An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response. SECONDARY OBJECTIVES: I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement. II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 [PCWG2] criteria). III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response. OUTLINE: Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (IV) then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.

Official Title
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18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)

Conditions
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Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

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: Histologically or cytologically proven prostate carcinoma Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI) Castration naive disease, no prior systemic therapy for prostate cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Ability to understand and willingness to sign informed consent Exclusion Criteria: Known brain metastasis Small cell carcinoma of the prostate

Ages Eligible for Study
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Minimum Age: 18 Years

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>Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes. | Procedure: Computed Tomography<br>* Undergo PET-CT scan<br>* Other names: tomography;Drug: Fluciclovine F18<br>* Given IV<br>* Other names: GE-148 F-18;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 |
| --- | --- | --- |
| Metabolic response by fluciclovine F18 (18F-fluciclovine) positron emission tomography (PET) with standardized uptake values (SUV) | Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows ([pretreatment corrected SUVmax - posttreatment corrected SUVmax]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-fluciclovine PET imaging response | Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. | Up to 2 years | 
| Sites of progressive disease development | Will determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. | Up to 2 years | 
| Metabolic response by 18F-fluciclovine PET with target to blood pool ratio (TBR) | Will evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with TBR and correlate the findings with size changes as defined by conventional imaging and PSA response. | Up to 2 years |