Carbon-11 Labeled Sarcosine in Prostate Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02462447

Enrollment

Registered

2015-06-04

Start date

2015-06-30

Completion date

2017-02-08

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate, cancer, biopsy, PET

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.

Interventions

DRUG11C-sarcosine

Radiotracer injection for PET/CT scan

DRUG11C-choline

Radiotracer injection for PET/CT scan

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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 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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026