Trial Outcomes & Findings for Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone (NCT NCT03707184)

Last Updated: 2024-11-29

Results Overview

Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

Results posted on

2024-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Fluciclovine F18, PET/CT) Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT scan
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (Fluciclovine F18, PET/CT) Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT scan
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Fluciclovine F18, PET/CT) n=17 Participants Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT scan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	70.41 years STANDARD_DEVIATION 6.19 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

Population: The \[18F\]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types.

Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

Outcome measures

Outcome measures
Measure	Diagnostic (Fluciclovine F18, PET/CT) n=19 Lesions Participants receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT scan
Mean Standardized Uptake Value (SUVmean) by Lesion Type Osteoblastic Dense	1.91 SUV by body weight (kg) Standard Deviation 0.69
Mean Standardized Uptake Value (SUVmean) by Lesion Type Osteoblastic Ground Glass	2.36 SUV by body weight (kg) Standard Deviation 1.12
Mean Standardized Uptake Value (SUVmean) by Lesion Type Osteoblastic Mixed	2.63 SUV by body weight (kg) Standard Deviation 1.26
Mean Standardized Uptake Value (SUVmean) by Lesion Type Osteolytic	3.05 SUV by body weight (kg) Standard Deviation 0.43

PRIMARY outcome

Timeframe: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

Outcome measures

Outcome measures
Measure	Diagnostic (Fluciclovine F18, PET/CT) n=19 lesions Participants receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT scan
Maximum Standardized Uptake Value (SUVmax) by Lesion Type Osteoblastic Dense	4.80 SUV by body weight (kg) Standard Deviation 1.53
Maximum Standardized Uptake Value (SUVmax) by Lesion Type Osteoblastic Ground Glass	7.17 SUV by body weight (kg) Standard Deviation 3.75
Maximum Standardized Uptake Value (SUVmax) by Lesion Type Osteoblastic Mixed	8.39 SUV by body weight (kg) Standard Deviation 5.61
Maximum Standardized Uptake Value (SUVmax) by Lesion Type Osteolytic	10.02 SUV by body weight (kg) Standard Deviation 3.33

Adverse Events

Diagnostic (Fluciclovine F18, PET/CT)

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

Sam Mitchell

Huntsman Cancer Institute, Center for Quantitative Cancer Imaging

Phone: 8012136110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place