Carbon-11 Labeled Sarcosine in Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 11C-sarcosine
* Drug: 11C-choline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer<br>Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each. | Drug: 11C-sarcosine<br>* Radiotracer injection for PET/CT scan<br>Drug: 11C-choline<br>* Radiotracer injection for PET/CT scan<br>|
| Healthy Volunteer<br>Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes. | Drug: 11C-sarcosine<br>* Radiotracer injection for PET/CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients |  | One Month | 
| Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers |  | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One Month | 
| Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials |  | One Month | 
| Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures |  | One Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, cancer, biopsy, PET