NCT01777061

Brief Summary

When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign. While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer. This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

First QC Date

January 17, 2013

Last Update Submit

May 10, 2018

Conditions

Prostate Cancer

Keywords

Prostate CancerRecurrent Prostate CancerPET ScanFDG-PET[11C]AcetateC11-Acetate

Interventions

[11C]AcetateDRUG

intravenous injection of an average of 40 mCi of \[11C\]Acetate

Also known as: carbon-11 acetate [[11C]acetate], sodium acetate [11C]Acetate injection

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive for recurrent prostate cancer by PSA criteria
  • Recurrence definition:
  • Status post-operative radical prostatectomy, recurrence is defined by a PSA of greater than or equal to 0.2 ng/ml
  • Patients who have failed external beam radiation, or status post-brachytherapy, have recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment
  • Subject is able to comprehend the study objectives and provide written informed consent before the initiation of any study-related procedures.

You may not qualify if:

  • Eastern Cooperative Oncology Group (ECOG) status of ≥ 2
  • Any other concurrent malignancy
  • Patients without remission of disease (no PSA decrease)
  • Patients without recurrence of disease (PSA remains low)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

carbon-11 acetateSodium Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Wendell Yap, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Radiology

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 28, 2013

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

US(1)