AzTrials
AzTrials

Hormone-resistant Prostate CancerNCT02169063

Carbon-11 Acetate and Fluorine F 18 Sodium Fluoride PET as a Biomarker of Treatment Response in Patients With Hormone Resistant Metastatic Prostate Cancer

A study testing carbon-11 acetate, fluorine F 18 sodium fluoride and positron emission tomography in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by University of Washington at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron emission tomography (PET) as a biomarker of treatment response in patients with prostate cancer that does not respond to treatment with hormones and has spread to other parts of the body. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
carbon-11 acetate, fluorine F 18 sodium fluoride and positron emission tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Nov 2018
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

  • Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
  • At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dL) while on continuous androgen deprivation therapy
  • Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
  • Be willing and able to comply with scheduled visits and other trial procedures
  • Presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (CT) scan appearance (magnetic resonance imaging [MRI] if indicated), or plain x-ray appearance

Who cannot join

  • Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
  • A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
  • Expected lifespan of 12 weeks or less
  • Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
  • Radiation treatment to bone less than 4 weeks from the first PET scan
  • Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
Show all 9Show fewer
  • Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
  • Inability to lie still for imaging
  • Weight > 300 pounds (lbs)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer

This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron emission tomography (PET) as a biomarker of treatment response in patients with prostate cancer that does not respond to treatment with hormones and has spread to other parts of the body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be useful in evaluating prostate cancer activity in response to treatment. Comparing results of diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done before and after therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Demonstrate that carbon-11 acetate (11C-acetate) and 18F-fluoride (fluorine F 18 sodium fluoride) PET scans change as a result of treatment for men with metastatic castration-resistant prostate cancer by comparison of pre-treatment and 6-12 week post-treatment images (standardized uptake value [SUV], influx constant [Ki], and rate constant [K1]) with clinical response measures.

SECONDARY OBJECTIVES:

  1. Compare results from 11C-acetate and 18F-fluoride PET scanning with the patient's clinical bone scan and determine which predicts clinical response better.

II. Compare changes in 11C-acetate and 18F-fluoride PET with changes in prostate-specific antigen (PSA) level.

III. Compare changes in 11C-acetate and 18F-fluoride PET with changes in urinary N-telopeptide and bone alkaline phosphatase.

IV. Determine if either baseline uptake or change in uptake for 11C-acetate and/or 18F-fluoride PET is correlated with progression-free survival by Prostate Cancer Working Group 2 (PCWG2) criteria (Scher, 2008).

  1. Determine if either baseline uptake or change in uptake by 11C-acetate and/or 18F-fluoride PET is correlated with skeletal-related events (SREs) defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia.

VI. Percentage of patients that experience adverse events by Common Terminology Criteria for Adverse Events, version 4.0.

VII. For patients who have tissue/blood biomarkers obtained for other indications, directly compare baseline uptake and change in uptake by 11C-acetate and/or 18F-fluoride PET with those biomarkers.

OUTLINE:

Patients receive carbon-11 acetate intravenously (IV) and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.

After completion of treatment, patients are followed up every 3 months for up to 5 years.

Being tested
carbon-11 acetate, fluorine F 18 sodium fluoride, positron emission tomography, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • carbon-11 acetateRadiation

    Given IV

  • fluorine F 18 sodium fluorideRadiation

    Also called 18 F-NaF, F-18 NaF

    Given IV

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Undergo 11C-acetate and 18F-fluoride PET

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02169063
Study groupRoleWhat they receive
Diagnostic (11C-acetate, 18F-fluoride, PET)ExperimentalPatients receive carbon-11 acetate IV and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.
Receives: Radiation: carbon-11 acetate; Radiation: fluorine F 18 sodium fluoride; Procedure: positron emission tomography; Other: laboratory biomarker analysis

What is being measured

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

  1. Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy

    Percentage change between pre-treatment and post-therapy measurements will be computed for PET measures. Log transformations will be considered if the rates of change are highly skewed. Additionally, changes in PET measures will be analyzed descriptively by a stem-and-leaf plot.

    Measured: Baseline to up to 12 weeks

Secondary outcomes (7)

  1. Clinical response data (response, stable disease or progression)

    Molecular imaging measures and clinical measures of treatment response, percentage change in PET derived imaging data will be compared to standard clinical parameters. Association between these two types of data decline will be analyzed using the mid-P adjustment to Fisher's exact test (Lancaster, 1961) to evaluate the potential clinical utility of change in 11C-acetate and 18F-fluoride as a biomarker for response.

    Measured: Up to 5 years

  2. Proportion of both 11C-acetate and 18F-fluoride PET scans and 99mTc bone scans in discovering suspicious sites that are later confirmed by standard bone scans

    Statistical significance of two proportions will be tested with a two-sample t-test for proportions (or nonparametric alternative).

    Measured: Up to 5 years

  3. Change in PSA parameters

    Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in PSA.

    Measured: Baseline to up to 30 days post-PET

  4. Change in urinary N-telopeptide

    Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in urinary N-telopeptide.

    Measured: Baseline to up to 30 days post-PET

  5. Change in bone alkaline phosphatase

    Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in bone alkaline phosphatase.

    Measured: Baseline to up to 30 days post-PET

  6. Progression-free survival (PFS) using PCWG2

    Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on PCWG2 PFS.

    Measured: Up to 5 years

  7. SRE defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia

    Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on time of first SRE.

    Measured: Up to 5 years

Timeline

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

  1. First posted20 Jun 2014 (estimated)
  2. Study startDec 2015
  3. Primary completionNov 2018 (estimated)

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
NCT02169063
Sponsor's protocol ID
8021
Other IDs
NCI-2014-01203, 8021, P30CA015704
Status last verified
Aug 2016
First submitted
18 Jun 2014
Last updated
31 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing carbon-11 acetate, fluorine F 18 sodium fluoride and positron emission tomography in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by University of Washington 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 5 inclusion and 9 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 31 Aug 2016. 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?

Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy (time frame: Baseline to up to 12 weeks). 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 NCT02169063.

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 31 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in