Prostate CancerPhase 2NCT01530269
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
A Phase 2 study testing C11-Sodium Acetate in people with Prostate Cancer and Prostate Adenocarcinoma, run by Phoenix Molecular Imaging at 1 site in United States.
Trial summary
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- C11-Sodium Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients will be studied who have prostate cancer:
- Diagnosed with prostate adenocarcinoma
- Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
- Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:
- Gleason score >= 7 or PSA >= 10
- Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
- Rising or non-responding PSA
Who cannot join
- < 18 years old
- claustrophobic patients
Trial locations and contacts
1 site in 1 country.
About this study
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
Read the detailed description
OBJECTIVES:
- Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
- Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- C11-Sodium Acetate
- Keywords
- intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy, chemotherapy, hormone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C11-Sodium AcetateDrug
Also called C11 Acetate PET, Carbon 11, AC-PET
PET Imaging with C11-Sodium Acetate
| Study group | Role | What they receive |
|---|---|---|
| PET/CT imaging with C11-Sodium Acetate | Experimental | Not described Receives: Drug: C11-Sodium Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Biopsy of metastatic site(s)
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
Measured: Assessed within 30 days following AC-PET
Secondary outcomes (1)
PSA (prostate specific antigen)
PSA (prostate specific antigen) will be monitored per routine clinical follow-up
Measured: Each 3 - 6 months for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startApr 2012
- 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
- 300 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, MD, Principal investigator, Medical Director, Phoenix Molecular Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530269
- Sponsor's protocol ID
- AMIC-AC-002
- Status last verified
- Mar 2019
- First submitted
- 4 Feb 2012
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01530269
- Acronym / sponsor ID
- AMIC-AC-002
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Phoenix Molecular ImagingUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 Feb 2012 (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 using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
Detailed description
OBJECTIVES:
- Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
- Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT imaging with C11-Sodium Acetate | Experimental | Drug: C11-Sodium Acetate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with prostate adenocarcinoma
- Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
- Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:
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 |
|---|---|---|
| C11-Sodium AcetateAlso: C11 Acetate PET, Carbon 11, AC-PETPET Imaging with C11-Sodium Acetate | Drug | PET/CT imaging with C11-Sodium Acetate |
Primary outcome
Tissue Biopsy of metastatic site(s)
Time frame: Assessed within 30 days following AC-PET
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
1 secondary outcome
PSA (prostate specific antigen)
Time frame: Each 3 - 6 months for 24 months
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: No
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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, MD 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 C11-Sodium Acetate in people with Prostate Cancer and Prostate Adenocarcinoma, 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 7 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?
Tissue Biopsy of metastatic site(s) (time frame: Assessed within 30 days following AC-PET). 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.