Trial Outcomes & Findings for Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer (NCT NCT02578940)
NCT ID: NCT02578940
Last Updated: 2019-10-07
Results Overview
The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
104 participants
Primary outcome timeframe
1 month
Results posted on
2019-10-07
Participant Flow
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.
Participant milestones
| Measure |
Single Arm
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Overall Study
STARTED
|
109
|
|
Overall Study
Received 18F-fluciclovine
|
104
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Single Arm
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Overall Study
Screening failure
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
Baseline characteristics by cohort
| Measure |
Single Arm
n=104 Participants
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
104 participants
n=5 Participants
|
|
Height
|
176.0 cm
n=5 Participants
|
|
Weight
|
82.80 Kg
n=5 Participants
|
|
Body Mass Index
|
26.50 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 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.
The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
Outcome measures
| Measure |
18F-Fluciclovine PET CT
n=104 Participants
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Impact on Patient Treatment /Management
Overall Evaluable Analysis Set · Patients with Revised Management Plan
|
66 Participants
|
|
Impact on Patient Treatment /Management
Overall Evaluable Analysis Set · No Revision to Management Plan
|
38 Participants
|
|
Impact on Patient Treatment /Management
Positive 18F-fluciclovine Scan · Patients with Revised Management Plan
|
53 Participants
|
|
Impact on Patient Treatment /Management
Positive 18F-fluciclovine Scan · No Revision to Management Plan
|
5 Participants
|
|
Impact on Patient Treatment /Management
Negative 18F-fluciclovine Scan · Patients with Revised Management Plan
|
13 Participants
|
|
Impact on Patient Treatment /Management
Negative 18F-fluciclovine Scan · No Revision to Management Plan
|
33 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: Full Analysis Set
To establish the proportion of patients who have a sustained response to radical salvage therapy.
Outcome measures
| Measure |
18F-Fluciclovine PET CT
n=104 Participants
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Response Rate to Radical Salvage Therapy
Salvage therapy all · Treatment response
|
43 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy all · Stable disease
|
5 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy all · Disease progression
|
8 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy guided by 18F-fluciclovine · Treatment response
|
15 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy guided by 18F-fluciclovine · Stable disease
|
0 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy guided by 18F-fluciclovine · Disease progression
|
2 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy not guided by 18F-fluciclovine · Treatment response
|
28 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy not guided by 18F-fluciclovine · Stable disease
|
5 Participants
|
|
Response Rate to Radical Salvage Therapy
Salvage therapy not guided by 18F-fluciclovine · Disease progression
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Full Analysis Set
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
Outcome measures
| Measure |
18F-Fluciclovine PET CT
n=104 Participants
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup 0 to 0.2 (ng/mL)
|
33.3 percentage of Detection Rate
Interval 13.3 to 59.0
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >0.2 to 0.5 (ng/mL)
|
25.9 percentage of Detection Rate
Interval 11.1 to 46.3
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >0.5 to 1.0 (ng/mL)
|
36.4 percentage of Detection Rate
Interval 10.9 to 69.2
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >1.0 to 2.0 (ng/mL)
|
20 percentage of Detection Rate
Interval 0.5 to 71.6
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >2.0 to 5.0 (ng/mL)
|
91.7 percentage of Detection Rate
Interval 73.0 to 99.0
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >5.0 to 10.0 (ng/mL)
|
90.9 percentage of Detection Rate
Interval 58.7 to 99.8
|
|
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA Subgroup >10 (ng/mL)
|
100 percentage of Detection Rate
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Treatment-emergent Adverse Events
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.
Outcome measures
| Measure |
18F-Fluciclovine PET CT
n=27 Participants
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
TEAEs Unrelated
|
18 Participants
|
|
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
TEAEs Possibly
|
8 Participants
|
|
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
TEAEs Probably
|
0 Participants
|
|
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
TEAEs Definitely
|
1 Participants
|
Adverse Events
18F-Fluciclovine PET CT
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
18F-Fluciclovine PET CT
n=104 participants at risk
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.96%
1/104 • 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
|
Other adverse events
| Measure |
18F-Fluciclovine PET CT
n=104 participants at risk
Single intravenous administration of 18F-Fluciclovine for PET Scan
18F-Fluciclovine PET CT: Radioligand for PET CT scanning
|
|---|---|
|
General disorders
APPLICATION SITE REACTION
|
2.9%
3/104 • Number of events 3 • 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
|
|
General disorders
FATIGUE
|
2.9%
3/104 • Number of events 3 • 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
|
|
General disorders
APPLICATION SITE ERYTHEMA
|
0.96%
1/104 • Number of events 1 • 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
|
|
General disorders
CATHETER SITE BRUISE
|
0.96%
1/104 • Number of events 1 • 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
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Nervous system disorders
HEADACHE
|
3.8%
4/104 • Number of events 4 • 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
|
|
Nervous system disorders
DIZZINESS
|
1.9%
2/104 • Number of events 2 • 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
|
|
Nervous system disorders
DYSGEUSIA
|
1.9%
2/104 • Number of events 2 • 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
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Nervous system disorders
PAROSMIA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.96%
1/104 • Number of events 1 • 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
|
|
Nervous system disorders
TREMOR
|
0.96%
1/104 • Number of events 1 • 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
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
2.9%
3/104 • Number of events 3 • 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
|
|
Investigations
BIOPSY PROSTATE
|
0.96%
1/104 • Number of events 1 • 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
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.96%
1/104 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.96%
1/104 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.96%
1/104 • Number of events 1 • 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
|
|
Infections and infestations
ORAL HERPES
|
0.96%
1/104 • Number of events 1 • 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
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.96%
1/104 • Number of events 1 • 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
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.96%
1/104 • Number of events 1 • 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
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL CONTUSION
|
0.96%
1/104 • Number of events 1 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOMA RECURRENT
|
0.96%
1/104 • Number of events 1 • 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
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.96%
1/104 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.96%
1/104 • Number of events 1 • 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
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.96%
1/104 • Number of events 1 • 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
|
|
Investigations
ELECTROCARDIOGRAM ABNORMAL
|
0.96%
1/104 • Number of events 1 • 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
|
|
Vascular disorders
HYPERTENSION
|
0.96%
1/104 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
NECK MASS
|
0.96%
1/104 • Number of events 1 • 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
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.96%
1/104 • Number of events 1 • 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
|
Additional Information
Peter Gardiner MB ChB, MRCP, FFPM
Blue Earth Diagnostics, Ltd.
Phone: 1-781-552-3403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place