FACBC Prostate Therapy Response

NCT02830880 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00073616
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

Conditions

Prostate Cancer

Keywords

Imaging; Nuclear medicine; Oncology; Radiology; Urogenital disorders

Outcome Measures

Primary Outcomes (5)

• Percent Change Assessed by FACBC PET Scan

  Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.

  Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

• Prostate Specific Antigen Level

  Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.

  Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

• Number of Participants Responding to Treatment Assessed by MRI

  Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Complete Response Unknown (CRU) * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

  Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

• Number of Participants Responding to Treatment Assessed by CT Scan

  A CT will be used to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

  After Cycle 6 (Week 17)

• Number of Participants With a Clinical Response Assessed by Bone Scan

  Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.

  Baseline, After Cycle 6 (Week 17)

Secondary Outcomes (1)

• Number of Deaths

  End of Study (up to 1 year)

Study Arms (1)

FACBC

EXPERIMENTAL

Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.

Drug: FACBC PET-CT; Other: MRI, CT, or Bone Scan

Interventions

FACBC PET-CT DRUG

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

Also known as: Fluciclovine

FACBC

MRI, CT, or Bone Scan OTHER

Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

FACBC

Eligibility Criteria

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

You may qualify if:

• Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
• Ability to lie still for PET scanning
• Ability to provide written informed consent

You may not qualify if:

• Age less than 18 years
• Inability to lie still for PET scanning
• Inability provide written informed consent
• Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.

Sponsors & Collaborators

• Emory University: lead
• Blue Earth Diagnostics: collaborator
• Nihon Medi-Physics Co., Ltd.: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Urogenital Diseases

Interventions

fluciclovine F-18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

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

dschust@emory.edu

(404) 712-4859

Study Officials

• David 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: Associate Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 13, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: September 30, 2019
• Last Updated: January 7, 2020
• Results First Posted: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)