FACBC PET/CT for Recurrent Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00562315
• Recruitment Status: Completed
• First Posted: November 22, 2007
• Results First Posted: August 18, 2015
• Last Update Posted: June 21, 2016
• Sponsor: David M. Schuster, MD
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): David M. Schuster, MD, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: FACBC; Other: ProstaScinct	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 128 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: 18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm

Intervention/treatment

FACBC PET-CT and ProstaScint CT; Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.

Drug: FACBC; Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan; Other Name: Fluciclovine; Other: ProstaScinct; ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.; Other Name: In-Capromab Pendetide

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With True Positive Scans Within the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
2. Number of Participants With False Positive Scans Within the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
3. Number of Participants With True Negative Scans Within the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
4. Number of Participants With False Negative Scans Within the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
5. Number of Participants With True Positive Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
6. Number of Participants With True Negative Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
7. Number of Participants With False Positive Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
8. Number of Participants With False Negative Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ]
   Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
9. Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma [ Time Frame: Up to 5 years ]
   1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
   2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
   3. Accuracy = (True positives + true negatives)/all tests
   4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
   5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
10. Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed [ Time Frame: Up to 5 years ]
    1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
    2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
    3. Accuracy = (True positives + true negatives)/all tests
    4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
    5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed

Secondary Outcome Measures :

1. Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed [ Time Frame: Up to 5 years ]
   1. Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
   2. Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
   3. Accuracy = (True positives + true negatives)/all tests
   4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
   5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
2. Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma [ Time Frame: Up to 5 years ]
   1. Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
   2. Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
   3. Accuracy = (True positives + true negatives)/all tests
   4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
   5. Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

David M. Schuster, MD

National Cancer Institute (NCI)

Investigators

• Principal Investigator: David M Schuster, MD; Emory University

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT00562315
• Other Study ID Numbers: IRB00006468; R01CA129356-01 ( U.S. NIH Grant/Contract )
• First Posted: November 22, 2007
• Results First Posted: August 18, 2015
• Last Update Posted: June 21, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases