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

Primary Purpose

Prostate Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-18 fluciclovine-PET/CT scan
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Routine F-18 fluciclovine-PET/CT scan

Research F-18 fluciclovine-PET/CT scan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2018
Last Updated
August 12, 2022
Sponsor
University of Arizona
Collaborators
Blue Earth Diagnostics, Banner University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03496844
Brief Title
Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma
Acronym
BoneMetPETCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Blue Earth Diagnostics, Banner University Medical Center

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine F-18 fluciclovine-PET/CT scan
Arm Type
No Intervention
Arm Description
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.
Arm Title
Research F-18 fluciclovine-PET/CT scan
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
F-18 fluciclovine-PET/CT scan
Other Intervention Name(s)
Axumin-PET scan
Intervention Description
PET/CT imaging with F-18 fluciclovine
Primary Outcome Measure Information:
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Diagnosed with prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Having a history of severe claustrophobia Weight exceeding 400lbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip H Kuo, MD, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hani Babiker, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to make individual participant data available to other researchers.

Learn more about this trial

Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

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