Trial Outcomes & Findings for 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment (NCT NCT02680041)
NCT ID: NCT02680041
Last Updated: 2019-01-28
Results Overview
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
2-22 days post PET CT
Results posted on
2019-01-28
Participant Flow
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.
Participant milestones
| Measure |
18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
|
|---|---|
|
Overall Study
STARTED
|
221
|
|
Overall Study
Received 18F-fluciclovine
|
213
|
|
Overall Study
COMPLETED
|
211
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
|
|---|---|
|
Overall Study
Withdrawal prior to 18F-fluciclovine PET
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Baseline characteristics by cohort
| Measure |
18F-fluciclovine PET CT
n=213 Participants
Single intravenous administration of 18F-fluciclovine PET/CT.
|
|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-22 days post PET CTPopulation: 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.
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=213 Participants
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
|
|---|---|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Overall Evaluable Analysis Set · No Revision to Management Plan
|
87 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Positive 18F-fluciclovine Scan · Patients with Revised Management Plan
|
88 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Positive 18F-fluciclovine Scan · No Revision to Management Plan
|
34 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Overall Evaluable Analysis Set · Patients with Revised Management Plan
|
126 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Negative 18F-fluciclovine Scan · Patients with Revised Management Plan
|
38 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Negative 18F-fluciclovine Scan · No Revision to Management Plan
|
53 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 211 participants completed the study (actual treatment assessed at study completion). Results also presented by 18F-fluciclovine PET CT results.
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.
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=211 Participants
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
|
|---|---|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Negative 18F fluciclovine Scan · Change from the revised management plan
|
33 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Negative 18F fluciclovine Scan · No change from the revised management plan
|
57 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Overall · Change from the revised management plan
|
80 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Overall · No change from the revised management plan
|
131 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Positive 18F fluciclovine Scan · Change from the revised management plan
|
47 Participants
|
|
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Positive 18F fluciclovine Scan · No change from the revised management plan
|
74 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Results presented for Full Analysis Set
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=213 Participants
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
|
|---|---|
|
The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
|
122 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Participants may have lesions detected in both regions (prostate/prostate bed and extra-prostatic).
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=213 Participants
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
|
|---|---|
|
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
Prostate or Prostate Bed
|
64 Participants
|
|
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
Extra-prostatic
|
80 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only scans graded as positive or negative by the adjudication panel were included in these calculations.
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
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=45 Participants
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
|
|---|---|
|
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
|
100 Percentage of scans
Interval 92.1 to 100.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only scans graded as positive or negative by the adjudication panel were included in these calculations.
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
Outcome measures
| Measure |
18F-fluciclovine PET CT
n=37 Participants
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
|
|---|---|
|
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
|
100 Percentage of scans
Interval 90.5 to 100.0
|
Adverse Events
18F-fluciclovine PET CT
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
18F-fluciclovine PET CT
n=213 participants at risk
Single intravenous administration of 18F-fluciclovine PET CT.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
6/213 • 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
Constipation
|
0.94%
2/213 • 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
Haematuria
|
0.94%
2/213 • 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
Nocturia
|
0.94%
2/213 • 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
Pollakiuria
|
0.94%
2/213 • 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 Incontinence
|
0.94%
2/213 • 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
Oedema peripheral
|
0.94%
2/213 • 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
|
2.8%
6/213 • 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.
|
|
Psychiatric disorders
Anxiety
|
0.94%
2/213 • 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)
Meningioma
|
0.94%
2/213 • 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
Urinary Tract Infection
|
0.94%
2/213 • 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
Hot flush
|
0.94%
2/213 • 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
Abdominal discomfort
|
0.47%
1/213 • 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
Abdominal pain
|
0.47%
1/213 • 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
|
0.47%
1/213 • 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
Inguinal hernia
|
0.47%
1/213 • 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
Nausea
|
0.47%
1/213 • 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
Dysuria
|
0.47%
1/213 • 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
Hypertonic bladder
|
0.47%
1/213 • 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
Micturition urgency
|
0.47%
1/213 • 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
Stress urinary incontinence
|
0.47%
1/213 • 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 retention
|
0.47%
1/213 • 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
Excercise tolerance decreased
|
0.47%
1/213 • 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
|
0.47%
1/213 • 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
Feeling cold
|
0.47%
1/213 • 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 extravasation
|
0.47%
1/213 • 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 pain
|
0.47%
1/213 • 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
Pyrexia
|
0.47%
1/213 • 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
|
0.47%
1/213 • 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
Hydrocephalus
|
0.47%
1/213 • 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
Lethargy
|
0.47%
1/213 • 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
Parkinson's disease
|
0.47%
1/213 • 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
Arthralgia
|
0.47%
1/213 • 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
Flank pain
|
0.47%
1/213 • 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
Intervertrabral disc degeneration
|
0.47%
1/213 • 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
Muscle spasms
|
0.47%
1/213 • 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
Muscular weakness
|
0.47%
1/213 • 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
Musculoskeletal stiffness
|
0.47%
1/213 • 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.
|
|
Psychiatric disorders
Emotional disorder
|
0.47%
1/213 • 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.
|
|
Psychiatric disorders
Insomnia
|
0.47%
1/213 • 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.
|
|
Psychiatric disorders
Listless
|
0.47%
1/213 • 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)
Adenocarcinoma of colon
|
0.47%
1/213 • 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)
Oesophageal carcinoma
|
0.47%
1/213 • 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
Rectal abscess
|
0.47%
1/213 • 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
|
0.47%
1/213 • 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 increased
|
0.47%
1/213 • 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 potassium increased
|
0.47%
1/213 • 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 urea increased
|
0.47%
1/213 • 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
Carbon dioxide decreased
|
0.47%
1/213 • 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
Waist circumference increased
|
0.47%
1/213 • 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.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.47%
1/213 • 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.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.47%
1/213 • 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.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.47%
1/213 • 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.
|
|
Reproductive system and breast disorders
Scrotal irritation
|
0.47%
1/213 • 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.
|
|
Cardiac disorders
Atrial fibrilation
|
0.47%
1/213 • 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.
|
|
Metabolism and nutrition disorders
Hyperchloreamia
|
0.47%
1/213 • 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
Skin lesion
|
0.47%
1/213 • 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 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.
- Publication restrictions are in place
Restriction type: OTHER