Trial Outcomes & Findings for 18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies (NCT NCT04158245)
NCT ID: NCT04158245
Last Updated: 2025-09-22
Results Overview
To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
18F-fluciclovine PET Scan
Single intravenous administration of 18F-fluciclovine for positron emission computed tomography (PET) Scan.
18F-fluciclovine PET Scan: The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in prostate-specific antigen (PSA), allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
18F-fluciclovine PET Scan
Single intravenous administration of 18F-fluciclovine for positron emission computed tomography (PET) Scan.
18F-fluciclovine PET Scan: The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in prostate-specific antigen (PSA), allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies
Baseline characteristics by cohort
| Measure |
18F-fluciclovine PET Scan
n=9 Participants
Single intravenous administration of 18F-fluciclovine for PET Scan.
18F-fluciclovine PET Scan: The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
62.56 Years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Haemoglobin
|
12.23 g/dL
STANDARD_DEVIATION 1.73 • n=5 Participants
|
|
Platelets
|
257.56 cells/mcL
STANDARD_DEVIATION 105.58 • n=5 Participants
|
|
Calcium
|
9.31 mg/dL
STANDARD_DEVIATION 0.50 • n=5 Participants
|
|
Creatinine
|
1.15 mg/dL
STANDARD_DEVIATION 0.56 • n=5 Participants
|
|
Alkaline phosphatase
|
95.78 IU/L
STANDARD_DEVIATION 35.82 • n=5 Participants
|
|
Prostate-Specific Antigen
|
150 ng/mL
STANDARD_DEVIATION 399 • n=5 Participants
|
|
Testosterone
Testosterone undetectable
|
8 Participants
n=5 Participants
|
|
Testosterone
Testosterone detectable
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.
Outcome measures
| Measure |
18F-fluciclovine PET Scan
n=8 Participants
Single intravenous administration of 18F-fluciclovine for PET Scan.
18F-fluciclovine PET Scan: The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
|
|---|---|
|
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
Stable disease
|
5 Participants
|
|
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
Progressive disease
|
0 Participants
|
|
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
Partial response
|
3 Participants
|
|
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
Complete response
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksA comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with life prolonging therapies, and at 12 weeks after starting life prolonging therapies; and to correlate these changes with PSA response and progression after starting life prolonging therapies.
Outcome measures
| Measure |
18F-fluciclovine PET Scan
n=8 Participants
Single intravenous administration of 18F-fluciclovine for PET Scan.
18F-fluciclovine PET Scan: The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
|
|---|---|
|
PET Scan vs. Conventional CT and Bone Scan
PET scan positivity
|
8 Participants
|
|
PET Scan vs. Conventional CT and Bone Scan
Conventional CT scan positivity
|
3 Participants
|
|
PET Scan vs. Conventional CT and Bone Scan
Conventional bone scan positivity
|
8 Participants
|
|
PET Scan vs. Conventional CT and Bone Scan
PSA response
|
3 Participants
|
Adverse Events
18F-fluciclovine PET Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place