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Cancer of the ProstatePhase 3FALCONNCT02578940

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

A Phase 3 study testing 18F-Fluciclovine PET CT in people with Cancer of the Prostate, run by Blue Earth Diagnostics at 7 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer of the Prostate
What is being tested?
18F-Fluciclovine PET CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
7 sitesUnited Kingdom
Study dates
Nov 2015to 22 Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United Kingdom7 sites

  • Greater Glasgow & Clyde NHS Trust

    Glasgow

  • St James Institute of Oncology

    Leeds, Yorkshire, LS9 7TF

  • University College London Hospital

    London, NW1 2BU

  • St Thomas' Hospital

    London, SE1 7EH

  • Mount Vernon Cancer Centre, Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

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

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

Read the 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.

Being tested
18F-Fluciclovine PET CT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-Fluciclovine PET CTDrug

    Also called FACBC

    Radioligand for PET CT scanning

Study groups in NCT02578940
Study groupRoleWhat they receive
Single armExperimentalSingle intravenous administration of 18F-Fluciclovine for PET Scan
Receives: Drug: 18F-Fluciclovine PET CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month

Secondary outcomes (3)

  1. Response Rate to Radical Salvage Therapy

    To establish the proportion of patients who have a sustained response to radical salvage therapy.

    Measured: 7 months

  2. 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

    Measured: 1 month

  3. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion17 May 2017
  4. Study completion22 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
PET Imaging study
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578940
Sponsor's protocol ID
BED-004
Acronym
FALCON
Status last verified
Sep 2019
First submitted
15 Oct 2015
Last updated
7 Oct 2019
Data monitoring committee
No

Publications

  • Andriole GL, Scarsbrook AF, Savir-Baruch B; LOCATE/FALCON Study Groups. Impact of 18F-fluciclovine PET/CT on plans for androgen deprivation therapy in patients with biochemical recurrence of prostate cancer: data analysis from two prospective clinical trials. Urol Oncol. 2023 Jun;41(6):293.e1-293.e7. doi: 10.1016/j.urolonc.2023.04.004. Epub 2023 Apr 29.

    PubMed 37121865

  • 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.

    PubMed 32068113

  • 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.

    PubMed 31624865

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 18F-Fluciclovine PET CT in people with Cancer of the Prostate, run by Blue Earth Diagnostics at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact on Patient Treatment /Management (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578940, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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