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Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Recurrent Prostate Cancer

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Trial Information

Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence


Inclusion Criteria:



1. Patients must be 18 years of age or older.

2. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 )
prostate carcinoma and have undergone what was considered definitive
non-prostatectomy therapy for localized disease.

3. In the case of cryotherapy, the procedure will have occurred at least one year in the
past. In the case of brachytherapy, or external beam radiation, treatment will have
occurred at least 2 years in the past to eliminate patients with so-called "PSA
bump."

4. Patient will have suspicion of recurrent prostate carcinoma as defined by: the
ASTRO-RTOG Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.

5. Ability to lie still for PET scanning

6. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Age less than 18.

2. Greater than T3 disease in past and/or treated with prostatectomy.

3. Less than 1 year since cryotherapy, or 2 years since brachytherapy or external beam
radiation therapy.

4. Does not meet above criteria of suspicious PSA elevation

5. Inability to lie still for PET scanning

6. Cannot provide written informed consent.

7. Bone scan findings characteristic for metastatic prostate carcinoma

8. Less than 1 month since any prior prostate biopsy (to decrease false positive uptake
from inflammation).

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Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The presence of cancer tissue inside and outside of the prostate bed.

Outcome Description:

Subjects will have a MRI and FACBC PET scan. Cancerous tissue that are seen on the scans will be biopsied.

Outcome Time Frame:

on an average one year

Safety Issue:

No

Principal Investigator

David M Schuster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

FACBC2

NCT ID:

NCT01808222

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Recurrent Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Emory University HospitalAtlanta, Georgia  30322