Clinical trial NCT00562315: FACBC PET/CT for Recurrent Prostate Cancer
Official title: 18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-22
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.

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


Eligibility 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).

Primary outcomes:
measure: Number of Participants With True Positive Scans Within the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With False Positive Scans Within the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With True Negative Scans Within the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With False Negative Scans Within the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With True Positive Scans Outside the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With True Negative Scans Outside the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With False Positive Scans Outside the Prostate Bed
timeFrame: Up to 5 years
measure: Number of Participants With False Negative Scans Outside the Prostate Bed
timeFrame: Up to 5 years
measure: Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
timeFrame: Up to 5 years
measure: Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
timeFrame: Up to 5 years
Secondary outcomes:
measure: Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
timeFrame: Up to 5 years
measure: Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David M Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
citation: Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14.
citation: Amzat R, Taleghani P, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Lewis MM, Faurot M, Bellamy LM, Goodman MM, Schuster DM. Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clin Nucl Med. 2011 Sep;36(9):800-2. doi: 10.1097/RLU.0b013e318219b47e.
citation: Jani AB, Fox TH, Whitaker D, Schuster DM. Case study of anti-1-amino-3-F-18 fluorocyclobutane-1-carboxylic acid (anti-[F-18] FACBC) to guide prostate cancer radiotherapy target design. Clin Nucl Med. 2009 May;34(5):279-84. doi: 10.1097/RLU.0b013e31819e51e3.