Clinical trial NCT04134208: An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
Official title: 18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-22
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"
timeFrame: Up to 2 years
Secondary outcomes:
measure: 18F-fluciclovine PET Imaging Response - SUVMax
timeFrame: Up to 2 years
measure: 18F-fluciclovine PET Imaging Response - SUVMean
timeFrame: Up to 2 years
measure: 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume
timeFrame: Up to 2 years
measure: Sites of Progressive Disease Development
timeFrame: Up to 2 years
measure: Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gregory C Ravizzini
role: PRINCIPAL_INVESTIGATOR
References: