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FACBC PET/CT for Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00562315
First received: November 20, 2007
Last updated: June 17, 2016
Last verified: June 2016
  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.

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 Intervention Phase
Prostate Cancer
Drug: FACBC
Other: ProstaScinct
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:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Number of Participants With True Positive Scans Within the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With False Positive Scans Within the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With True Negative Scans Within the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With False Negative Scans Within the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With True Positive Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With True Negative Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With False Positive Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With False Negative Scans Outside the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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

  • Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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


Enrollment: 128
Study Start Date: October 2007
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Cancer Institute (NCI)
Investigators
Principal Investigator: David M Schuster, MD Emory University
  More Information

Publications:
Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00562315     History of Changes
Other Study ID Numbers: IRB00006468  R01CA129356-01 
Study First Received: November 20, 2007
Results First Received: July 23, 2015
Last Updated: June 17, 2016
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 December 09, 2016