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Malignant Neoplasm of ProstateNCT04765423

Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease

A study testing [F-18] NaF PET/CT and [F-18] fluciclovine PET/CT in people with Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Malignant Neoplasm of Prostate
What is being tested?
[F-18] NaF PET/CT and [F-18] fluciclovine PET/CT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
25 Mar 2021to 18 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
  • Must understand and voluntarily sign an Informed Consent Document

Who cannot join

  • -Cannot tolerate imaging up to 60 minutes of total imaging

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: [F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

Read the detailed description

The study will assess the diagnostic performance of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT as the reference standard. Each bone lesion identified on [F-18] NaF PET/CT will be compared with the level of [F-18] fluciclovine uptake

The primary objective is to assess [F-18] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with [F-18] NaF as a the reference standard.

Being tested
[F-18] NaF PET/CT, [F-18] fluciclovine PET/CT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [F-18] NaF PET/CTDevice

    Radiotracer F-18 NaF used on the PET/CT imaging

  • [F-18] fluciclovine PET/CTDevice

    Also called Axumin

    F-18 fluciclovine (Axumin ®) used on the PET/CT camera

Study groups in NCT04765423
Study groupRoleWhat they receive
NaF PET/CT scan and F-18 fluciclovine PET/CTExperimentalVisit 1: Participant receives a whole body [F-18] NaF PET/CT (diagnostic study) Visit 2: Participant receives a whole body [F-18] fluciclovine PET/CT within 3 weeks of Visit 1
Receives: Device: [F-18] NaF PET/CT; Device: [F-18] fluciclovine PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT

    Agreement of imaging methods as measured by number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT broken down by diagnostic score on a lesion-by-lesion basis (1 to 5)

    1. Definitely benign
    2. Probably benign
    3. Equivocal
    4. Probably malignant
    5. Definitely malignant

    Measured: At time of scan, up to 60 minutes per scan

  2. Sensitivity

    Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via sensitivity

    Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):

    Sensitivity = TP / (TP+FN)

    Measured: At time of scan, up to 60 minutes per scan

  3. Specificity

    Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via specificity

    Specificity is the number of true Negatives (TN) divided by the sum of TN and false positives (FP):

    Sensitivity = TN / (TN+FP)

    Measured: At time of scan, up to 60 minutes per scan

  4. Positive Predictive Value (PPV)

    Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via PPV

    PPV is the number of true TP divided by the sum of TP and FP:

    Sensitivity = TP / (TP+FP)

    Measured: At time of scan, up to 60 minutes per scan

  5. Negative Predictive Value (NPV)

    Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via NPV

    NPV is the number of true TN divided by the sum of TN and FN:

    Sensitivity = TN / (TN+FN)

    Measured: At time of scan, up to 60 minutes per scan

  6. Area under the curve (AUC)

    Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves

    Measured: At time of scan, up to 60 minutes per scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start25 Mar 2021
  3. Primary completion18 Mar 2022
  4. Study completion18 Mar 2022

Why it stopped: Poor patient accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765423
Sponsor's protocol ID
CASE11820
Status last verified
Mar 2022
First submitted
18 Feb 2021
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No current plans to share IPD

Questions about this trial

What is this clinical trial studying?

A study testing [F-18] NaF PET/CT and [F-18] fluciclovine PET/CT in people with Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT (time frame: At time of scan, up to 60 minutes per scan). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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