Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease

NCT03081884 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00092595U01CA113913-11
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.

Conditions

Cancer

Keywords

Prostate cancer; Metastatic cancer; Urogenital disorders; Oncology; Radiology

Outcome Measures

Primary Outcomes (1)

• Cancer Detection Performance of FACBC PET/CT

  The performance of FACBC PET/CT for diagnosing metastatic cancer was determined by confirming the FACBC PET/CT findings to the histological analysis of the lymph nodes.

  Day 1

Secondary Outcomes (1)

• Diagnostic Performance of FACBC PET/CT and Conventional Imaging

  Day 1, Day of surgery

Study Arms (1)

FACBC PET-CT Imaging

EXPERIMENTAL

Individuals who have been diagnosed with primary prostate carcinoma and do not have definitive findings of systemic metastasis with conventional imaging will have a whole body FACBC PET-CT scan.

Drug: FACBC PET-CT Imaging

Interventions

FACBC PET-CT Imaging DRUG

Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours. Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection.

Also known as: Fluciclovine

FACBC PET-CT Imaging

Eligibility Criteria

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

You may qualify if:

• High-risk prostate cancer patients eligible for standard of care surgery
• At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) \>20, as per clinical assessment and routine guidelines
• Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

You may not qualify if:

• Definitive findings of systemic metastasis on conventional imaging.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Alemozaffar M, Akintayo AA, Abiodun-Ojo OA, Patil D, Saeed F, Huang Y, Osunkoya AO, Goodman MM, Sanda M, Schuster DM. [18F]Fluciclovine Positron Emission Tomography/Computerized Tomography for Preoperative Staging in Patients with Intermediate to High Risk Primary Prostate Cancer. J Urol. 2020 Oct;204(4):734-740. doi: 10.1097/JU.0000000000001095. Epub 2020 Apr 29.

  PMID: 32347780 RESULT

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis; Urogenital Diseases

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

dschust@emory.edu

404-712-4859

Study Officials

• Mehrdad Alemozaffar

  Emory University

  PRINCIPAL INVESTIGATOR

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will have the same intervention

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 16, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)