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

November 22, 2024 updated by: University of Utah

[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Abnormal fluciclovine F18 ([18F] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

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.

After completion of diagnostic testing, patients are followed for 2 years.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (fluciclovine F18, PET/CT)
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
Undergo PET/CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • CT Scan
  • tomography
  • computerized tomography
  • Computerized Axial Tomography (CAT)
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Drug: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • 18F-Fluciclovine
  • Fluciclovine (18F)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Standardized Uptake Value (SUVmean) by Lesion Type
Time Frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
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
Time Frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Jeffrey Yap, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2018

Primary Completion (Actual)

February 3, 2022

Study Completion (Actual)

February 3, 2022

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI113970
  • NCI-2018-02083 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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