Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 27, 2021

Interventions

  • Diagnostic Test: F-18 fluciclovine-PET/CT scan
    • PET/CT imaging with F-18 fluciclovine

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Diagnosed with prostate cancer

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Arizona
  • Collaborator
    • Blue Earth Diagnostics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Phillip H Kuo, MD, PhD, Principal Investigator, University of Arizona
    • Hani Babiker, MD, Principal Investigator, University of Arizona

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