BoneMetPETCT: Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT03496844
• Collaborator: Blue Earth Diagnostics (Industry), Banner University Medical Center (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma	Diagnostic Test: F-18 fluciclovine-PET/CT scan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma
• Actual Study Start Date: Apr 15, 2018
• Actual Primary Completion Date: Apr 27, 2021
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Routine F-18 fluciclovine-PET/CT scan This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy.
Active Comparator: 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. 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.	Diagnostic Test: F-18 fluciclovine-PET/CT scan; PET/CT imaging with F-18 fluciclovine; Other Names: Axumin-PET scan

Outcome Measures

Primary Outcome Measures

1. True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy [1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male

2. Be ≥ 18 years of age

3. Diagnosed with prostate cancer

4. Be willing and able to provide informed consent

5. Be informed of the investigational nature of this study

Exclusion Criteria:

1. Having a history of severe claustrophobia

2. Weight exceeding 400lbs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724

Sponsors and Collaborators

• University of Arizona
• Blue Earth Diagnostics
• Banner University Medical Center

Investigators

• Principal Investigator: Phillip H Kuo, MD, PhD, University of Arizona
• Principal Investigator: Hani Babiker, MD, University of Arizona

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 4, 2020

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT03496844
• Other Study ID Numbers: 1803340164
• First Posted: Apr 12, 2018
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenocarcinoma; Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Research F-18 Fluciclovine-PET/CT Scan
Arm/Group Description	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
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Research F-18 Fluciclovine-PET/CT Scan
Arm/Group Description	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
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 33.3%
>=65 years	10 66.7%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	15 100%
Race/Ethnicity, Customized (Count of Participants)
White/Non-Hispanic	13 86.7%
White/Hispanic	2 13.3%
Region of Enrollment (participants) [Number]
United States	15 100%
Percentage of participants who underwent bone biopsy (Count of Participants)
with bone biopsy	13 86.7%
no bone biospy	2 13.3%

Outcome Measures

1. Primary Outcome

Title	True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Subjects who underwent bone biopsy

Arm/Group Title	Research F-18 Fluciclovine-PET/CT Scan
Arm/Group Description	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
Measure Participants	13
Total participants with bone biopsy	13 86.7%
Number of Participants with Positive Bone Biopsy on Pathology	7 46.7%
Number of Participants with Negative Bone Biopsy on Pathology	6 40%

Adverse Events

Time Frame	Adverse events were collected for 1 week after the PET/CT scan was completed.
Adverse Event Reporting Description	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Arm/Group Title	Research F-18 Fluciclovine-PET/CT Scan
Arm/Group Description	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
All Cause Mortality
	Research F-18 Fluciclovine-PET/CT Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Research F-18 Fluciclovine-PET/CT Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Research F-18 Fluciclovine-PET/CT Scan
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

Due to total lack of recruitment to cohort 1 consisting of Prostate Cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence, cohort 1 was dropped from the study. All consented subjects were in cohort 2. Data collected for subjects who underwent bone biopsy; 2 subjects were found to have non-bone sites more clinically appropriate to biopsy which resulted in less bone biopsy data to analyze.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.