Prostate CancerNCT00139191
Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer
A study testing C-11 acetate PET scan in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- C-11 acetate PET scan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2005to May 2006
- 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
- Histologically documented prostate cancer
- Planned radical prostatectomy
- > 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
- Older than 18 years of age
Who cannot join
- Inability to lay on a scanner for 60 minutes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study Evaluating the Correlation Between Carbon 11 Acetate (C-11 Acetate) Uptake and Retention as Measured by Positron Emission Tomography (PET) and Fatty Acid Synthase (FAS) Expression in Prostate Cancer
The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).
Read the detailed description
- Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
- Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
- After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.
- Conditions
- Prostate Cancer
- Being tested
- C-11 acetate PET scan
- Keywords
- Prostate Cancer, positron emission tomography, carbon 11 acetate, PET, fatty acid synthase, FAS
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-11 acetate PET scanProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJul 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Robert Ross, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139191
- Sponsor's protocol ID
- 05-136
- Status last verified
- Oct 2009
- First submitted
- 29 Aug 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Correlation Between Carbon 11 Acetate (C-11 Acetate) Uptake and Retention as Measured by Positron Emission Tomography (PET) and Fatty Acid Synthase (FAS) Expression in Prostate Cancer
- ClinicalTrials.gov ID
- NCT00139191
- Acronym / sponsor ID
- 05-136
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, positron emission tomography, carbon 11 acetate, PET, fatty acid synthase, FAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Massachusetts General Hospital
- Study start
- Jul 2005
- Study completion
- May 2006 (actual)
- First posted
- 31 Aug 2005 (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.
The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).
Detailed description
- Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
- Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
- After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically documented prostate cancer
- Planned radical prostatectomy
- > 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
- Older than 18 years of age
Key exclusion criteria (1 listed)
- Inability to lay on a scanner for 60 minutes
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 |
|---|---|---|
| C-11 acetate PET scan | Procedure or surgery | – |
Primary outcome
To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.
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 2 Nov 2009.
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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.
Robert Ross, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-11 acetate PET scan in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 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?
The sponsor lists 4 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: finished, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.. 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 2 Nov 2009.