Skip to main content
OpenTrials
Completed

NCT Number: NCT02462447

Carbon-11 Labeled Sarcosine in Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

11C-sarcosine

Drug

Radiotracer injection for PET/CT scan

11C-choline

Drug

Radiotracer injection for PET/CT scan

Primary outcomes

  1. Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients

    Time frame: One Month

  2. Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers

    Time frame: One Month

Secondary outcomes

  1. Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline

    Time frame: 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.

  2. Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials

    Time frame: One Month

  3. Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures

    Time frame: One Month

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.