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Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer (FALCON)

Primary Purpose

Cancer of the Prostate

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
18F-Fluciclovine PET CT
Sponsored by
Blue Earth Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with biochemical recurrence (BCR) on the basis of:

    1. Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or
    2. Post radical prostatectomy (RP): EITHER two consecutive rises in PSA and final PSA >0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).

    i. In addition, the subject post RP, should have a PSA doubling time of ≤15 months OR PSA level ≥1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.

  • The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
  • The subject is being considered for radical salvage therapy.
  • The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.
  • The subject's Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
  • The subject should not have received androgen-deprivation therapy within 3 months of screening.
  • The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug).

Exclusion Criteria:

  • The subject has been previously included in this study.
  • The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection.
  • The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.
  • The subject has had a choline PET/CT scan within 3 months of the screening visit.
  • The subject has bilateral hip prostheses.

Sites / Locations

  • Mount Vernon Cancer Centre, Mount Vernon Hospital
  • Churchill Hospital
  • Royal Marsden Hospital
  • St James Institute of Oncology
  • Greater Glasgow & Clyde NHS Trust
  • University College London Hospital
  • St Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Single intravenous administration of 18F-Fluciclovine for PET Scan

Outcomes

Primary Outcome Measures

Impact on Patient Treatment /Management
The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.

Secondary Outcome Measures

Response Rate to Radical Salvage Therapy
To establish the proportion of patients who have a sustained response to radical salvage therapy.
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period.

Full Information

First Posted
October 15, 2015
Last Updated
September 16, 2019
Sponsor
Blue Earth Diagnostics
Collaborators
Innovate UK, Syne Qua Non Limited, IND 2 Results LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02578940
Brief Title
Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
Acronym
FALCON
Official Title
A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Earth Diagnostics
Collaborators
Innovate UK, Syne Qua Non Limited, IND 2 Results LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
Detailed Description
Proposed Research In the setting of growing single-centre evidence of superior diagnostic performance of 18F-fluciclovine PET/CT in BCR, our primary aim is to assess its clinical impact on treatment decisions in a multi-centre study in patients with BCR being considered for radical salvage treatment (with curative intent). In addition, we aim to further characterise its diagnostic performance, afforded by larger numbers of patients from multi-centre recruitment. We also aim to assess the effect of PSA level on probability of lesion detection by 18F-fluciclovine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Prostate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
PET Imaging study
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Single intravenous administration of 18F-Fluciclovine for PET Scan
Intervention Type
Drug
Intervention Name(s)
18F-Fluciclovine PET CT
Other Intervention Name(s)
FACBC
Intervention Description
Radioligand for PET CT scanning
Primary Outcome Measure Information:
Title
Impact on Patient Treatment /Management
Description
The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Response Rate to Radical Salvage Therapy
Description
To establish the proportion of patients who have a sustained response to radical salvage therapy.
Time Frame
7 months
Title
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
Description
PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT
Time Frame
1 month
Title
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
Description
Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period.
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with biochemical recurrence (BCR) on the basis of: Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or Post radical prostatectomy (RP): EITHER two consecutive rises in PSA and final PSA >0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels). i. In addition, the subject post RP, should have a PSA doubling time of ≤15 months OR PSA level ≥1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening. The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR. The subject is being considered for radical salvage therapy. The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed. The subject's Eastern Cooperative Oncology Group [ECOG] performance status 0-2. The subject should not have received androgen-deprivation therapy within 3 months of screening. The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug). Exclusion Criteria: The subject has been previously included in this study. The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection. The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents. The subject has had a choline PET/CT scan within 3 months of the screening visit. The subject has bilateral hip prostheses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fergus Gleeson, FRCP FRCR
Organizational Affiliation
The Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Vernon Cancer Centre, Mount Vernon Hospital
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St James Institute of Oncology
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Greater Glasgow & Clyde NHS Trust
City
Glasgow
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32068113
Citation
Scarsbrook AF, Bottomley D, Teoh EJ, Bradley KM, Payne H, Afaq A, Bomanji J, van As N, Chua S, Hoskin P, Chambers A, Cook GJ, Warbey VS, Han S, Leung HY, Chau A, Miller MP, Gleeson FV; FALCON study group. Effect of 18F-Fluciclovine Positron Emission Tomography on the Management of Patients With Recurrence of Prostate Cancer: Results From the FALCON Trial. Int J Radiat Oncol Biol Phys. 2020 Jun 1;107(2):316-324. doi: 10.1016/j.ijrobp.2020.01.050. Epub 2020 Feb 14.
Results Reference
derived
PubMed Identifier
31624865
Citation
Cook GJR. Performance of 18F-fluciclovine PET/MR in the evaluation of osseous metastases from castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):16-17. doi: 10.1007/s00259-019-04540-z. Epub 2019 Oct 17. No abstract available.
Results Reference
derived

Learn more about this trial

Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer

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