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18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).

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

- 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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

At time of scan and pathologic examination and patient follow-up

Safety Issue:


Principal Investigator

David M Schuster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

October 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Emory University Hospital Atlanta, Georgia  30322