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FACBC PET/CT for Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00562315
First received: November 20, 2007
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.

This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.


Condition Intervention Phase
Prostate Cancer
 Drug: [18F]FACBC
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: 18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • We will investigate the ability of anti-[18F]FACBC PET-CT imaging to detect recurrence of prostate carcinoma in the prostate bed validated by pathologic analysis of prostate bed biopsies and patient follow-up. [ Time Frame: At time of scan and pathologic examination and patient follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigate the ability of anti-[18F]FACBC PET-CT imaging to detect extra-prostatic recurrence of prostate carcinoma validated by pathologic analysis of suspect lymph nodes sampled via percutaneous and laparoscopic methods and patient follow-up. [ Time Frame: At time of scan and pathologic examination and patient follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
0
This is a single arm study
 Drug: [18F]FACBC
[18F]FACBC is given intravenously prior to PET scan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

STUDY NOW CLOSED for recruitment

Inclusion Criteria:

  • Patients must be 18 years of age or older.
  • Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
  • In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
  • Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18.
  • Greater than T3 disease in past
  • Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
  • Does not meet above criteria of suspicious PSA elevation
  • Inability to lie still for PET scanning
  • Cannot provide written informed consent.
  • Bone scan findings characteristic for metastatic prostate carcinoma
  • Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562315

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
David M. Schuster, MD
Investigators
Principal Investigator: David M Schuster, MD Emory University
  More Information

No publications provided

Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00562315     History of Changes
Other Study ID Numbers: R01CA129356-01, NIH-7499101
Study First Received: November 20, 2007
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013