Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

NCT03707184 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HCI113970NCI-2018-02083
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

Conditions

Metastatic Prostate Carcinoma; Prostate Carcinoma Metastatic in the Bone; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Mean Standardized Uptake Value (SUVmean) by Lesion Type

  Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

  Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

• Maximum Standardized Uptake Value (SUVmax) by Lesion Type

  Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

  Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

Study Arms (1)

Diagnostic (fluciclovine F18, PET/CT)

EXPERIMENTAL

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

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 (CAT), computerized tomography, CT, CT Scan, tomography

Diagnostic (fluciclovine F18, PET/CT)

Fluciclovine F18 DRUG

Given IV

Also known as: (18F)Fluciclovine, 18F-Fluciclovine, Fluciclovine (18F)

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

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
• Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
• All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

You may not qualify if:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
• Patients who require monitored anesthesia for PET scanning.
• Patients who are too claustrophobic to undergo PET scanning.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

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: Sam Mitchell
• Organization: Huntsman Cancer Institute, Center for Quantitative Cancer Imaging

sam.mitchell@hci.utah.edu

8012136110

Study Officials

• Jeffrey Yap, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 16, 2018
• Study Start: October 2, 2018
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Locations

US (1)