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

NCT04134208 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2019-0030NCI-2019-06047
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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. An analysis of the quantitative data was recently performed for the 2 participants.

  Up to 2 years

Secondary Outcomes (5)

• 18F-fluciclovine PET Imaging Response - SUVMax

  Up to 2 years

• 18F-fluciclovine PET Imaging Response - SUVMean

  Up to 2 years

• 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume

  Up to 2 years

• Sites of Progressive Disease Development

  Up to 2 years

• Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)

  Up to 2 years

Study Arms (1)

Diagnostic (fluciclovine F18, PET-CT)

EXPERIMENTAL

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; Drug: Fluciclovine F18; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET-CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Diagnostic (fluciclovine F18, PET-CT)

Fluciclovine F18 DRUG

Given IV

Also known as: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18

Diagnostic (fluciclovine F18, PET-CT)

Positron Emission Tomography PROCEDURE

Undergo PET-CT scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (fluciclovine F18, PET-CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known brain metastasis
• Small cell carcinoma of the prostate

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Gregory Ravizzini
• Organization: The University of Texas M D Anderson Cancer Center

gravizzini@mdanderson.org

(713) 518-9866

Study Officials

• Gregory C Ravizzini

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: September 19, 2019
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Locations

US (1)