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

Study Overview
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Brief Summary
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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
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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.

Official Title
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[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

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

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: Fluciclovine F18
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluciclovine F18, PET/CT)<br>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. | Procedure: Computed Tomography<br>* Undergo PET/CT scan<br>* Other names: tomography;Drug: Fluciclovine F18<br>* Given IV<br>* Other names: Fluciclovine (18F);Procedure: Positron Emission Tomography<br>* Undergo PET/CT scan<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean standardized uptake value (SUVmean) | The primary analysis of SUVmean will be t-tests comparing the osteoblastic and osteolytic lesions. An additional analysis of the primary objective will be one way analysis of variance (ANOVA) with Tukey's post hoc analysis comparing all four lesion types (osteoblastic, osteolytic, marrow and mixed). As a secondary sensitivity analysis mixed effects models with a fixed effect for lesion type and a random patient effect will also be fit. | Up to 2 years | 
| Maximum standardized uptake value (SUVmax) | The primary analysis of SUVmax will be t-tests comparing the osteoblastic and osteolytic lesions. An additional analysis of the primary objective will be one way analysis of variance (ANOVA) with Tukey's post hoc analysis comparing all four lesion types (osteoblastic, osteolytic, marrow and mixed). As a secondary sensitivity analysis mixed effects models with a fixed effect for lesion type and a random patient effect will also be fit. | Up to 2 years | 
| Lesion uptake of 18F fluciclovine | Spearman correlation of lesion uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and 18F fluciclovine-positron emission tomography/computed tomography (PET/CT) at baseline and after 3 and 6 cycles of radium 223 will be calculated. The number of lesions identified by 99mTc-MDP bone scintigraphy alone, 18F fluciclovine- PET/CT alone, and both 99mTc-MDP bone scintigraphy and 18F fluciclovine- PET/CT will be tabulated. | Up to 6 months | 
| Time to biochemical failure | Will be analyzed using standard survival analysis methods. Two binary variables will be constructed, by dividing the cohort into those that did and did not achieve a 25% or greater reduction in average (ave)SUVmax or ave SUVmean on 18F fluciclovine-PET/CT imaging after completion of all radiation therapy. Kaplan-Meier methods will be used for plotting and log rank tests will be used to determine whether either of these binary variable is predictive of increased time to biochemical failure. | Up to 2 years |