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

Phase 4

Terminated

Conditions: Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8

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

Registration Number: NCT04134208

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluciclovine F18, PET-CT)	Computed Tomography	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.
Diagnostic (fluciclovine F18, PET-CT)	Positron Emission Tomography	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.
Diagnostic (fluciclovine F18, PET-CT)	Fluciclovine F18	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.

Primary Outcome Measures

Name	Time	Method
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"	Up to 2 years	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. An analysis of the quantitative data was recently performed for the 2 participants.

Secondary Outcome Measures

Name	Time	Method
18F-fluciclovine PET Imaging Response - SUVMax	Up to 2 years	Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
18F-fluciclovine PET Imaging Response - SUVMean	Up to 2 years	Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. SUVmean represents the average SUV value across a defined region of interest (ROI) in the tumor. The Measure Type is a number, that is dimensionless, because it is the average ratio of tissue activity concentration to the injected dose normalized by the patient's weight.
18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume	Up to 2 years	Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Sites of Progressive Disease Development	Up to 2 years	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.
Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)	Up to 2 years	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.