Carbon-11 Labeled Sarcosine in Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 11C-sarcosine; Drug: 11C-choline

• Registration Number: NCT02462447
• Lead Sponsor: University of Michigan

Brief 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.

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 Timeline

• Study First Submitted: 2015-02-27
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate Cancer	11C-sarcosine	Subjects 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	11C-sarcosine	Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes.
Prostate Cancer	11C-choline	Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.

Primary Outcome Measures

Name	Time	Method
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers	One Month
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients	One Month

Secondary Outcome Measures

Name	Time	Method
Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials	One Month
Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline	One Month	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.
Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures	One Month

Trial Locations

Locations (1)

University of Michigan Health Systems; 🇺🇸 Ann Arbor, Michigan, United States