NCT02462447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

February 27, 2015

Last Update Submit

November 7, 2017

Conditions

Prostate Cancer

Keywords

prostatecancerbiopsyPET

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

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

    One Month

  • 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

Study Arms (2)

Prostate Cancer

Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.

Drug: 11C-sarcosineDrug: 11C-choline

Healthy Volunteer

Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes.

Drug: 11C-sarcosine

Interventions

11C-sarcosineDRUG

Radiotracer injection for PET/CT scan

Healthy VolunteerProstate Cancer
11C-cholineDRUG

Radiotracer injection for PET/CT scan

Prostate Cancer

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Related 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 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.

    PMID: 28302759RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Group 1 (prostate cancer patients): Tissue biopsies from prostate cancer lesions are performed as part of routine clinical care. These tissues will however be used for research purposes. Group 2 (healthy men): No biopsies are performed in volunteers.

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Morand R Piert, MD

    University of Michigan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

February 8, 2017

Study Completion

February 8, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)