Clinical trial NCT02462447: Carbon-11 Labeled Sarcosine in Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate
cancer
biopsy
PET
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2015-06-04
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Subjects with confirmed or suspected prostate cancer who will undergo a planned tissue biopsy of the known or suspected tumor

Group 2: Healthy volunteers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
timeFrame: One Month
measure: Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
timeFrame: One Month
Secondary outcomes:
measure: Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline
timeFrame: One Month
measure: Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials
timeFrame: One Month
measure: Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures
timeFrame: One Month
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Morand R Piert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 11C-Sarcosine as a Substrate of Proton-Coupled Amino Acid Transporters and First Human Application in Prostate Cancer. J Nucl Med. 2017 Aug;58(8):1216-1223. doi: 10.2967/jnumed.116.173179. Epub 2017 Mar 16.