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

University of Arizona

Status: Completed

Conditions: Prostate Adenocarcinoma

Treatments: Diagnostic Test: F-18 fluciclovine-PET/CT scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03496844

1803340164

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

Routine F-18 fluciclovine-PET/CT scan

No Intervention group

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.

Research F-18 fluciclovine-PET/CT scan

Active Comparator 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.

Treatment:

Diagnostic Test: F-18 fluciclovine-PET/CT scan