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Hormone-Resistant Prostate CancerPhase 1NCT02429804

NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 1 study testing Contrast-enhanced Magnetic Resonance Imaging, Fludeoxyglucose F-18 and Fluorine F 18 Sodium Fluoride in people with Hormone-Resistant Prostate Cancer and Metastatic Malignant Neoplasm in the Bone, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to… Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
Contrast-enhanced Magnetic Resonance Imaging, Fludeoxyglucose F-18 and Fluorine F 18 Sodium Fluoride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Apr 2015to 15 May 2017
Phase
Phase 1
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 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provides written informed consent
  • Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride)
  • Able to remain still for duration of the imaging procedure (about one hour)

Who cannot join

  • Metallic implants

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study

This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Estimate the performance of simultaneous NaF/FDG PET/MRI for the prediction of treatment response in patients with metastatic castrate resistant prostate cancer (mCRPC).

II. Estimate the performance of simultaneous NaF/FDG PET/MRI for detection of extra-skeletal disease progression during treatment in mCRPC patients.

OUTLINE:

Patients receive 18F NaF and 18F FDG intravenously (IV) over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.

After completion of study, patients are followed up for up to 12 months.

Being tested
Contrast-enhanced Magnetic Resonance Imaging, Fludeoxyglucose F-18, Fluorine F 18 Sodium Fluoride, Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI

    Undergo contrast-enhanced MRI

  • Fludeoxyglucose F-18Drug

    Also called 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18

    Given IV

  • Fluorine F 18 Sodium FluorideDrug

    Also called 18 F-NaF, F-18 NaF

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan

    Undergo PET/MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan

    Undergo PET/MRI

Study groups in NCT02429804
Study groupRoleWhat they receive
Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)ExperimentalPatients receive 18F NaF and 18F FDG IV over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.
Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Fludeoxyglucose F-18; Drug: Fluorine F 18 Sodium Fluoride; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

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

  1. Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity

    Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

    Measured: 24 weeks

  2. Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size

    Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

    Measured: 24 weeks

  3. Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis)

    Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.

    Measured: 24 weeks

  4. Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value

    Measured: 12 weeks

  5. Percent reduction at 12 weeks in MRI lesion size (per lesion analysis)

    Measured: 12 weeks

Secondary outcomes (2)

  1. Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis)

    Measured: Up to 24 weeks

  2. True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis)

    The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.

    Measured: 12 months

Timeline

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

  1. First posted29 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion15 May 2017
  4. Study completion15 May 2017

Why it stopped: Accrual factor

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 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02429804
Sponsor's protocol ID
PROS0063
Other IDs
NCI-2015-00553, ep 32653, 96754, PROS0063, P30CA124435
Status last verified
May 2017
First submitted
17 Apr 2015
Last updated
30 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Contrast-enhanced Magnetic Resonance Imaging, Fludeoxyglucose F-18 and Fluorine F 18 Sodium Fluoride in people with Hormone-Resistant Prostate Cancer and Metastatic Malignant Neoplasm in the Bone, run by Stanford University 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 3 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: stopped early, as of the sponsor's last update on 30 May 2017. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Accrual factor). Results are not available in the source record.

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?

Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity (time frame: 24 weeks). The study lists 5 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 NCT02429804.

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 30 May 2017.

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