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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04134208
• Other study ID #: 2019-0030
• Secondary ID: NCI-2019-0604720
• Status: Terminated
• Phase: Phase 4
• Start date: September 19, 2019
• Est. completion date: June 28, 2022

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Prostate Carcinoma
• Prostatic Neoplasms
• Stage IVB Prostate Cancer AJCC v8

Intervention

Procedure:
• Computed Tomography
Undergo PET-CT scan

Drug:
• Fluciclovine F18
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET-CT scan

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   MD Anderson Cancer Center Website