Carbon-11 Labeled Sarcosine in Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462447
• Other study ID #: HUM00091201
• Secondary ID: R21CA191052-01
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: November 7, 2017
• Start date: June 2015
• Est. completion date: February 8, 2017

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 8, 2017
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 11C-sarcosine
Radiotracer injection for PET/CT scan
• 11C-choline
Radiotracer injection for PET/CT scan

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 (11)C-Sarcosine as a Substrate of Proton-Coupled Amino Acid Transporters and First Human Application — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients		One Month
Primary	Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers		One Month
Secondary	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
Secondary	Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials		One Month
Secondary	Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures		One Month