Metastatic CancerNCT00392938
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
An observational study of Metastatic Cancer and Prostate Cancer, run by University of Washington at 2 sites in United States.
Trial summary
RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Metastatic Cancer, Prostate Cancer
- What is being tested?
- antiandrogen therapy, docetaxel and C-11 acetate PET scan
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to May 2010
- Phase
- Observational
- 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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer, meeting 1 of the following criteria:
- Metastatic hormone-sensitive disease prior to initiation of first-line androgen-deprivation therapy and meets the following criteria:
- Histologic confirmation of original diagnosis
- Hormone-sensitive is defined as progressive disease in the absence of androgen-deprivation therapy
- Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
- Metastatic hormone-refractory disease prior to initiation of a first-line chemotherapy regimen that includes docetaxel and meets the following criteria:
- Histologic confirmation of original diagnosis
- Hormone-refractory is defined as development or advancement of metastatic disease with castrate testosterone levels (total testosterone < 20 ng/dL)
- Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
- Must have castrate testosterone levels (< 20 ng/dL) from orchiectomy or undergoing maintenance with a luteinizing hormone-releasing hormone agonist
- Outside the window of a potential antiandrogen withdrawal response (either decline in prostate-specific antigen or objective response by imaging)
PATIENT CHARACTERISTICS:
- Life expectancy > 12 weeks
- No serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and undergo imaging studies
- No condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
- Able to lie still for the imaging
- Weight ≤ 300 lbs
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior bicalutamide or nilutamide
- At least 4 weeks since prior flutamide, ketoconazole, diethylstilbestrol, or estradiol
- More than 4 weeks since prior bisphosphonate therapy
- More than 4 weeks since prior radiotherapy to the bone
- More than 4 weeks since prior radiopharmaceutical treatment to the bone
- No concurrent radiotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
University of Washington School of Medicine
Seattle, Washington, 98195
About this study
Official title: Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.
Read the detailed description
OBJECTIVES:
Primary
- Correlate pre-treatment and 3-month post-treatment carbon-11 (^11C) acetate and fludeoxyglucose F 18 positron emission tomography (^18F-FDG PET) images with changes in clinical response measures in patients with bone-dominant metastatic prostate cancer.
Secondary
- Compare ^11C acetate and ^18F-FDG PET scanning results with bone scintigraphy in these patients to determine which best predicts clinical response.
- Correlate changes in ^11C acetate and ^18F-FDG PET with changes in prostate-specific antigen level.
- Correlate changes in ^11C acetate and ^18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales).
- Correlate ^11C acetate and ^18F-FDG PET scan response with clinical time to progression.
- Determine if PET scan response can predict duration of progression-free survival.
OUTLINE: This is a pilot study. Patients are stratified according to hormone response (sensitive [stratum 1] vs refractory [stratum 2]).
Patients undergo carbon-11 acetate and fludeoxyglucose F 18 positron emission tomography imaging prior to and 3 months after initiation of either androgen-deprivation therapy (stratum 1) or docetaxel (stratum 2).
Pain and quality of life are assessed at baseline and at 3 months.
Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Metastatic Cancer, Prostate Cancer
- Being tested
- antiandrogen therapy, docetaxel, C-11 acetate PET scan, F-18 FDG PET scan, Tc-99m bone scan
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, bone metastases
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiandrogen therapyDrug
docetaxelDrug
C-11 acetate PET scanDiagnostic test
F-18 FDG PET scanDiagnostic test
Tc-99m bone scanDiagnostic test
CT scan of the chest, abdomen and pelvisDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures
Secondary outcomes (5)
Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
PET scan response as a predictor of duration of progression-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Evan Y. Yu, MD, University of Washington
- Investigators
- Evan Y. Yu, MD, Study chair, Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392938
- Sponsor's protocol ID
- 6129
- Other IDs
- P30CA015704, UWCC-6129, UWCC-06-0500-H/A, FHCRC-6129, CDR0000480347
- Status last verified
- Mar 2017
- First submitted
- 25 Oct 2006
- Last updated
- 13 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
- ClinicalTrials.gov ID
- NCT00392938
- Acronym / sponsor ID
- 6129
- Conditions
- Metastatic Cancer, Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, bone metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- May 2010 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.
Detailed description
OBJECTIVES:
Primary
- Correlate pre-treatment and 3-month post-treatment carbon-11 (^11C) acetate and fludeoxyglucose F 18 positron emission tomography (^18F-FDG PET) images with changes in clinical response measures in patients with bone-dominant metastatic prostate cancer.
Secondary
- Compare ^11C acetate and ^18F-FDG PET scanning results with bone scintigraphy in these patients to determine which best predicts clinical response.
- Correlate changes in ^11C acetate and ^18F-FDG PET with changes in prostate-specific antigen level.
- Correlate changes in ^11C acetate and ^18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales).
- Correlate ^11C acetate and ^18F-FDG PET scan response with clinical time to progression.
- Determine if PET scan response can predict duration of progression-free survival.
OUTLINE: This is a pilot study. Patients are stratified according to hormone response (sensitive [stratum 1] vs refractory [stratum 2]).
Patients undergo carbon-11 acetate and fludeoxyglucose F 18 positron emission tomography imaging prior to and 3 months after initiation of either androgen-deprivation therapy (stratum 1) or docetaxel (stratum 2).
Pain and quality of life are assessed at baseline and at 3 months.
Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiandrogen therapy | Drug | – |
| docetaxel | Drug | – |
| C-11 acetate PET scan | Diagnostic test | – |
| F-18 FDG PET scan | Diagnostic test | – |
| Tc-99m bone scan | Diagnostic test | – |
| CT scan of the chest, abdomen and pelvis | Diagnostic test | – |
Primary outcome
Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures
5 secondary outcomes
Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
PET scan response as a predictor of duration of progression-free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Y. Yu, MD study chair
Seattle Cancer Care Alliance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Prostate Cancer, run by University of Washington at 2 sites 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?
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: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.