Prostate Cancer PatientsEarly Phase 1NCT02715583
C-Acetate PET/CT Imaging to Evaluate Treatment Changes in Prostate Cancer
A Early Phase 1 study testing 11C-Acetate in people with Prostate Cancer Patients, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients
- What is being tested?
- 11C-Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 25 Sep 2020
- Phase
- Early Phase 1
- 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
- History of biopsy proven or clinically documented castrate resistant prostate cancer which is metastatic to bone as assessed by medical record review.
- Patients selected for Ra-223 dichloride therapy for treatment of bone metastasis by their treating physician.
- Participants must 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 procedures.
Who cannot join
- Not on current androgen deprivation therapy or plan for withdrawal of androgen deprivation therapy
- Cytotoxic chemotherapy within 4 weeks prior to study enrollment
- Systemic radioisotope therapy within 24 weeks prior to study enrollment
- Eminent or established cord compression as assessed by medical record review
- History of hemibody external radiotherapy as assessed by medical record review
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Show all 9Show fewer
- Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Documented visceral metastases or current lymphadenopathy > 3 cm by standard imaging (e.g. MRI, CT, ultrasound, FDG PET/CT)
- Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Women, children, fetuses, neonates, or prisoners are not included in this research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19004
About this study
Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy
Read the detailed description
Our proposed study aims to use 11C-acetate PET/CT for evaluation of treatment response to Ra-223 dichrolide therapy. 11C-acetate has been shown to have superior detection of osseous and non-osseous metastatic lesions as compared to 18F-FDG PET/CT and 99Tc-MDP imaging. 11C-acetate is generally >80% sensitive for detection of metastatic lesions as compared to less than 70% for 18F-FDG PET/CT with higher tumor than tumor to background ratio14-19. The majority of interest in 11C-acetate PET/CT imaging is focused on the detection of distant metastatic disease in patients with biochemical relapse status post definitive local therapy18,20,21. In patients with 99Tc-MDP detected prostate bone metastases, Yu et al. have found that 11C-acetate PET/CT was superior to 18F-FDG PET/CT for evaluation of bone metastases treatment response regardless of hormonal or taxol based chemotherapy. In the Yu et al. pilot study, 11C-acetate PET/CT findings correlated with composite clinical designation of treatment response in 100% of patients22.
Our study will evaluate baseline standard uptake value (SUVmax) and change in SUVmax of 11C-acetate PET/CT at approximately 10 weeks weeks (+/- 3 weeks) , generally after two cycles of Ra-223 dichloride therapy. SUVmax will be recorded for a selected index lesion and an average of the 5 most 11C-acetate avid lesions, from the baseline scan. Evaluation of 11C-acetate uptake changes to therapy in this pilot study will allow sample size calculation for future trials correlating 11C-acetate changes to therapy to TTP, OS and symptomatic relief end points.
- Conditions
- Prostate Cancer Patients
- Being tested
- 11C-Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-AcetateDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease. | Experimental | Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania.
Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy
Patients will also undergo serial lab tests (PSA, and alkaline phosphatase levels). If these tests are done as part of clinical standard of care they will not need to be repeated for this study. Patients will be asked to complete a quality of life metric (short form of the McGill pain questionnaire) on the day of each PET/CT scan. Receives: Drug: 11C-Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the fold change in SUVmax ()
- Estimate the fold change in SUVmax () of selected index lesions and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, measured at pre and post Ra-223 dichrolide therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Pryma, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715583
- Sponsor's protocol ID
- UPCC 02816
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Acetate PET/CT Imaging to Evaluate Treatment Changes in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02715583
- Acronym / sponsor ID
- UPCC 02816
- Conditions
- Prostate Cancer Patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 22 Mar 2016 (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.
Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy
Detailed description
Our proposed study aims to use 11C-acetate PET/CT for evaluation of treatment response to Ra-223 dichrolide therapy. 11C-acetate has been shown to have superior detection of osseous and non-osseous metastatic lesions as compared to 18F-FDG PET/CT and 99Tc-MDP imaging. 11C-acetate is generally >80% sensitive for detection of metastatic lesions as compared to less than 70% for 18F-FDG PET/CT with higher tumor than tumor to background ratio14-19. The majority of interest in 11C-acetate PET/CT imaging is focused on the detection of distant metastatic disease in patients with biochemical relapse status post definitive local therapy18,20,21. In patients with 99Tc-MDP detected prostate bone metastases, Yu et al. have found that 11C-acetate PET/CT was superior to 18F-FDG PET/CT for evaluation of bone metastases treatment response regardless of hormonal or taxol based chemotherapy. In the Yu et al. pilot study, 11C-acetate PET/CT findings correlated with composite clinical designation of treatment response in 100% of patients22.
Our study will evaluate baseline standard uptake value (SUVmax) and change in SUVmax of 11C-acetate PET/CT at approximately 10 weeks weeks (+/- 3 weeks) , generally after two cycles of Ra-223 dichloride therapy. SUVmax will be recorded for a selected index lesion and an average of the 5 most 11C-acetate avid lesions, from the baseline scan. Evaluation of 11C-acetate uptake changes to therapy in this pilot study will allow sample size calculation for future trials correlating 11C-acetate changes to therapy to TTP, OS and symptomatic relief end points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease. | Experimental | Drug: 11C-AcetatePatients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy Patients will also undergo serial lab tests (PSA, and alkaline phosphatase levels). If these tests are done as part of clinical standard of care they will not need to be repeated for this study. Patients will be asked to complete a quality of life metric (short form of the McGill pain questionnaire) on the day of each PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of biopsy proven or clinically documented castrate resistant prostate cancer which is metastatic to bone as assessed by medical record review.
- Patients selected for Ra-223 dichloride therapy for treatment of bone metastasis by their treating physician.
- Participants must 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 procedures.
Key exclusion criteria (9 listed)
- Not on current androgen deprivation therapy or plan for withdrawal of androgen deprivation therapy
- Cytotoxic chemotherapy within 4 weeks prior to study enrollment
- Systemic radioisotope therapy within 24 weeks prior to study enrollment
- Eminent or established cord compression as assessed by medical record review
- History of hemibody external radiotherapy as assessed by medical record review
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 |
|---|---|---|
| 11C-Acetate | Drug | Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease. |
Primary outcome
Estimate the fold change in SUVmax ()
Time frame: 1 year
• Estimate the fold change in SUVmax () of selected index lesions and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, measured at pre and post Ra-223 dichrolide therapy.
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 18 May 2022.
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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.
Dan Pryma, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 11C-Acetate in people with Prostate Cancer Patients, run by Abramson Cancer Center at Penn Medicine 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 3 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: finished, as of the sponsor's last update on 18 May 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Estimate the fold change in SUVmax () (time frame: 1 year). 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 18 May 2022.