Results LLC
Syne Qua Non Limited
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 Prostate Cancer
Intervention Drug: 18F-fluciclovine PET CT
Enrollment 221
Recruitment Details The study was conducted between 01 June 2016 (first patient, screening visit) and 01 November 2017 (last patient, last contact) at 17 sites in the USA. Overall 17 sites were initiated, of which 15 sites enrolled patients.
Pre-assignment Details  
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description Single intravenous administration of 18F-fluciclovine PET CT.
Period Title: Overall Study
Started 221
Received 18F-fluciclovine 213
Completed 211
Not Completed 10
Reason Not Completed
Withdrawal prior to 18F-fluciclovine PET             8
Lost to Follow-up             2
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description Single intravenous administration of 18F-fluciclovine PET/CT.
Overall Number of Baseline Participants 213
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 213 participants
67.0
(46 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
Female
0
   0.0%
Male
213
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
Hispanic or Latino
9
   4.2%
Not Hispanic or Latino
202
  94.8%
Unknown or Not Reported
2
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
American Indian or Alaska Native
1
   0.5%
Asian
3
   1.4%
Native Hawaiian or Other Pacific Islander
2
   0.9%
Black or African American
17
   8.0%
White
188
  88.3%
More than one race
0
   0.0%
Unknown or Not Reported
2
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 213 participants
213
1.Primary Outcome
Title The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Hide Description The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Time Frame 2-22 days post PET CT
Hide Outcome Measure Data
Hide Analysis Population Description
For the primary analysis population, of the 213 patients included in the EAS, 122 patients with a positive 18F-fluciclovine scan and 91 patients with a negative 18F-fluciclovine scan had a pre 18F-fluciclovine PET/CT treatment management plan.
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:

Single intravenous administration of 18F-fluciclovine PET CT.

18F-fluciclovine PET CT: Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment

Overall Number of Participants Analyzed 213
Measure Type: Count of Participants
Unit of Measure: Participants
Overall Evaluable Analysis Set Number Analyzed 213 participants
Patients with Revised Management Plan
126
  59.2%
No Revision to Management Plan
87
  40.8%
Positive 18F-fluciclovine Scan Number Analyzed 122 participants
Patients with Revised Management Plan
88
  72.1%
No Revision to Management Plan
34
  27.9%
Negative 18F-fluciclovine Scan Number Analyzed 91 participants
Patients with Revised Management Plan
38
  41.8%
No Revision to Management Plan
53
  58.2%
2.Secondary Outcome
Title The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Hide Description

The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up.

Investigators were instructed to assess any clinically significant change from the revised management plan.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

211 participants completed the study (actual treatment assessed at study completion).

Results also presented by 18F-fluciclovine PET CT results.

Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:
Single intravenous administration of 18F-fluciclovine PET CT.
Overall Number of Participants Analyzed 211
Measure Type: Count of Participants
Unit of Measure: Participants
Overall Number Analyzed 211 participants
Change from the revised management plan
80
  37.9%
No change from the revised management plan
131
  62.1%
Positive 18F fluciclovine Scan Number Analyzed 121 participants
Change from the revised management plan
47
  38.8%
No change from the revised management plan
74
  61.2%
Negative 18F fluciclovine Scan Number Analyzed 90 participants
Change from the revised management plan
33
  36.7%
No change from the revised management plan
57
  63.3%
3.Secondary Outcome
Title The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
Hide Description The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Results presented for Full Analysis Set
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:
Single intravenous administration of 18F-fluciclovine PET CT.
Overall Number of Participants Analyzed 213
Measure Type: Count of Participants
Unit of Measure: Participants
122
  57.3%
4.Secondary Outcome
Title The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population
Hide Description The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants may have lesions detected in both regions (prostate/prostate bed and extra-prostatic).
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:
Single intravenous administration of 18F-fluciclovine PET CT.
Overall Number of Participants Analyzed 213
Measure Type: Count of Participants
Unit of Measure: Participants
Prostate or Prostate Bed
64
  30.0%
Extra-prostatic
80
  37.6%
5.Secondary Outcome
Title The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Hide Description Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only scans graded as positive or negative by the adjudication panel were included in these calculations.
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:
Single intravenous administration of 18F-fluciclovine PET CT.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of scans
100
(92.1 to 100.0)
6.Secondary Outcome
Title The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Hide Description Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only scans graded as positive or negative by the adjudication panel were included in these calculations.
Arm/Group Title 18F-fluciclovine PET CT
Hide Arm/Group Description:
Single intravenous administration of 18F-fluciclovine PET CT.
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of scans
100
(90.5 to 100.0)
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 PET CT.
All-Cause Mortality
18F-fluciclovine PET CT
Affected / at Risk (%)
Total   0/213 (0.00%) 
Hide Serious Adverse Events
18F-fluciclovine PET CT
Affected / at Risk (%)
Total   0/213 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18F-fluciclovine PET CT
Affected / at Risk (%)
Total   44/213 (20.66%) 
Cardiac disorders   
Atrial fibrilation  1  1/213 (0.47%) 
Gastrointestinal disorders   
Diarrhoea  1  6/213 (2.82%) 
Constipation  1  2/213 (0.94%) 
Abdominal discomfort  1  1/213 (0.47%) 
Abdominal pain  1  1/213 (0.47%) 
Dyspepsia  1  1/213 (0.47%) 
Inguinal hernia  1  1/213 (0.47%) 
Nausea  1  1/213 (0.47%) 
General disorders   
Oedema peripheral  1  2/213 (0.94%) 
Excercise tolerance decreased  1  1/213 (0.47%) 
Fatigue  1  1/213 (0.47%) 
Feeling cold  1  1/213 (0.47%) 
Injection site extravasation  1  1/213 (0.47%) 
Injection site pain  1  1/213 (0.47%) 
Pyrexia  1  1/213 (0.47%) 
Infections and infestations   
Urinary Tract Infection  1  2/213 (0.94%) 
Rectal abscess  1  1/213 (0.47%) 
Investigations   
Blood creatine phosphokinase increased  1  1/213 (0.47%) 
Blood creatine increased  1  1/213 (0.47%) 
Blood potassium increased  1  1/213 (0.47%) 
Blood urea increased  1  1/213 (0.47%) 
Carbon dioxide decreased  1  1/213 (0.47%) 
Waist circumference increased  1  1/213 (0.47%) 
Metabolism and nutrition disorders   
Hyperchloreamia  1  1/213 (0.47%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/213 (0.47%) 
Flank pain  1  1/213 (0.47%) 
Intervertrabral disc degeneration  1  1/213 (0.47%) 
Muscle spasms  1  1/213 (0.47%) 
Muscular weakness  1  1/213 (0.47%) 
Musculoskeletal stiffness  1  1/213 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Meningioma  1  2/213 (0.94%) 
Adenocarcinoma of colon  1  1/213 (0.47%) 
Oesophageal carcinoma  1  1/213 (0.47%) 
Nervous system disorders   
Headache  1  6/213 (2.82%) 
Dysgeusia  1  1/213 (0.47%) 
Hydrocephalus  1  1/213 (0.47%) 
Lethargy  1  1/213 (0.47%) 
Parkinson's disease  1  1/213 (0.47%) 
Psychiatric disorders   
Anxiety  1  2/213 (0.94%) 
Emotional disorder  1  1/213 (0.47%) 
Insomnia  1  1/213 (0.47%) 
Listless  1  1/213 (0.47%) 
Renal and urinary disorders   
Haematuria  1  2/213 (0.94%) 
Nocturia  1  2/213 (0.94%) 
Pollakiuria  1  2/213 (0.94%) 
Urinary Incontinence  1  2/213 (0.94%) 
Dysuria  1  1/213 (0.47%) 
Hypertonic bladder  1  1/213 (0.47%) 
Micturition urgency  1  1/213 (0.47%) 
Stress urinary incontinence  1  1/213 (0.47%) 
Urinary retention  1  1/213 (0.47%) 
Reproductive system and breast disorders   
Breast tenderness  1  1/213 (0.47%) 
Gynaecomastia  1  1/213 (0.47%) 
Nipple pain  1  1/213 (0.47%) 
Scrotal irritation  1  1/213 (0.47%) 
Skin and subcutaneous tissue disorders   
Skin lesion  1  1/213 (0.47%) 
Vascular disorders   
Hot flush  1  2/213 (0.94%) 
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 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.
Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
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: NCT02680041    
Other Study ID Numbers: BED003
First Submitted: January 15, 2016
First Posted: February 11, 2016
Results First Submitted: October 31, 2018
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019