Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

Phase 2

Completed

Conditions: Metastatic Prostate Carcinoma
Prostate Carcinoma Metastatic in the Bone
Stage IV Prostate Cancer

Interventions: Procedure: Computed Tomography
Drug: Fluciclovine F18
Procedure: Positron Emission Tomography

Registration Number: NCT03707184

Lead Sponsor: University of Utah

Brief Summary: This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed Description: PRIMARY OBJECTIVES:

I. Abnormal fluciclovine F18 (\[18F\] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 17

Inclusion Criteria

Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Exclusion Criteria

Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
Patients who require monitored anesthesia for PET scanning.
Patients who are too claustrophobic to undergo PET scanning.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluciclovine F18, PET/CT)	Positron Emission Tomography	Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.
Diagnostic (fluciclovine F18, PET/CT)	Computed Tomography	Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.
Diagnostic (fluciclovine F18, PET/CT)	Fluciclovine F18	Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

Primary Outcome Measures

Name	Time	Method
Mean Standardized Uptake Value (SUVmean) by Lesion Type	Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy	Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Maximum Standardized Uptake Value (SUVmax) by Lesion Type	Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy	Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

Secondary Outcome Measures