Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

NCT03496844 | Completed Results FDA Device

• 1 other identifier: 1803340164
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to 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

  1 year

Study Arms (2)

Routine F-18 fluciclovine-PET/CT scan

NO INTERVENTION

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.

Research F-18 fluciclovine-PET/CT scan

ACTIVE COMPARATOR

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

Interventions

F-18 fluciclovine-PET/CT scan DIAGNOSTIC_TEST

PET/CT imaging with F-18 fluciclovine

Also known as: Axumin-PET scan

Research F-18 fluciclovine-PET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Diagnosed with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Be ≥ 18 years of age
• Diagnosed with prostate cancer
• Be willing and able to provide informed consent
• Be informed of the investigational nature of this study

You may not qualify if:

• Having a history of severe claustrophobia
• Weight exceeding 400lbs

Sponsors & Collaborators

• University of Arizona: lead
• Blue Earth Diagnostics: collaborator
• Banner University Medical Center: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Limitations and 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.

Results Point of Contact

• Title: Phillip Kuo, MD PhD
• Organization: University of Arizona

pkuo@arizona.edu

5206268318

Study Officials

• Phillip H Kuo, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Hani Babiker, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: April 15, 2018
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: August 16, 2022
• Results First Posted: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)