FACBC PET/CT for Recurrent Prostate Cancer

NCT00562315 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB00006468R01CA129356-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (10)

• Number of Participants With True Positive Scans Within the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With False Positive Scans Within the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With True Negative Scans Within the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With False Negative Scans Within the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With True Positive Scans Outside the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With True Negative Scans Outside the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With False Positive Scans Outside the Prostate Bed

  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.

  Up to 5 years

• Number of Participants With False Negative Scans Outside the Prostate Bed

  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.

  Up to 5 years

• Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma

  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

  Up to 5 years

• Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed

  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

  Up to 5 years

Secondary Outcomes (2)

• Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed

  Up to 5 years

• Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma

  Up to 5 years

Study Arms (1)

FACBC PET-CT and ProstaScint CT

OTHER

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; Other: ProstaScinct

Interventions

FACBC DRUG

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan

Also known as: Fluciclovine

FACBC PET-CT and ProstaScint CT

ProstaScinct OTHER

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.

Also known as: In-Capromab Pendetide

FACBC PET-CT and ProstaScint CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• David M. Schuster, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• 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.

  PMID: 24144687 BACKGROUND

• 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.

  PMID: 21493787 BACKGROUND

• 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.

  PMID: 21825855 BACKGROUND

• 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.

  PMID: 19387202 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David M. Schuster, MD
• Organization: Emory University

dschust@emory.edu

404-712-4859

Study Officials

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 22, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 21, 2016
• Results First Posted: August 18, 2015

Record last verified: 2016-06

Locations

US (1)