NCT04134208

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET-CT scan
DRUG	Fluciclovine F18	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET-CT scan

Timeline

• Start date: 2019-09-19
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2019-10-22
• Last updated: 2025-01-16
• Results posted: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study