Prostate CancerNCT02462447
Carbon-11 Labeled Sarcosine in Prostate Cancer
An observational study of Prostate Cancer, run by University of Michigan at 1 site in United States.
Trial summary
Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 11C-sarcosine and 11C-choline
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 8 Feb 2017
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Subjects with confirmed or suspected prostate cancer who will undergo a planned tissue biopsy of the known or suspected tumor Group 2: Healthy volunteers.
Who may be able to join
- Males 40 years of age or older
- Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)
Who cannot join
- Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
- Body weight > 350 lbs (158 kg)
- Prisoners
- Subject not willing or able to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
About this study
Official title: Biodistribution and Mechanism of Action of the 11C-labeled PET Tracer Sarcosine in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics and Biodistribution in Healthy Volunteers
Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.
Read the detailed description
Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.
- Conditions
- Prostate Cancer
- Being tested
- 11C-sarcosine, 11C-choline
- Keywords
- prostate, cancer, biopsy, PET
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-sarcosineDrug
Radiotracer injection for PET/CT scan
11C-cholineDrug
Radiotracer injection for PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each. Receives: Drug: 11C-sarcosine; Drug: 11C-choline | |
| Healthy Volunteer | Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes. Receives: Drug: 11C-sarcosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
Measured: One Month
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
Measured: One Month
Secondary outcomes (3)
Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline
Standardized uptake (SUV) values from tumor tissues relative to background, also called tumor-to-background ratios (TBR), will be determined from both, 11C-sarcosine and 11C-choline. Then TBR measurements from 11C-choline and 11C-sarcosine will be compared to identify whether 11C-sarcosine improves tumor to background image contrast relative to 11C-choline in prostate cancer.
Measured: One Month
Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials
Measured: One Month
Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Morand Piert, MD, University of Michigan
- Investigators
- Morand R Piert, MD, Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462447
- Sponsor's protocol ID
- HUM00091201
- Other IDs
- R21CA191052-01
- Status last verified
- Nov 2017
- First submitted
- 27 Feb 2015
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Piert M, Shao X, Raffel D, Davenport MS, Montgomery J, Kunju LP, Hockley BG, Siddiqui J, Scott PJH, Chinnaiyan AM, Rajendiran T. Preclinical Evaluation of 11C-Sarcosine as a Substrate of Proton-Coupled Amino Acid Transporters and First Human Application in Prostate Cancer. J Nucl Med. 2017 Aug;58(8):1216-1223. doi: 10.2967/jnumed.116.173179. Epub 2017 Mar 16.
PubMed 28302759
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution and Mechanism of Action of the 11C-labeled PET Tracer Sarcosine in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics and Biodistribution in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02462447
- Acronym / sponsor ID
- HUM00091201
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, biopsy, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2015
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 4 Jun 2015 (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.
Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.
Detailed description
Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | Drug: 11C-sarcosine, Drug: 11C-cholineSubjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each. |
| Healthy Volunteer | – | Drug: 11C-sarcosineSubjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Subjects with confirmed or suspected prostate cancer who will undergo a planned tissue biopsy of the known or suspected tumor Group 2: Healthy volunteers.
Key inclusion criteria (2 listed)
- Males 40 years of age or older
- Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)
Key exclusion criteria (4 listed)
- Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
- Body weight > 350 lbs (158 kg)
- Prisoners
- Subject not willing or able to sign informed consent
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-sarcosineRadiotracer injection for PET/CT scan | Drug | Healthy Volunteer, Prostate Cancer |
| 11C-cholineRadiotracer injection for PET/CT scan | Drug | Prostate Cancer |
Primary outcome
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
Time frame: One Month
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
Time frame: One Month
3 secondary outcomes
Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline
Time frame: One Month
Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials
Time frame: One Month
Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures
Time frame: One Month
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 9 Nov 2017.
- Results publication: PubMed 28302759Piert M, Shao X, Raffel D, Davenport MS, Montgomery J, Kunju LP, Hockley BG, Siddiqui J, Scott PJH, Chinnaiyan AM, Rajendiran T. Preclinical Evaluation of 11C-Sarcosine as a Substrate of Proton-Coupled Amino Acid Transporters and First Human Application in Prostate Cancer. J Nucl Med. 2017 Aug;58(8):1216-1223. doi: 10.2967/jnumed.116.173179. Epub 2017 Mar 16.
- 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.
Morand R Piert, MD principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Michigan 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 2 inclusion and 4 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 9 Nov 2017. 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.
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?
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients (time frame: One Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462447, which also lists 1 linked publication.
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 9 Nov 2017.