Prostate CancerPhase 2NCT01304485
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
A Phase 2 study testing Sodium Acetate C11 in people with Prostate Cancer, run by Phoenix Molecular Imaging at 1 site in United States.
Trial summary
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy 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?
- Sodium Acetate C11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2019
- Phase
- Phase 2
- 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
- recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)
Who cannot join
- < 18 years old
- claustrophobic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
Read the detailed description
The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.
Specific questions to be addressed:
- What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
- How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
- What is the optimal imaging protocol in terms of imaging time after injection?
- Conditions
- Prostate Cancer
- Being tested
- Sodium Acetate C11
- Keywords
- Recurrent Prostate Carcinoma, sodium acetate c11, PET, prostate cancer, rising PSA, PSA recurrence, biochemical recurrence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Acetate C11Drug
Also called Carbon 11 Acetate PET, C11 Acetate, AC-PET
PET Imaging with Sodium Acetate C11
| Study group | Role | What they receive |
|---|---|---|
| Sodium Acetate C11 PET Imaging | Experimental | Not described Receives: Drug: Sodium Acetate C11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV (Standardized Uptake Value)
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
Measured: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Secondary outcomes (1)
PSA (prostate specific antigen)
PSA will be monitored per routine clinical follow-up.
Measured: Every 3 - 6 months for 24 months after PET imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2019
- Study completionJan 2019
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.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Molecular Imaging
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Almeida MD, Phoenix Molecular Imaging
- Investigators
- Fabio Almeida, M.D., Principal investigator, Medical Director, Phoenix Molecular Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304485
- Sponsor's protocol ID
- AMIC-AC-001
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2011
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Journal Publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
- ClinicalTrials.gov ID
- NCT01304485
- Acronym / sponsor ID
- AMIC-AC-001
- Conditions
- Prostate Cancer
- Keywords
- Recurrent Prostate Carcinoma, sodium acetate c11, PET, prostate cancer, rising PSA, PSA recurrence, biochemical recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Phoenix Molecular ImagingUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Feb 2011 (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.
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
Detailed description
The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.
Specific questions to be addressed:
- What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
- How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
- What is the optimal imaging protocol in terms of imaging time after injection?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Acetate C11 PET Imaging | Experimental | Drug: Sodium Acetate C11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)
Key exclusion criteria (2 listed)
- < 18 years old
- claustrophobic patients
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 |
|---|---|---|
| Sodium Acetate C11Also: Carbon 11 Acetate PET, C11 Acetate, AC-PETPET Imaging with Sodium Acetate C11 | Drug | Sodium Acetate C11 PET Imaging |
Primary outcome
SUV (Standardized Uptake Value)
Time frame: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
1 secondary outcome
PSA (prostate specific antigen)
Time frame: Every 3 - 6 months for 24 months after PET imaging
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 7 Mar 2019.
- Individual participant dataSharing planned: Yes. Journal Publication
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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.
Fabio Almeida, M.D. principal investigator
Medical Director, Phoenix Molecular Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Acetate C11 in people with Prostate Cancer, run by Phoenix Molecular Imaging 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 1 inclusion and 2 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 7 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
SUV (Standardized Uptake Value) (time frame: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration). 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 7 Mar 2019.