Trial Outcomes & Findings for Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma (NCT NCT03496844)

Last Updated: 2022-08-16

Results Overview

True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

1 year

Results posted on

2022-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Research F-18 Fluciclovine-PET/CT Scan This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Research F-18 Fluciclovine-PET/CT Scan n=15 Participants This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized White/Non-Hispanic	13 Participants n=5 Participants
Race/Ethnicity, Customized White/Hispanic	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Percentage of participants who underwent bone biopsy with bone biopsy	13 Participants n=5 Participants
Percentage of participants who underwent bone biopsy no bone biospy	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Subjects who underwent bone biopsy

True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy

Outcome measures

Outcome measures
Measure	Research F-18 Fluciclovine-PET/CT Scan n=13 Participants This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine
True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy Total participants with bone biopsy	13 participants
True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy Number of Participants with Positive Bone Biopsy on Pathology	7 participants
True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy Number of Participants with Negative Bone Biopsy on Pathology	6 participants

Adverse Events

Research F-18 Fluciclovine-PET/CT 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

Phillip Kuo, MD PhD

University of Arizona

Phone: 5206268318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place