NCT02578940

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 7, 2019

Completed
Last Updated

October 7, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

October 15, 2015

Results QC Date

August 9, 2019

Last Update Submit

September 16, 2019

Conditions

Cancer of the Prostate

Outcome Measures

Primary Outcomes (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.

    1 month

Secondary Outcomes (3)

  • Response Rate to Radical Salvage Therapy

    7 months

  • PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR

    1 month

  • Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.

    1 month

Study Arms (1)

Single arm

EXPERIMENTAL

Single intravenous administration of 18F-Fluciclovine for PET Scan

Drug: 18F-Fluciclovine PET CT

Interventions

18F-Fluciclovine PET CTDRUG

Radioligand for PET CT scanning

Also known as: FACBC
Single arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mount Vernon Cancer Centre, Mount Vernon Hospital

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

St James Institute of Oncology

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Greater Glasgow & Clyde NHS Trust

Glasgow, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 37121865DERIVED

  • 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.

    PMID: 32068113DERIVED

  • 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.

    PMID: 31624865DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Peter Gardiner MB ChB, MRCP, FFPM
Organization
Blue Earth Diagnostics, Ltd.
P.Gardiner@blueearthDx.com
1-781-552-3403

Study Officials

  • Fergus Gleeson, FRCP FRCR

    The Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: PET Imaging study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 19, 2015

Study Start

November 1, 2015

Primary Completion

May 17, 2017

Study Completion

June 22, 2018

Last Updated

October 7, 2019

Results First Posted

October 7, 2019

Record last verified: 2019-09

Locations

GB(7)